STANDARDS

OF

PHARMACEUTICAL

PRACTICE
 TABLE OF CONTENTS

PAGE

GENERAL PREAMBLE …………………………………………………………...4

PART A – STANDARDS OF PRACTICE FOR INDUSTRIAL PHARMACY…..6

PART B STANDARDS OF PRACTICE FOR PHARMACEUTICAL IMPORT

AND WHOLESALING………………………………….………………..29

PART C – STANDARDS FO RETAIL PHARMACY PRACTICE …………….35

PART D – STANDARDS FOR HOSPITAL PHARMACY ……………………..47

PART E – STANDRDS FOR PROMOTION AND ADVERTISING OF

MEDICINES……………………………………………………………52

PART F – REGULATORY AFFAIRS ……………………………………………57

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GENERAL PREAMBLE

Following the recognition of a need for harmonization of the approach to and a

common stand on the QUALITY OF PHARMACEUTICAL PRACTICE in
Zambia, the Pharmacy and Poisons Board, with the support of the Ministry of
Health, organised a workshop in April 1993. The main theme of that workshop
was Quality Pharmaceutical Practice. The recommendations of the workshop
were contained in an abridged report.

The bridged report was endorsed by the Pharmacy and Poisons Board who also
appointed a Committee on Standards of Pharmaceutical Practice in September,
1993 to continue the work based on the recommendations of the report.

The Committee on Standards of Practice was made up of subcommittees

corresponding to the various sectors of pharmaceutical practice, thus:-

Industrial Pharmacy;
Pharmaceutical Import / Wholesaling;
Retail / Community Pharmacy;
Hospital Pharmacy; and
Pharmaceutical Regulatory Control.

The Interim Leaders of the subcommittees worked closely with the Secretariat of
the Pharmacy and Poisons Board to draw up a programme of action. A further
workshop was held from 2nd to 4th March, 1994, at Siavonga on the shores of
Lake Kariba.

The objective of that second workshop was to produce a draft document on

Standards of Pharmaceutical Practice.

Each sub-committee had produced a number of papers (four to six per group,
amounting to a total of about twenty papers). Analytical discussions of
presentations from each group culminated in the set of standards for that group;
taking into account the broad recommendations of the previous workshop as
adopted by the Board, existing practices and the recommendations of
internationally recognised organisations (such as the World Health Organisation
“Good Manufacturing Practices for Pharmaceuticals”, and International
Pharmaceutical Federation “Guide to Good Pharmacy Practice”).

The draft Standards of Pharmaceutical Practice were endorsed by the Pharmacy

& Poisons Board a few months later in 1994.

A consensus workshop on Standards of Pharmaceutical Practice for Zambia was

held in January 1995 at the Pamodzi Hotel in Lusaka.

After the consensus workshop the “Standards of Practice” were adopted by the
Pharmacy & Poisons Board.

The Standards are in Parts A,B,C,D,E, and F.

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The part on medicinal Drug Promotion (Part E was adopted from the “World
Health Organisations’ Ethical Criteria for the Promotion of Medicinal Drugs” with
a few modifications; arising from the many enquiries about guidelines on
Pharmaceutical advertising received at the Pharmacy & Poisons Board
Secretariat. Part E was prepared after the workshop at the co-ordinators’
discretion (RM Kapamba). All the other parts A,B,C,D and F have been
subjected to workshop discussions.

The scope of consultations and the level of participations and contributions for
the first and the second workshops and for the consensus building workshop
makes the standards contained here in pertinent to the Zambian context.

Periodical revisions of these standards will render them dynamic, relevant to the
contemporary practices and accommodative of new developments and advances
in Pharmaceutical Practices. The ground has been set.

These standards are very relevant to the National Drug Policy and should
provide useful guidelines for the orientation of new Pharmaceutical practitioners,
and reference for those already in Practice. The Standards also provide a
possible basis for drafting new regulations and for a monitoring system to be
used by Pharmaceutical Inspectors.

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 PART A

STANDARDS OF PRACTICE FOR INDUSTRIAL PHARMACY

PREAMBLE

The standards on Industrial Pharmacy have been formulated in order to fill the
gap in the current pharmaceutical manufacturing sector. The Zambian liberalised
economy has resulted in a lot of pharmaceutical companies wishing to enter the
pharmaceutical manufacturing sector.

It is imperative, therefore, that there are guidelines formulated to guide both:-

(i) the manufacturer on what sort of manufacturing facilities they are

expected to have to give the medicines of the right quality, safety and
efficacy, and

(ii) the pharmaceutical inspector who will use the guide as a reference when
inspecting pharmaceutical manufacturing facilities.

The standards set out here are particularly concerned with those aspects of
quality, safety and efficacy which may be affected by manufacturing processes
carried out on any scale and sets out principles applicable to such processes. It
is not, except indirectly, concerned with the safety of persons connected with the
manufacturer of medicinal products. It should not be read as augmenting nor
causing dispute with anything issued by the Ministry of Labour.

As Zambia is signatory to the World Health Organisation Certification Scheme on

the Quality of Pharmaceutical Products Moving in International Commerce, the
recommendations of the World Health Organisation on Good Manufacturing
Practices for Pharmaceutical Products (as may be revised from time to time) is
hereby fully endorsed.

1. LOCATION AND PREMISES DESIGN

Buildings should be located, designed, constructed, adapted and

maintained to suit the operations carried out in them. Equipment should
be designed, constructed, adapted, located and maintained to suit the
processes and products for which it is used. Building construction, and
equipment lay-out, should ensure protection of the product from
contamination, permit efficient cleaning and avoid the accumulation of
dust and dirt.

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2. ENVIRONMENT, GENERAL LAYOUT AND OPERATIONAL AREAS

2.1. Environment

Premises should be sited to avoid contamination from the external

environment or from other near by activities. In existing premises,
effective measure should be taken to avoid such contamination.

Premises should be constructed and maintained with the object of

protecting against weather, ground seepage and entrance, and
habouring vermin, birds, pests and pets.

Premises should be designed and laid-out in such a way that the

risk of mix up or contamination of one product or material by
another is minimised. This especially applies to premises for the
handling of highly toxic or sensitising materials such as hormones,
cytotoxic agents and certain antibiotics.

Layout (in general)

2.2.1. Each department must be separately accommodated and

provided with dedicated facilities in such a way as to allow it
to operate in accordance with the standards stipulated for
such an area.

The layout must clamp on any possibility of allowing free personnel

movement between departments.

Administrative staff must be housed in an isolated building away

from the factory just as much as refreshment facilities

Adequate lighting should be provided

Ventilation, air filtration, air handling and cooling

equipment for adequate control over air pressure micro-

organisms, dust humidity and temperature shall be
provided when appropriate for the manufacture,
processing, packing or holding of a drug product.

airfiltration systems, including prefilters and particulate

matter air filers, shall be used when appropriate on
air supplies to production areas. If air is
recirculated to production areas, measures shall
be taken to control recirculation of dust from
production. In areas where air contamination
occurs during production, the shall be adequate
exhaust systems or other systems adequate to
control contaminants.

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 air handling systems for the manufacture, processing and
packing of penicillin shall be completely separate
from those for other drug products for human use.

Manufacturing department

2.3.1. Non sterile liquid and semi-solid manufacturing unit

2.3.1.1. The whole unit should be under an imperious

smooth ceiling, demarcated with smooth
impervious walls, covered by impervious floor
preferably terrazzo or epoxy resin type and should
have drains which are equipped to prevent any
backflow.

2.3.1.2. Change-room, laundry and toilets must be located

in one segment of the unit where, between this
zone and the next one, there must exist at least
one airlock system. Weighing room must operate
under suction pressure in order to meet GMP
requirements. The air extracted from the room
should not be recirculated at all and the dust
removed must be trapped in a collecting chamber
so as to allow only clean air into surrounding and
ensure appropriate disposal of chemical waste.

2.3.2. Non sterile dry product manufacturing unit

Change-room, shower room, laundry and toilets must be located in one

segment of the unit where positive pressure ventilating the whole zone is of

magnitude in comparison with the adjacent walkway. Between this zone and

the next one there must exist at least one airlock system along the interlink

walkway. Both change room and toilet area must be provided with facilities

for washing and drying hands.

Weighing and processing rooms must be located in the

same zone. Along the passage linking the two sections
there must exist airlock systems. The rooms experience
lower positive pressure in comparison with the passages
which provide access to them.

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 However, weighing and processing rooms must operate
under suction pressure in order to meet GMP requirements.
The air extracted from these rooms should not be
recirculated at all and the dust removed must be trapped in
respective collecting chambers so as to allow only clean air
into surrounding and ensure appropriate disposal of
chemical waste.

2.4. Sterile liquid and semi-solid product manufacturing unit

2.4.1. The whole unit must be under an impervious smooth ceiling,

demarcated with smooth impervious walls, covered by
impervious floor preferably terrazzo or epoxy resin type and
should have drains which are equipped to prevent any
backflow.

2.4.2. Shower room and toilets must be located in one segment of

the unit where positive pressure ventilating the whole zone is
of much lower magnitude in comparison with that in
processing and filling. The toilet area must be provided with
facilities for washing and drying hands.

2.4.3. Weighing room, processing room, filling room, change room

and laundry must be located in the same zone. Weighing
room is linked to processing room via an airlock system.

2.4.4. High efficiency particulate air filters (HEPA) should be used

to facilitate the supply of sterile/ aseptic air to processing
rooms aseptic.

2.5. Sterile dry manufacturing unit

A production area meant for such a purpose meets all the minimum
conditions already dealt with under 2.4. above but in addition each
processing and filling equipment must have a laminar flow unit and dust
extraction system in one and full integration.

2.6. Quality control department

There should be a building fully furnished with the necessary facilities,

and depending on the tasks to be carried out may have provision for:-

physico-chemical laboratory
biological laboratory
chemical stores
documentation room and sample stores

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 2.7. Engineering and maintenance department

The department must be allocated in a separate and isolated building

with provision for:-

maintenance workshop
spare part stores
chemical stores
documentation room

2.8. Support service plant

A support service plant whether centrally controlled or not must be

allocated outside the factory building. Some of the necessary service
plant required are as follows:-

power substation
water treatment plant
pressure plant
steam generation plant
ventilation plant

The nature of their design and installation specifications as well as

maintenance procedures disqualify each of them from being housed
within a manufacturing building. The design should also take into
consideration the local regulations.

2.9. Warehouse

2.9.1. A warehouse must have an impervious smooth ceiling and

demarcated with smooth impervious walls. The whole floor
must be impervious and able to bear heavy load.

2.9.2. Cloackroom where provided and toilet area must be sited in

a different and isolated zone from the storage area. Each of
them must be provided with facilities for washing and drying
hands.

2.9.3. A warehouse must be divided into separate dedicated

functional sub-stores, with each one of them provided with
adequate working space. There should be provision for:-

incoming material receiving

raw material quarantine stores
packaging material quarantine stores
released raw materials stores
released packaging material stores
finished product quarantine stores
released finished product stores

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 despatch room
returned products stores

2.9.4. A room mean for storage of legally restricted drug

substances or their corresponding finished products must be
designed and constructed to the specifications of a strong
room.

2.9.5. Cold room should be provided where necessary.

3. ORGANISATION, PERSONNEL, TRAINING AND HYGIENE

organisation tree of a pharmaceutical set up mainly involves personnel. It

is important that the manufacturer should have an organisation chart.
There should be sufficient personnel at all levels with the ability, training,
experience and where necessary, the professional/technical qualifications
and managerial skills appropriate to the tasks assigned to them. Their
duties and responsibilities should be clearly explained to them and
recorded as written job description or by other suitable means.

Personnel organisation establishment

In a pharmaceutical organisation, the key personnel are the Head of

Production, Head of Quality Control and company pharmacist (or
qualified person or equivalent) who should independently report directly
to the Chief Executive or other top management of the company.

Persons in responsible positions should have sufficient authority to

discharge their responsibilities. Head of Quality Control department
should be able to carry out his defined functions impartially.

Persons should be assigned to take up the duties of key personnel

during the absence of the latter.

Key personnel should be provided with adequate supporting staff.

In addition there should be a person responsible for the engineering

department necessary for the maintenance of plant machinery.

Qualifications and job description

Qualifications

Key personnel responsible for supervising the manufacture

and quality control of pharmaceutical products should be
individuals whose education should include the study of an
appropriate combination of (a) Pharmacy or Pharmaceutical
sciences (b) chemistry (analytical or organic) or biochemistry
(c) chemical engineering (d) pharmacology and toxicology

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 (e) physiology or (f) other related sciences. They should
also have adequate practice. In order to gain such
experience, a preparatory period may be required, during
which they should exercise their duties under professional
guidance. The scientific education and practical experience
of experts should be such as to enable them to exercise
independent professional judgement, based on the
application of scientific principles and understanding to the
practical problems encountered in the manufacture and
quality control of pharmaceutical products.

Job description

The head of the production department generally has the

following responsibilities:-

(a) to ensure that products are produced and

stores according to the appropriate
documentation in order to obtain the required
quality.

To approve the instructions relating to production

operations, including the in-process controls
and to ensure their strict implementation

To ensure that the production records are

evaluated and signed by a designated person
before they are made available to the quality
control department.

To check the maintenance of the department,

premises and equipment.

To ensure that appropriate process validation and

calibrations of control equipment are
performed and recorded and the reports made
available.

To ensure that the required initial and continuing

training of production personnel is carried out
and adapted according to need.

The head of the quality department generally has the

following responsibilities:-

(a) to approve or reject starting materials,

packaging materials and intermediate, bulk and
finished products.

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 to evaluate batch records, to ensure that all
unnecessary testing is carried out.

to approve sampling instructions, specifications,

test methods and other quality control
procedures.

to approve and monitor analyses carried out under

contract.

To check the maintenance of the department,

premises and equipment

To ensure that the appropriate validations

including those of analytic procedures and
calibrations of control equipment are done

To ensure that the required initial and continuing

training of quality control personnel is carried
out and adapted according to need.

Company Pharmacist / Sales and Marketing

In the event that neither the Head of Production

nor the Head of Quality Control is a Pharmacist
then the Company will be required to appoint a
Pharmacist to either be a company Pharmacist or
be in charge of Sales and Marketing.

This should be a key position in the company

whose responsibilities should include:-

(i) the registration of all pharmaceutical

products made and/or marketed by the
company;

(ii) (participation in the decision making

pertaining to the type of products to be
produced / marketed by the company,
their formulation and finished dosage
forms and their labelling and packaging

to be in charge of all sales and marketing of

the pharmaceutical products
produced/marketed by the company,
bearing in mind the ethics and laws
governing all sales, advertising and
promotion of Prescription only
Medicines, Pharmacy Medicines,

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 General Sale Medicines and
Controlled Medicines.

Training

All production, Quality Control and Laboratory personnel and all other
personnel (e.g. maintenance, service and cleaning staff) whose duties
take them into manufacturing areas, or which bear upon manufacturing
activities, should be trained in the principles of Good Pharmaceutical
Manufacturing Practice and in the practice (and the relevant theory) of
the tasks assigned to them.

Training should be in accordance with written programmes approved by

the person responsible for Production as appropriate, by the person
responsible for Quality Control. Special attention should be given to
training of operators working in aseptic or clean areas, or with highly
potent, toxic, or sensitising materials.

Training should be given at recruitment and be augmented and revised

as necessary. Training records should be maintained and periodic
assessments of the effectiveness of training programmes should be
made.

High Standards of personal cleanliness to be observed by all those

concerned with production processes

All persons entering production areas should wear protective garments,

including headgear, appropriate to the processing being carried out. The
garments should be regularly and frequently cleaned and not work
outside the factory premises. Changing rooms should be provided.

Direct contact should be avoided between the operators, hands and

starting materials, intermediates and products (other than when they are
in closed containers).

There should be pre-employment medical checks, and steps should be

taken to see that no person with a disease in a communicable form, or
with open lesions on the exposed surface of the body, is engaged in the
manufacture of medicinal products.

Staff should be required to report infections and skin lesions and a

defined procedure followed when they are reported. Supervisory staff
should look for the signs and symptoms of these conditions.

Eating, drinking, chewing and smoking or the storage of food, drink,

smoking material and personal medication should not be permitted within
manufacturing areas or in any other area where they might adversely
influence product quality.

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 Note: Requirements regarding personal hygiene and protective clothing
apply to all persons (including visitors, maintenance personnel, senior
management and inspectors) entering production areas.

4.0. OPERATIONS AND DOCUMENTATION

Operations

There shall be written procedures for production and process

control designated to assure that the drug products have the
identity, strength quality and purity they support or ate
represented to possess. These written procedures,
including any changes shall be drafted, reviewed and
approved by the appropriate organisational units and
reviewed and approved by quality control department.

Written production and process control procedures shall be

followed in the execution of the various production and
process control functions and shall be documented at the
time of performance. Any deviation from the written
procedure shall be recorded.

Calibration of manufacturing equipment

All equipment used in manufacture shall be properly

serviced and will also be regularly calibrated to ensure
optimum performance.

All calibration procedures of equipment should follow

properly laid down procedures and records of these
calibrations should be kept.

There should be clean down and sanitation procedures for

manufacturing areas and equipment. Such procedures must
indicate type of cleaning and sanitation materials and
frequency of the cleaning and sanitation.

Before any manufacturing beings steps should be taken to

ensure that the work areas and equipment are clean and
free from any starting material, packaging materials,
products, product residues or documents nor required for the
current operation.

Validation

There should be a validation programme for processes for

new master formula and method and in some instant for
cleaning procedures.

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 Validation studies should be conducted in accordance with
previously defined procedures and a record made of the
results.

The extent and degree of the work will depend on the nature
and complexity of the product and process.

Starting materials

Each starting material used should comply with its starting

material specification and be labelled with the name
designated in the specification before being released for use.
Unauthorised abbreviations, codes or names should not be
used.

Each delivery or batch or material should be assigned a

reference number which will identify the delivery or batch
throughout storage and processing. This number should
appear on the container label(s) and permit access to
records which will enable full details (including analytical
reports) of the delivery to be checked. Different batches
within one material delivery should be regarded as separate
batches for sampling, testing and release purposes.

Each delivery should be visually checked on receipt for

general condition, integrity of container(s), spoilage and
possible deterioration and be sampled by personnel and
methods approved by the person responsible for Quality
Control. The samples should be tested for compliance with
the starting material specification.

Stocks of starting materials should be inspected at intervals

to ensure that the containers are properly closed and
labelled and in good condition. They should be re-sampled
and submitted for retest at the intervals given in the starting
material specification. Such re-sampling should be initiated
by the application of retest date and/or by similarly effective
documentary systems.

Materials should be issued for use only by authorised

persons, following an approved and documented procedure.
Stock records should be maintained so that stock
reconciliations can be made.

Starting materials should only be dispensed by authorised

persons, following a procedure defined in writing to ensure
that the correct materials are accurately weighed or
measured into clean, properly labelled containers. Each

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 dispensing operation should be checked independently and
the check recorded.

Segregated dispensing areas, suitably equipped to avoid

cross contamination should be provided. Specially equipped
dedicated areas may be necessary for the dispensing of
sensitising or highly toxic materials such as hormones,
cytotoxic agents and certain antibiotics.

The packaging materials used should comply with the relevant

packaging material specification.

Each delivery batch of packaging should be awarded a

reference number which will permit access to records which
will enable full details (including test reports) of the delivery
or batch to be checked.

Recording, checking, sampling and testing procedures

should be followed for each delivery, in accordance with the
packaging materials specification.

Printed packaging materials and those which contact or may

influence the product quality should be held quarantine until
released for use on the authority of the Head of Quality
Control.

Where possible printed materials should bear identifying

code numbers or marks as part of the printed text.

Packaging materials should be issued for use only by an

authorised person, using an approved and documented
procedure. Stock records should be maintained so that
stock reconciliations can be made.

Note: Lesser standards of control and documentation may

be applied to packaging materials which can have no
influence on products quality.

Intermediate products and bulk products

Each intermediate product which requires testing should be

tested in accordance and shown to comply with its
specification. The records of such tests should be included
in the batch documents.

Containers in which an intermediate product, partly packed

product, or sub batch is stored should be labelled or marked
with an indication of product identity, quality, batch and
status.

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 Finished product

A finished product should only be passed into usable stock

(i.e. stock which may be distributed, sold or supplied for use)
after it has been formally released on the authority Head of
Quality Control. Finished product evaluation should
embrace all relevant factors, including manufacturing
conditions, results of in-process testing, a review of
manufacturing (including packaging) documentation,
compliance with Finished Product Specification and
examination of the final finished pack.

Any unexplained yield discrepancies or failure to comply with

specifications should be thoroughly investigated, with
consideration extended to other batched or other products
which might also be affected.

4.1.10.Packaging instructions

Formally authorised packaging instructions should exist for

each product, pack size and type These should normally
include, or make reference to:-

(a) the name of the product

a description of its pharmaceutical form, strength and

method of application where applicable

(c ) the pack size expressed in terms of the number,

weight or volume of the product in the final container

(d) a complete list of all the packaging materials required

for standard batch size, including quantities, sizes and
types with the code or reference number relating to
the specifications for each packaging material

(e) there appropriate, an example or reproduction of the

relevant printed packing materials and specimens,
indicating where the batch number and expiry date of
the product have been marked

(f) special precautions to be observed, including a

careful examination of the packaging area and
equipment in order to ascertain the line clearance
before operations begin

(g) a description of the packaging operation, including

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 any significant subsidiary operations and equipment
to be used

(h) details of in-process controls with instructions for

sampling and acceptance limits

4.2. Documentation

Documentation is defined as being part of Quality Assurance

and its purposes are to define a system of control:-

(a) to reduce the risk of error inherent in purely oral

communication

to ensure that personnel are instructed in details of, and

follow, the procedures concerned

( c) and permit investigation and tracing of defective

products.

Documents should be designed with care and with

Particular attention to:-

the title, nature and purpose of document should be clearly

stated. The document should be laid out in an orderly
fashion, easy to check. No superseded documents
should be used.

(ii) the way the document is used and by whom should

be stated clearly.

(iii) Instructions should be in numbered steps, clear,

precise, unambiguous and in a language the user can
understand.

(iv) if entry of data is required then:-

sufficient space should be provided

show headings clearly indicating what is to be entered

(c ) persons making entries should do so in clear

writing.

Only necessary data should be contained in documents.

Documents should be kept up to date

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 A documentation system should include provision for
periodic review if necessary.

It may be useful to prepare a manual which describes the

overall Quality Assurance Control system, the procedures
employed and the documents used with any similar labels
previously applied by the material supplier (e.g. they should
be a House Style or bear the Company logo). As the status
of the materials changes, the status labels should be
changed accordingly.

Master formula and manufacturing record

A formally authorised Master Formula should exist

for each product and batch size to be
manufactured. The master formula
should be dated and include:-
- product name
- product identification number -
dosage
- dosage form
- ingredients by item number, by
name, and by theoretical quantity
- total theoretical weight or volume
of the dosage form
- approval date
- approval signature(s)

4.2.1.2. Master method

The master method should contain the

following:-

Identification – product name, product

identification number, dosage, dosage
form and master formula

Instructions – complete manufacturing

instructions including all aspects of the
process, such as weight or measure of
each raw material added, order of
addition of raw materials, point of
addition, theoretical weight at applicable
phases, yield, major equipment used,
temperature. Any precautions
necessary to produce a successful
product.

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 Approvals – approval date and
signature(s) should be included.

4.2.1.3. Manufacturing record(s)

The elements of this are similar to the

manufacturing documents.

Identification: product name, product

identification number, dosage, dosage
for, together with the batch number and
the expiration date.

Documentation: this includes an

accurate reproduction of the master
production document and all the
necessary forms and documents listing
dates, times, people, equipment,
weights and measures, samplings,
inspections, actual yields, in process
checks recording charts, to make certain
were followed exactly.

Product manufacturing records must be

kept for two years after expiry of finished
product.

Approvals: signatures are required of

the personnel performing the significant
operations. Signature of personnel
reviewing and confirming those
operations, and signatures of the quality
control personnel who have reviewed
the completed batch record.

Specifications for raw material, packaging materials

intermediate products and finished products

There should be specifications approved by the person who is the head of

Quality Control for each starting material packaging materials intermediate
products and finished products.

Identifications: item name, item identification number

and description of item.

Tests: a list of the test to be conducted on the

materials.

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 Limits: quantitative limits (where possible) in the
forms of a quantitative upper limit and lower limit or a
plus minus figure. Limits should be sufficiently
discriminating to enable the analysis to determine
whether the item meets specifications.

Test method number: an identification of the method

used to perform the test.

Approval: date and signature of the Head of Quality

Control authorising the specifications

5.0. GOOD LABORATORY PRACTICE

It is essential that Quality Control Laboratories should have appropriate

facilities, with properly trained, managed and motivated staff, in order that
reliable results may be obtained from any analytical or other test
procedure, whether its nature is chemical, physical, biological or
microbiological steps should be taken to ensure the reliability of the
laboratory’s own systems and test methods.

5.1. Laboratory equipment: Calibration programme

The control laboratory equipment and instruments should be appropriate

to the testing procedures to be undertaken.

Equipment and instruments should be serviced and calibrated at

suitably specified intervals by an assigned person, persons or
organisation and readily available records maintained for each
instrument or piece of equipment. These records should indicate
when the next calibration or servicing is due.

5.2. Handling of reagents and reference standards

5.2.1. The reagents should be dated upon receipt or preparation.

Reagents made in the laboratory should be prepared by a

competent person following laid down procedures.

Labelling should indicate:-

- concentration
- standardisation factor
- shelf-life and storage conditions

The label should be initialised and signed

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 5.2.2. Reference standards

Reference standards and any secondary standards prepared

from them, should be dated and stored and handled
according to required storage conditions, secondary
revalidated after a year. The storage conditions should not
undermine product quality. Appropriate containers should
be use. Amber coloured bottles should be used to prevent
light from light sensitive products.

5.3. Operating and cleaning instructions for laboratory equipment

and instruments

There should be operating instructions for the operation of laboratory

equipment.

- Many suppliers of equipment will supply with their equipment

users manual of instructions on its operation.

- if one is not supplied then one should be prepared for every

equipment and these instructions should also be available.
There should be instructions available for:-

cleaning instructions should also be available. There should be

instructions available for:-

- spectrophotometric cells
- flushing of HPLC systems and columns
- any other instruments that may be used for different samples
and may lead to cross contaminations if not properly cleared.

5.4. Sampling and sample handling

There should be established sampling and sample handling procedures.

The size of the sample and the sampling procedure varies with the type
of materials that re to be sampled. Each sampling procedure include the
following:-

Identification: title

Scope: the type of material covered by the sampling procedure.

Preparation for sampling: assembly and cleaning of containers,

aseptic sample preparation and so on.

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 Sample size: the quality of sample that is to be taken to permit
complete testing.

Sampling procedure: how the sample is to be taken, the equipment

to be used, the number of containers to be opened and the marking
of sample containers.

Sample retention: the length of time that sample are kept before
they are discarded.

5.5. Examination and testing procedures

The persons responsible for laboratory management should ensure that

suitable test methods, validated in the context of available facilities and
equipment, are adopted or developed.

Each chemical, physical or microbiological test method should contain

the following:-

- title
- summary
- list of equipment needed
- procedure
- calculations
- reference (source of the technique, validation of the method
and so on).

The method used must be recorded and accurately followed to prevent

variation of results.

5.6. Certificate of analysis

A certificate of analysis must be issued by Quality Control and should

indicate the type of analysis that was done and the results that were
obtained for the goods. The certificate of analysis should:-

identify the organisation issuing it, bee signed by a person

competent to do so and indicate his qualifications,

(ii) name the material to which it refers and identify it by a batch

number,

(iii) state that the material has been tested, by whom and when
this was done

(iv) state the specification (e.g. B.P.) and methods against

which, and by which the tests were performed

22
 (v) Give the rest results obtained, and declare that the results
obtained showed compliance with the stated
specifications.

5.7. Stability study

There shall be a written testing programme designated to assess the

stability characteristics of drug products. The results of such stability
testing shall be used to determine appropriate storage conditions and
expiration dates. The written programme shall be followed and shall
include:-
sample size and test intervals based on a statistical criteria for each
attribute examined to assure valid estimates of stability.

(ii) storage conditions for samples retained for testing

(iii) reliable meaningful and specific test methods

(iv) test the drug products in the same container-closure

system as that in which marketed

accelerated studies combined with basic stability information on

the components, drug products and container closure system,
may be used to support tentative expiration dates provided full
shelf-life studies are not available and are being conducted.

5.8. Reserve sample

An appropriately identified reserve sample that is representative of each

lot in each shipment of each active ingredient shall be retained. The
reserve sample consist of at least twice the quantity necessary for all
tests required to determine whether the active ingredient meets its
established specifications.

For an active ingredient in a drug product, the reserve sample shall be

retained for two years after the expiration date of the last lot of the drug
product containing the active ingredient.

6.0. REJECTED AND RECOVERED MATERIALS

Product complaint handling system

There should be a complaints handling system. The complaints should

be handled by the Head of Quality Control Department following the laid
down written procedures.

23
 Rejected and recovered materials

Rejected materials and products should be clearly marked as such and

stored separately in restricted areas. They should either be returned to
the suppliers or where appropriate, reprocessed or destroyed. Whatever
action is taken should be approved by authorised personnel and
recorded.

The reprocessing of rejected products should be exceptional. It is

permitted only if the quality of the final product is not affected, if the
specifications are met, and it it is done in accordance with a defined and
authorised procedure after evaluation of the risks involved. A record
should be kept at the reprocessing. A reprocessed batch should be
given a new batch number.

The introduction of all or part of earlier batches, conforming to the

required quality, into a batch of the same product at a defined stage of
manufacture should be authorised beforehand. This recovery should be
carried out in accordance with a defined procedure after evaluation of the
risks involved, including any possible effect on shelf life. The recovery
should be recorded.

The need for additional testing of any finished product that has been
reprocessed, or into which at a recovered product has been incorporated,
should be considered by the quality control department.

Recalled products

There must be in a place a system for product recall handled by head of

Quality Control. Recalled products should be identified and stored
separately in a secure area until a decision is taken on their fate. The
decision should be made as soon as possible.

Returned goods

Products returned from the market should be destroyed unless it is

certain that their quality is satisfactory; they may be considered for
resale, relabelling, or bulking with a subsequent batch only after they
have been critically assessed by the quality control department in
accordance with a written procedure. The nature of the product, any
special storage conditions it requires, its condition and history, and the
time elapsed since it was issued should be taken into account in this
assessment.

Where any doubt arises over the quality of the product, it should not be
considered suitable for reissue or reuse, although basic chemical
reprocessing to recover the active ingredient may be possible. Any
action taken should be appropriately recorded.

24
 Expired goods

Expired goods must be disposed of within six months of expiration date.

7.0. WASTE MATERIALS, PESTICIDES AND SANITIZING MATERIALS

Waste materials

Provision should be made for the proper and safe storage of waste
materials awaiting disposal. Toxic substances and flammable materials
should be stored in suitably designed, separate, enclosed cupboards, as
required by national legislation.

Waste material should not be allowed to accumulate. It should be

collected in suitable receptacles for removal to collection points outside
the buildings and disposed of safely and in a sanitary manner at regular
and frequent intervals.

Pesticides, sanitizing materials, etc

Rodenticides, insecticides, fumigating agents and sanitizing materials

should not be permitted to contaminate equipment, starting materials,
packaging materials, in-process materials, or finished products.

8.0. SELF-INSPECTION AND QUALITY AUDITS

8.1. Introduction

Written instructions for self-inspection should be established to provide a

minimum and uniform standard of requirements. These may include
questionnaires on GMP requirements covering at least the following
items:-

personnel
premises including personnel facilities
maintenance of building equipment
storage of starting materials and finished products
equipment
production and in-process controls
quality control
documentation
validation and revalidation programmes
calibration of instruments or measurement systems
sanitation and hygiene
recall procedures
complaints management
labels control
results of previous self-inspections and any corrective steps taken

25
 8.2. Self-inspection team

Management should appoint a self-inspection team from local staff who

are expert in their own fields and familiar with GMP. The members of the
team may be appointed from inside or outside the company.

Frequency of self-inspection

The frequency at which self-inspections are conducted may depend on

company requirements.

Self-inspection report

A report should be made at the completion of a self-inspection. The

report should include:-

self-inspection results
evaluation conclusions
recommended corrective actions

Follow-up action

The company management should evaluate both the self-inspection

report and the corrective actions as necessary.

Quality Audit

It may be useful to supplement self-inspections with a quality audit. A

quality audit consists of an examination and assessment of all or part of a
quality system with the specific purpose of improving it. A quality audit is
usually conducted by outside or independent specialists or a team
designated by the management for this purpose. Such audits may also
be extended to suppliers and constructors (see section 9, “contract
manufacture and analysis”).

Suppliers’ audits

The quality control department should have responsibility together with

other relevant departments for approving suppliers who can reliably
supply starting and packaging materials that meet established
specifications.

Before suppliers are approved and included in the specifications they

should be evaluated. The evaluation should take into account a
supplier’s history and the nature of the materials to be supplied. If an
audit is required, it should determine the supplier’s ability to conform with
GMP standards for active pharmaceutical ingredients (see WHO
recommendations).

26
9.0. CONTRACT MANUFACATURE AND ANALYSIS

Contract production and analysis must be correctly defined, agreed and

controlled in order to avoid misunderstandings that could result in product,
work or analysis of unsatisfactory quality. There must be a written
contract between the contract giver and the contract accepter which
clearly establishes the duties of each party.

The contract must clearly state the way in which the authorised person, in
releasing each batch of product for sale or issuing the certificate of
analysis, exercises his or her full responsibility.

All arrangements for contract manufacturer and analysis, including any

proposed changes in technical or other arrangements, should be in
accordance with the marketing authorisation for the product concerned.

There should be a written contract covering the manufacture and / or

analysis arranged under contract and any technical arrangements made
connection with it. The contract should permit the contract giver to audit
the facilities of the contract accepter. In the case of contract analysis, the
final approval for release must be given by the authorised person(s).

The contract giver

The contract giver is responsible for assessing the competence of the

contract accepter in successfully carrying out the work or tests required
and for ensuring by means of the contract that the principles of GMP
described in this guide are followed. The contract giver should provide
the contract accepter with all the information necessary to carry out the
contracted operations correctly in accordance with the marketing
authorisation and any other legal requirements. The contract giver
should ensure that the contract accepter is fully aware of any equipment,
personnel other materials or other products. The contract giver should
ensure that all processed products and materials delivered by the
contract accepter comply with their specifications or that the product has
been released by the authorised person(s).

The contract accepter

The contract accepter must have adequate premises, equipment,

knowledge and experience and competent personnel to carry out
satisfactorily the work ordered by the contract giver. Contract
manufacture may be undertaken only by a manufacturer who holds a
manufacturing authorisation.

The contract accepter should not pass to a third part any of the work
entrusted to him or her under the contract without the contract giver’s
prior evaluation and approval of the arrangements. Arrangements made

27
 between the contract accepter and any third party should ensure that the
manufacturing and analytical information is made available in the same
way as between the original contract giver and contract accepter. The
contract accepter should refrain from any activity that may adversely
affect the quality of the product manufactured and / or analysed for the
contract giver.

The contract

A contract should be drawn up between the contract giver and the

contract accepter that specified their respective responsibilities relating to
the manufacture and control of the product. Technical aspects of the
contract should be drawn up by competent persons suitably
knowledgeable in pharmaceutical technology, analysis and GMP. All
arrangements for production and analysis must be in accordance with the
marketing authorisation and agreed by both parties.

The contract should specify the way in which the authorised person
releasing the batch for sale ensures that each batch has been
manufactured in, and checked for compliance with the requirements of
the marketing authorisation. The contract should describe clearly who is
responsible for purchasing, testing and releasing materials and for
undertaking production and quality controls, including in-process
controls, and who has responsibility of sampling and analysis. In the
case of contract analysis the contract should state whether or not the
contract accepter should take samples at the premises of the
manufacturer.

Manufacturing, analytical and distribution records and reference samples

should be kept by, or be available to the contract giver. Any records
relevant to assessing the quality of a product in the event of complaints
or a suspected defect must be accessible and specified in the defect /
recall procedures of the contract giver.

28
 PART B

STANDRADS OF PRACTICE FOR PHARMACEUTICAL IMPORT AND

WHOLESALING

PREAMBLE

Pharmaceutical products before they are made available for use by the medical
profession for treatment are subjected to long and expensive processes of
research, development and licensing to ensure safety, efficacy and quality.

Pharmaceutical wholesale distributors form part of the supply chain of

pharmaceutical products and they are responsible for the effective and efficient
handling, storing and distribution of such products in order that they reach the
patient promptly on demand and in perfect condition.

All pharmaceutical wholesale distributors should therefore, endeavour to

establish and maintain the following as the minimum standards for procurement,
storage and distribution.

1.0. PERSONNEL

Management – to be in the hands of a fully registered pharmacist who

should have full, direct, ethical and legal responsibility for procurement,
storage, sales / distribution. Covering pharmacist should not be
entertained. A full time Pharmacy Technologist must be mandatory unless
the Pharmacist is also the proprietor.

Supporting technical personnel

All sales and marketing functions should be carried out by
pharmaceutically qualified and competent personnel i.e. pharmacist or
pharmacy technologist.

Auxiliary personnel
Other personnel will be necessary ot be employed as necessary as befits
the scale of operation. Basic in service training should be done to make
them aware of the special nature of the products they would be handling.

Interim management
It should be mandatory for management to submit to the registrar the
names of legally responsible personnel. If the pharmacist is out for period
of more than 4 weeks it should be mandatory for the company to employ
full time a locum pharmacist. For a period of less than 4 weeks, the
pharmacy technologist will act with the help of a part-time pharmacist.

29
2.0. OPERATIONS

2.1. licensing

Certificate of incorporation
(ii) Import / export licence from Pharmacy & Poisons Board
(iii) Dealers licence from Pharmacy & Poisons Board
(iv) Trading (wholesale) licence
Practitioners annual practising licence / certificate of
registration
(vi) Tax exemption certificate (where relevant)
(vii) Product licences

2.2. Procurement

The pharmacist should select items to be imported taking into

consideration:-

(i) The list of drugs registered or registrable in Zambia

(ii) Product information of drugs imported
(iii) From suppliers who participate in the WHO certification
scheme
(iv) Zambia National Formulary

2.3. Storage

The pharmacist and warehouse staff will raise the necessary

documentations and ensure the correct storage conditions of the
received goods.

Distribution

The pharmacist must ensure that goods are distributed to those properly
authorised to legally deal in the respective products. The principles of
first in first out must be adhered to strictly, to minimise loss through
expiring. Invoices must reflect the following details.

i. Name and address of seller

ii. Name and address of buyer
iii Internationally recognised pharmacopoeias e.g. B.P, .S.P.
I.P.
iv. Zambia National Formulary
v. Martindale The Extra Pharmacopoeia

30
3.0. PREMISES FACILITIES AND EQUIPMENT

Location

The premises should be situated within a commercial or light industrial

area with a minimum floor space of 100sq metres (m2) 75% of this space
should be the actual storage space.

The building should be distinctly separated into administrative and

warehousing areas.

3.2. Warehouse

There should be adequate and separate space for the following:-

(i) receipt of goods / quarantine

(ii) bulk storage of goods
(iii) Assembly and packing
(iv) repacking of medicines
dispatch area

Ablution facilities for warehouse personnel maybe located within but

separate from storage areas.

3.3. Administrative area

Separated from warehouse and should include:-

(i) Reception / secretarial office

(ii) Manager’s office
(iii) Technical managers office / pharmacist
(iv) Sales office
Showroom secure and separate
(vi) Ablution facilities for customers and staff
(vii) Guard-room

3.4. Construction

3.4.1. Storage areas

Floors, walls and where possible the ceiling should have

smooth crack free surface partitioning within the warehouse
should be of concrete blocks or heavy wire mesh walls that
reach up to the ceiling

Concrete block walls and ceiling together with steel doors

should be mandatory for any narcotics storage area.
Similarly flammables storage area should be constructed of
fire proof materials and located outside the main warehouse.

31
 3.4.2. Administration

Partitioning of offices may be made of alternative materials

like wood or aluminium. The prime concern being the
security of records.

The storeroom should be security, constructed, the ceiling in

all storage areas should be sufficiently burglar proof.

3.5. Climate control and lighting

3.5.1. Temperature in the general storage area should be

maintained at 15 degrees centigrade and should never
exceed 20 degrees centigrade. Air conditioners should be
installed to maintain these temperatures. Thermometers
should be in place to monitor the temperatures.

3.5.2. Relative humidity should be maintained at 60% + - 5%

humidifiers should be mandatory, especially for the rainy
seasons.

3.5.3. lighting suitable for each working area should be provided.

In general fluorescent lighting will be adequate whilst walls
should be painted in light pastel shades

3.6. Security and fire protection

3.6.1. Security – burglar proof bards and grilles should be fitted on

all windows and doors.

3.6.2. Fire protect – fire proof materials should be used in

construction where possible fire fighting equipment should
always be in place at all times. Fire alarms and sprinkler
systems should be mandatory.

3.7. Equipment and facilities

3.7.1. Ware house – there should be an adequate number of metal

shelving, large metal top tables for assembly of orders,
trolleys, pallets, pallet trolleys as befits the scale of
operation.

There should be available adequate packaging materials

(cartons, strapping, labelling, etc), there should be available
suitable covered transport e.g. pick-up or truck.
3.7.2. Administration – adequate facilities and equipment should be
available to ensure efficient operations, as follows:

32
 Telephone / fax / telex
Ward processors
Printer / photo copiers

4.0. QUALITY ASSURANCE IN PHARMACEUTICAL SUPPLY SYTEM

Product selection

Procurement of medicines should be restricted to those that have been

registered in this country and those included in the Zambia National
Formulary or the WHO Essential Drug list.

Supplier selection

Medicines should be procured only from manufacturers participating in

the WHO Certification Scheme, or reputable suppliers who in turn,
purchases from similarly certified manufacturers.

Receipt

Government appointed inspection firms e.g. government appointed firms

should be contractually obligated to include quality control of
pharmaceuticals destined for Zambia as part of their pre-shipment
inspections.

Ensure that required certificates of analysis are presented together with

import documents.

Inspect shipment contents to assure adherence to contract

specifications.

Have samples analysed routinely, at random, or for suspect products at

an independent National Quality Control Laboratory or at any other
recognised Regional Drug Quality Control.

Storage

Continuously monitor storage conditions to ensure that an acceptable

storage environment is maintained throughout the supply chain.

Transportation

Provide suitable transportation modes and schedules to ensure all

products are appropriately conveyed.

Repackaging

Select repacking systems to assure that they are suitable for the product
and the local environment.

33
 Monitor packaging equipment, materials and techniques to ensure that
adequate closure is maintained.

Complaints

Any complaint concerning a defective product should be recorded and

thoroughly investigated and prompt remedial measures taken.

Product recall

There should be in place an effective system to recall from the market

promptly and effectively products known or suspected to be defective.

This requires the maintenance of comprehensive and readily accessible

distribution records.

34
 PART C
STANDARDS FOR RETAIL PHARMACY PRACTICE

PREAMBLE

A retail pharmacy business means a business (not being a professional practice

carried on by a medical practitioner) which consists of or includes the retail sale
of medicinal products other than medicinal products on a general sale list
(whether medicinal products on such a list are sold in the course of that business
or not).

The quality of pharmaceutical practice in a retail pharmacy is a function of a

number of factors – some of which are:-

Ethical conduct of a particular pharmacist, the type of premises he or she

operates from, the type of tools he or she uses and the condition of the products
he or she supplies to the community. The pharmacist must be incessantly
cognizant of his/her role in the provision of health service, particularly
pharmaceutical care, to the public and the place he / she occupies vis a vis other
health workers on the one hand and the pharmaceutical industry on the other.

The pharmaceutical industry has made great strides in the development of new
and more effective drugs. Such have been these strides that now almost all
dosage forms of medication originate from large pharmaceutical factories and as
a consequence prescribing habits of medical practitioners have undergone
changes. In turn, the manner in which prescriptions are dispensed by
pharmacists has also changed. For instance, extemporaneous compounding of
medicaments no longer constitutes the bulk of a retail pharmacist’s dispensing
routine because more and more prescriptions are for products such as tablets,
capsules and liquid preparations which are specialities of the pharmaceutical
industry.

However this development does not reduce the role of, nor displace, the
pharmacist in the provision of health service to the community. The nature of the
new drugs is so delicate and specialised that handling them and ensuring their
appropriate and proper use requires not only expert knowledge but also suitable
and specialised premises, equipment, facilities and operational systems,
arrangements and procedures. Only this way we can the quality, efficacy and
safety of the medicinal products supplied to the community be assured. Whether
these medicines are by prescription or over the counter. The pharmacy law in
Zambia recognises this by demanding that every retail pharmacy business must
be under the personal management and control of a duly registered pharmacist.
In order for the pharmacist to achieve this objective certain standards of Good
Pharmacy Practice must be in place, including those described in this part, as a
minimum.

These minimum standards are, of course, neither static nor exhaustive. All
pharmacists must continually keep abreast of new developments in
pharmaceutical practices in Zambia and internationally.

35
1. STANDARDS FOR PREMISES

Appearance of premises

The external appearance of retail pharmacy premises must inspire

confidence in the nature of the health care that can be provided.

The premises should be identified distinctly by a sign post with following

details:-

- name of pharmacy
- address
- telephone number
- operating times on door or window and
- specific symbol for pharmacies: Green Cross
with white black background

The sign post shall be stocked and supplied by the Pharmacy and Poisons
Board.

Safety of premises

Working conditions must be so arranged as to protect the safety of the

public and people working on the premises.

Fire fighting system should be available on the premises.

1.3. Conditions of premises

The walls, floors, windows, ceiling, wood work and all other parts of the
premises must be:-

- clean
- in good order
- finished in a smooth impervious material

1.4. Tidiness of premises

All parts of the premises must be maintained in an orderly and tidy

condition.

Food should not be consumed in the main shop or dispensary.

1.5. Environment

(a) products must be protected from adverse effects of light,

high temperature and humidity.
(b) All parts of the premises must have suitable and effective
means of lighting and ventilation.

36
 (c) Background music must not be played at such a volume as
to cause distraction.
(d) The retail pharmacy must be in an area where fumes and
other emissions from factories will not enter the premises to
adulterate the merchandise stored within.

1.6. Arrangements

(a) Arrangements of stocks/merchandise and relative space

apportioning should give prominence to the professional
aspects of the retail pharmacy business.
(b) Particular consideration should be given to:-

(i) arrangements for patient/customer;

- confidentiality
- access
- convenience and
- information/communication

A place should be designated for patient

counselling/and confidential consultations.

(ii) Over the counter (OTC) sales should be

so displayed/stocked as to allow
sufficient professional supervision.

(iii) Prescription sales should be done under

the direct supervision of a pharmacist
and products should be stocked within
the dispensary.

(iv) special security should be in place for

drugs such as narcotics, psychotropic
drugs and other controlled
drugs/substances and those potentially
attractive or liable to abuse.

Veterinary products and agrochemicals should

be stocked distinctly

Dietary supplements / special food products

should be distinctly stocked.

Cosmetics and toiletries should be differently

displayed.

37
 1.7. Minimum size of dispensary and pharmacy premises

1.7.1. Dispensary

The size of the dispensary must reflect the volume of

prescriptions dispensed and should allow safe and efficient
flow of work.

Recommended minimum size for a dispensary:-

Length - 500cm
Width - 300cm
Height - 360cm

1.7.2. Main shop – minimum size: 50sq metres

1.7.3. Consultancy room: 4sq metres

1.7.4. Storeroom: 24 sq metres

1.7.5. Toilet: 2sq metres

1.7.6. Office: 3sq metres

1.8. Hygiene

Toilet facilities should be available and hand washing facilities should

also be available.

Toilets must not in any case open directly into the dispensary.
“No smoking” signs must be put in places where they are easily noticed
and read.

Food should not be consumed in the main shop or dispensary.

Dustbins must be provided and always covered.

1.9. Certificates

The following certificates must be displayed in the main shop:-

1.9.1. Certificate of registration of pharmacist manager

1.9.2. annual practicing licence of the pharmacist manager
1.9.3. certificate of registration of pharmacy premises with the
Pharmacy, Medicines and Poisons Board
1.9.4. certificate of incorporation where necessary
1.9.5. trading licence
1.9.6. fire safety certificate from local authority

38
2.0. STANDRDS FOR DISPENSARY DESIGN AND EQUIPMENT

2.1. suitability of dispensary

The dispensary, its fittings and equipment must be suitable for the
purpose of dispensing.

Dispensary should be separate from rest of shop by a lockable door.

2.2. Work surface and shelves

(a) Working surfaces, cupboards and shelves must be in a good

state of repair and in a clean, tidy condition. They must be
smooth, washable and impervious to moisture. The work
surface must have a minimum number of joints which must
be sealed to prevent ingress of moisture or liquids.

(b) A clean area of bench space at a comfortable height must be

set aside for dispensing, about 1 metre high.

(c) Care must be taken to avoid obstruction by labelling and

other equipment.

(d) The work surface must be big enough to write on and

accommodate all the machinery and equipment needed.

2.3. Floor covering

The floor covering in the dispensary must be water resistant and easy to
clean. The floor must have smooth concrete tiles or terrazzo.

2.4. Water supply

(a) The dispensary must be provided with a source of potable

water. Therefore, a geyser must be installed in the
pharmacy for hot water. Water purifying equipment is also
recommended.

(b) a sink of durable material (e.g. stainless steel) must be

provided in the dispensary with ht and cold running water.

2.5. Waste disposal

(a) Suitable and adequate means of waste disposal must be

available and in use. A pedal dustbin must be available.

(b) Waste material must not be allowed to accumulate.

39
 2.6. Dispensary equipment, a minimum of the following:-

(a) Pestle and mortar

(b) Weighing balance
(c) Glass or ceramic slabs
(d) Tablet counting trays or counting machines
(e) Typewriter
(f) Water distiller
(g) Stools and waiting bench for patient / customers awaiting
service/consultation
(h) Computer (optional)
(i) Measuring cylinder and conical flask
(j) Refrigerator

2.7. Reference books, a minimum of the following:

(a) Martindale The Extra Pharmacopoeia

(b) The International pharmacopoeia / European
Pharmacopoeia / British Pharmacopoeia
(c) Data sheet compendium
(d) Pharmacy law and Ethics / Pharmacy & Poisons Act,
Therapeutic Substances Act, Dangerous Drugs Act or other
relevant legislation on pharmacy, medicines and poisons at
the time in force in Zambia
(e) Zambia National Formulary
(f) British National Formulary
(g) MIMMS AFRICA
(h) Other references and information sources on Pharmacy
practice Pharmaceutical Care.

3.0. STANDARDS OF PROCUREMENT

Pharmaceutical aspects of the purchase of all medicinal and elated

products must be done by a pharmacist and must be purchased from
registered dealers / manufacturers with Pharmacy, Medicines and Poisons
Board and must be of right quality.

Good purchasing considers six rights:-

(a) Right quality i.e. the performances and suitability of items.

(b) Right quantity – this should be according to requirements
determined by consumption levels.
(c) Right time – should take into account seasonal demands
(d) Right delivery – the delivery should also be as and when required.
(e) Right price – the price should be in accordance with quality.
(f) Right supplier – the materials should be from a reputable supplier.
In the case of pharmaceuticals only dealers / manufacturers
registered with the Pharmacy, Medicines and Poisons Board should
supply.

40
 Pharmacies should keep an inventory of drugs in stock room to include
the following details:-

- Date
- Products
- Supplier / manufacturer
- Invoice
- Quantity

4.0. STANDARDS FOR DISPENSING

4.1. dispensing procedure

- Prescriptions should be:-

(a) legible
(b) be by a recognised prescriber and show:-

- official stamp and name in block letters

- signature of prescriber
( c) Prescriber means registered Medical Practitioner /
Dentist / veterinary surgeon or other legally
authorised category, as the case may be;

(c) There should be a Standard prescription form made

by Medical Council in conjunction with Pharmacy,
Medicines and Poisons Board Medical Council
registration number.

(d) dispensing should be done by a pharmacist or under

the direct supervision of a pharmacist by a pharmacy
technician.

(e) Prescription should be kept for at least two (2) years.

4.2. Supervision of dispensing and sales

The use of dispensing cards should be considered with reference

numbers. Supervision of all dispensing and sale of pharmacy medicines
and general sale medicines should be done by pharmacist.

4.3. Safety in dispensing procedure

- Carelessly written prescription should not be attended to

- if in doubt contact prescriber

- the pharmacist must not be distracted by loud noise, music

and other staff.

41
 4.4. Forged prescriptions

To minimise forgeries, the pharmacy must keep an updated list of:-

(i) General practitioners

(ii) Veterinary surgeons
(iii) Dental practitioners

Together with a sample of their signatures.

Prescriptions from clinical officers, nurses, midwives and others must not
be dispensed.

4.5. Dispensing containers should be:-

- clean
- possible to close and open
- must have a space for labelling

4.6. Re-use of containers

- if able to fulfil conditions in 4.5 above then a container can

be re-sued but re-use of containers generally is not to be
encouraged.

4.7.1 Re-use of medicines

Under no circumstances must medicines be re-used

Expired drugs and obsolete drugs

Expired drugs and obsolete drugs must be disposed of as required by

law.

4.8. Labels

Need for printed labels: handwritten labels should not be encouraged.

Labelling should include:-

- Generic name of drug

- dosage
- administration route and method
- warning where necessary
- total quantity of drug
- date
- name of patient
- name and address of pharmacy

42
 4.9. Record keeping

Prescription should be properly filed for at least 2 (two) years before

disposing of them. Record keeping should include record of suppliers.

4.10. Copy prescriptions

When a pharmacist does not have all medicines on a prescription, he /

she should dispense that which is available and retain a copy
prescription. The original should be given to the patient provided he
indicates / crosses off which drug has been dispensed.

4.11. Storage

Storage should be:-

- done according to manufacturer’s instructions

- in original manufacturer’s containers
- conform to warehousing requirements

4.12. Recalls

Pharmacists should comply immediately when there is recall of any

(medicinal) product.

4.13. Personal hygiene

- high hygiene standards are required – including clean

clothing
- tablet counting should be done using tablet counting trays
- while laboratory coats, or other uniform prescribed by
relevant regulation should be worn.

5.0. STANDARDS FOR PERSONNEL, EDUCATION, TRAINING,

DEVELOPMENT, ADMINISTRATION, MANAGEMENT AND
PROFESSIONAL INDEMNITY

5.1. Personnel

In a community pharmacy there are two (2) kinds of staff:-

(a) pharmaceutically qualified and

(a) pharmaceutically qualified personnel are:-

(j) pharmacists

(ii) pharmacy technicians

43
 (i) Pharmacists – must have a degree in Pharmacy
from a recognised university and be fully registered
with the Medical Council of Zambia or any other body
charged with registration; and possess current annual
practising certificate.

(ii) pharmacy technicians must:

(a) have a diploma in Pharmacy

(b) be on full registration and
(c) possess current annual practising certificate

(iii) Auxiliary staff include:-

(a) Pharmacy shop assistants

(b) Till operators
(c) Cleaners
(d) Security guards

Pharmacy assistant: Grade 12 with good command

of English and ability to communicate in local
language.

Till operators – at least Grade 10 standard of

education with working knowledge of the till.

Cleaners – ability to work diligently with minimum

supervision

Guards – should be security conscious and have

minimum skills in security work.

5.2. Training

5.2.1. A pharmacist should keep herself/himself abreast with

developments in pharmaceutical services, by:-

(a) reading current pharmaceutical literature

(b) attending necessary workshops and seminars
(c) further training in clinical pharmacy / pharmacy
practice
(d) doing first aid training
(e) being engaged in other forms of continuing education.

In addition, pharmacists should be aware of legislative

changes in the practice and be able to implement them.

44
 5.2.2. Auxiliary staff

Pharmacy manager / pharmacist must develop training

modules for all the staff in order to improve the level of
competence and correct deficiencies in day to day work.

Pharmacist / pharmacy manager responsible for training of

auxiliary staff:-

(a) must take into consideration level of education

(b) must do needs assessment for the planned training
(c) must provide training in hygiene, staff client
relationship, handling of medicines, dispensing, dress,
etc.

5.3. Management / Administration

The pharmacist must be the manager of every chemist / retail pharmacy.

He must own shares in the chemist not less than 51% or pharmacy must
be owned by pharmacist or corporate body of pharmacists.

This makes sit easier for him to take his stand against unethical practices
and undue influence from proprietor.

No pharmacy should run without a pharmacist. When a pharmacist

leaves, the pharmacy should be closed or locum pharmacist must be
employed immediately, i.e. LOCUM OR LOCK UP.

6.0. RELATIONSHIP WITH PATIENTS, PUBLIC AND OTHER HEALTH

PROFESSIONALS

6.1. Relationship with patients and public

In day to day operations, a pharmacist prime concern must be the

welfare of both patients and the public.

A pharmacist must keep confidential all patient information obtained in

the course of his duties, and can only reveal such information if and
when it is for the benefit of the patient.

6.2. Relationship with health care professionals

A pharmacist shall endeavour to co-operate with professional colleagues

and members of other health professions so that patients and public
benefit.

45
 PART D

STANDARDS FOR HOSPITAL PHARMACY

PREAMBLE

The hospital may be considered as the centre of health care in the community.
Bench-mark data, in fact demonstrate that the hospital is the “monument of the
failure of the health of the Community”.

In the diagnosis, prevention, alleviation or treatment of human disease, DRUGS

(MEDICINES) play a crucial role. Since drugs play such an important and
indispensable role in health care delivery:-

- they must be available

- they must be properly kept
- they must be efficiently distributed
- their quality, efficacy and safety must be assured
- they must be well controlled
- information about them must be readily available
- education about them must be continually updated and available
- they must be subject to frequent / continuous investigation and review

All matters pertaining to drugs must therefore efficiently and effectively be

managed by a department directed by a professionally competent and legally
qualified pharmacist supported by other suitably trained personnel – the
pharmacy department.

In order to be effective and relevant, the pharmacy department in the hospital

must be continually cognizant of the task of the team it belongs to – Health
Service, and of the part it is best qualified to pay – Pharmaceutical Service.

In order to fulfil its role, and perform its crucial task optimally the pharmacy
department must operate in accordance with standards of good hospital
pharmacy practice.

1.0. STANDARDS FOR PREMISES, EQUIPMENT AND FACILITIES

1.1. Premises means premises for hospital pharmacy departments.

Premises should be so designed, equipped and organised that they can

fulfil their essential role in the protection of public health i.e. should
comply with statutory requirements, be of sufficient size with adequate
facilities to provide the range of activities required of the pharmaceutical
services.

The premises and their contents must be in an area where there can be
securely locked to minimise burglary.

46
 Premises should be maintained in a good state of repair and precautions
should be taken to protect against the entrance and harbouring of
animals and birds, rodents, insect and other pests.

Storage space must be suitable for purpose intended e.g. flammables

stores, controlled drug cupboards.

All parts of premises should be maintained in a clean and tidy condition.

All parts of the premises should have suitable and effective means of
heating, lighting and ventilation.

All working surfaces, cupboard and shelves in the dispensary should be

finished with smooth, impervious and washable materials and maintained
in a good state of repair.

Working conditions must be so arranged as to protect the safety of the

public and people working on the premises.

External appearance of the hospital pharmacy must inspire confidence in

the nature of health care that can be provided.

1.2. Equipment

A pharmacist should satisfy himself that equipment in premises is

adequate and suitable for all the operations to be carried out.

All equipment should be kept clean and checked for cleanliness

prior to each use.

Except non-returnable containers, equipment must be of such material

and be kept in such good repair and condition as to enable it to be
thoroughly cleaned to prevent and risk of contamination. (Use of
stainless steel and glass is recommended, not enamelled iron or
plastics).

Equipment should include the following (minimum):-

(a) A dispensing bench of adequate size, having a smooth

impervious working top.

(b) Sink – with an adequate supply of hot and cold running

water

(c) A suitable means of counting tablets and capsules should be

taken to avoid cross contamination.

47
 (d) An accurate weighing scale and dispensing balance with
adequate range of weights, which are periodically calibrated
by an independent reputable source.

(e) Fire fighting equipment.

(f) A suitable range of graduated, stamped, glass measures.

(g) A refrigerator (temperature range 0 – 10 degrees

centigrade).

(h) Suitable means for sterilisation of medicinal products, if

prepared on the premises.

(i) A suitable range of tablets and capsules containers, also

liquid containers (and poisons container).

(j) A suitable range of labels should be available with the

foregoing containers.

(k) An adequate supply of spatulae should be available.

(l) Distillers (or at least distilled water for reconstitution)

especially in large hospitals and private hospitals.

1.3. Facilities

1.3.1. Toilet facilities should be appropriately located, designed

and equipped and should have hand washing facilities (with
a clearly legible notice requesting users to wash their hands
after using the toilet). In addition there should be hand –
drying facilities such as disposable towels or hand-driers.

1.3.2. Waste disposal

Communication system such as telephone, fax machine,

intercoms, and other facilities, which may enhance the
quality of the pharmaceutical service, expected.

2.0. STANDARD FOR SCOPE/RANGE OF SERVICE IN HOSPITALS

2.1. Range of services available from hospital services

- Vital and essential drugs as described by an Essential Drugs

list must be available to all wards and departments.

- Compilation of up-to-date formularies appropriate for local

needs.

48
 - Drugs information service.

- Pre-registration programme for pharmacy students.

- Manufacture of commonly used oral mixtures and some

topical preparations.

- Quality control

- Specialised services much as aseptic dispensing, clinical

pharmacy, maybe available in hospitals where there are
adequate financial resources and skilled manpower.

(a) Dispensing pharmacy ( in wards, theatre, OPD, etc)

response to:-

- needs of recipients of the service i.e. stock item

emergency trays, storage of items requiring
refrigeration, individual patient requests.

- frequent monitoring of prescribing habits, storage and

administration of drugs to ensure maximum safety of
the patient and cost of effectiveness of treatment.

- back-up service after main dispensary in closed.

- encourage patients and medical staff to report

adverse drug reactions, bad formulations of drugs and
good ones on the pharmaceutical services.

(b) Drug information

- must be comprehensive, independent, objective

- should be in easily accessible form i.e. easy to

retrieve information if there is a good filing and index
system.

- continuing education and imparting of this knowledge

to colleagues. Pharmacist must also listen to other
medical professionals’ views on pharmaceutical
services expected health care.

2.2. Standards expected

Hygiene and cleanliness i.e. methods of waste disposal for papers,

plastic, glass, contaminated or expired drugs, no smoking policy, no

49
 pests, no eating in dispensary, and any other practices that enhance
quality of pharmaceutical services.

GMP, good manufacturing practice, standards should be observed at all

times.

Good reference literature such as Codex (BPC)

Zambia National Formulary, Martindale the Extra Pharmacopoeia
MIMS Africa, BNF, must be included in budget every year. Onus is on
the pharmacists to check for recent publications from various sources.

- Generic names should be used in all aspects of drug

handling.

- Systematic training of students from schools of pharmacy

should cover all aspects of Pharmacy Practice.

Deliberate policy of continuing education programme for each practising

pharmacist should be in place.

Good dispensing practice, i.e. adequate, legible labelling in suitable

packing material, patient counselling on used and storage if necessary.

2.3. Measures to ensure control and accountability

A system of stock surveillance by pharmacist should be in place:-

- self audit system for each pharmacy of the standards

expected.

- failure to conform to (majority of) required standards should

warrant a penalty on the part of the personnel responsible
for the hospital pharmacy that is the pharmacist or the
pharmacy technician.

50
 PART E

STANDARDS FOR PROMOTION AND ADVERTISING OF MEDICINES

1.0. PROMOTION

1. (1) “Promotion” means all informational and persuasive activities by

manufacturers and distributors, the effect of which is to induce the
prescription, supply, purchase and/or use of Medicinal drugs.

1. (2) Active promotion within Zambia shall take place only with
respect to drugs legally available in the country. Promotion shall be in
keeping with national health policies and in compliance with national
regulations, as well as voluntary standards where they exist. All
promotion-making claims concerning medicinal drugs should be reliable,
accurate, truthful, informative, balanced up-to-date, capable of
substantiation and in good taste. The word “safe” shall only be used if
properly qualified. Comparison of products should be factual, fair and
capable of substantiation. Promotional material should not be designed
so as to disguise its real nature.

(3) Scientific data in the public domain shall be made available to

prescribers and any other person entitled to receive it, on request, as
appropriate to their requirements. Promotion is the form of financial or
material benefits should not be offered to or sought by health care
practitioners to influence them in the prescription of drugs.

(4) Scientific and educational activities shall not be deliberately used for
promotional purposes.

2.0. ADVERTISING

2. (1) Advertisements in all Forms to Physicians and Health-

related professional

(a) The wording and illustrations in advertisements to physicians and

related health professionals should be fully consistent with the
approved scientific data sheet for the drug concerned or other
source of information with similar content. The next shall be fully
legible.

(b) Advertisement shall contain full product information, as defined by

the approved scientific data sheet or similar documents for a given
period from the date of first promotion or for the full product life.
Advertisements that make a promotional claim shall at least contain
summary scientific information.

(c) Advertisements shall contain, among others:-

51
 (k) the name(s) of the active ingredient(s) using either
international non-proprietary names (INN) or the approved
generic name of the drug:

(ii) the brand name;

(iii) content of active ingredient(s) per dosage form or regimen;

(iv) name of other ingredients known to cause problems;

(v) approved therapeutic uses;

(vi) dosage form or regimen

(vii) side-effects and major adverse drug reactions

(viii) precautions, contra-indications and warnings;

(ix) major interactions;

(x) name and address of manufacturer or distributor;

(xi) reference to scientific literature as appropriate

(x) name and address of manufacturer, or distributor;

(xi) reference to scientific literature as appropriate

(d) Where advertisements are permitted without claims (reminders

advertisements), they shall include at least the branch name (if any)
the international non-proprietary name or approved generic name,
the name of each active ingredient, and the name and address of
the manufacturer or distributor for the purpose of receiving further
information.

2. (2) Advertisements in all forms to the general public

(a) Advertisements to the general public shall help people to make rational
decisions on the use of drugs determined to be legally available
without a prescription. While they shall take account of people’s
legitimate desire for information regarding their health, they shall not
take undue advantage of people’s concern for their health. They shall
not generally be permitted for prescription drugs or to promote drugs
for certain serious conditions that can be treated only by qualified
health practitioners, for which certain countries have established lists.
To fight drug addiction and dependency, scheduled narcotic and
psychotropic drugs should not be advertised to the general public.
While health education aimed at children is highly desirable, drug

52
 advertisement should not be directed at children. Advertisements may
claim that a drug can cure, prevent, or relieve an ailment only if this
can be substantiated. They should also indicate, where applicable,
appropriate limitations to the use of the drug.

(b) When lay language is used, the information should be consistent with
the approved scientific data sheet or other legally determined scientific
basis for approval. Language which brings about fear or distress
should not be used.

(c) Advertisements to the general public shall contain, taking into account
the media employed.

(i) the name(s) of the active ingredient(s) using either international

non-proprietary names (INN) or the approved generic name of the drug;

(ii) the brand name; (if any)

(iii) major indication(s) for use;

(iv) major precautions, contra-indications and warnings;

( v) name and address of manufacturer or distributor;

(vi) storage instructions;

(vii) expiry date

3. Medical representatives

(1) Medical representatives shall have an educational background.

They shall be adequately trained. They should possess
sufficient medical and technical knowledge and integrity to
present information on products and carry out other promotion
on products and carry out other promotional activities in an
accurate and responsible manner. Employers are responsible
for the basic and continuing training of their representatives.
Such training shall include instruction regarding appropriate
ethical conduct taking into consideration the WHO criteria. In
this context, exposure of medical representatives and trainees
to feed back form the medical and allied professions and from
independent members of the public, particularly regarding risks,
can be salutary.
(2) Medical representatives should make available to prescribers
and dispensers complete and unbiased information for each
product discussed, such as an approved scientific data sheet or
other source of information with similar content.

53
 (3) Employers should be responsible for the statements and
activities of their medical representatives should not offer
inducements to prescribers and dispensers. Prescribers and
dispensers should not solicit such inducements. In order to
avoid over promotion, the main part of the remuneration of
medical representatives should not be directly related to the
volume of sales they generate.

4. Free samples of prescription drugs for promotion purposes

Free samples of legally available prescription drugs may be provided in

modest quantities to prescribers, generally on request.

5. Free samples of non-prescription drugs to the general public for

promotional purposes

No free samples of any drugs (whether prescription or non prescription)

shall be given to the general public for promotional purposes.

6. Symposia and other scientific meetings

(1) The objective scientific content of symposia and scientific meetings

should be paramount, and presentations should be made by independent
scientists and health professionals wherever possible. Symposia and
scientific meetings should wherever possible be organised by scientific or
professional bodies.

(2) The fact of sponsorship by a pharmaceutical manufacturer or

distributor should be cleared stated in advance, at the meeting and in any
proceedings. The latter should accurately reflect the presentations and
discussions. Entertainment or other hospitality and any gifts offered to
members of the medical and allied professions, should be secondary to
the main purpose of the meeting and should be kept to a modest level.

(3) Any support to individual health practitioners to participate in any

domestic or international symposia should not be conditional upon any
obligation to promote any medicinal product.

7. Post-marketing scientific studies, surveillance and dissemination of

information

(1) Post-marketing clinical trials for approved medicinal drugs are important
to ensure their rational use. The Pharmacy & Poisons Board shall be
made ware of any such studies and that relevant scientific and ethical
committees shall conform the validity of the research.

Inter-country and regional co-operation in such studies may be useful.

Substantiated information on such studies shall be reported to the

54
 appropriate Pharmacy & Poisons Board and disseminated as soon as
possible.

(2) Post-marketing scientific studies and surveillance shall not be

misused as a disguise form of promotion.

(3) Substantiated information on hazards associated with medicinal drugs

shall be reported to the Pharmacy & Poisons Board as a priority and shall
be disseminated internationally as soon as possible.

8. Packaging and labelling

Appropriate information being important to ensure the rational use of

drugs, all packaging and labelling material shall provide information
consistent with that approved for product registration.

9. Information for patients: Package inserts, leaflets and booklets

(1) Adequate information on the use of medicinal drugs shall be made

available to patients. Such information shall be provided by physicians or
pharmacist whenever possible. When package inserts or leaflets used
shall reflect only the information that has been approved for product
registration. If package inserts or leaflets used for promotion purposes,
they shall comply with the standards enunciated herein. The wording of
the package inserts or leaflets, if prepared specifically for patients, shall
be in lay language on condition that the medical and scientific contents is
properly reflected.

(2) In addition to approved package inserts and leaflets wherever available,

the preparation and distribution of booklets and other
informational material for patients and consumers shall be encouraged
as appropriate. Such material shall also comply with the standards
enunciated herein.

10. Promotion and exported drugs

Ethical criteria for the promotion of exported drugs shall be identical with
those relating to drugs for domestic use.

55
 PART F

REGULATORY AFFAIRS

PREAMBLE

The Thalidomide disaster of 1961 awakened the developed world to the need for
systematic and effective Pharmaceutical Regulation.

In recent years unscrupulous companies have taken advantage of the

weaknesses of Pharmaceutical Regulatory Systems in developing countries
(including Zambia) and have frequently damped substandard and counterfeit
medicines on the market of these countries.

In the light of these developments it has become an accepted axiom that a sound
Pharmaceutical Regulatory (Quality Assurance) System is part and parcel of any
reliable Pharmaceutical supply system. “The Pharmaceutical market is no place
for blind faith”.

All manufacturers and importers of pharmaceutical products are basically

responsible for the quality, efficacy and safety of the products they manufacture
or import.

All pharmaceutical practitioners are responsible for the quality of pharmaceutical

services they render. However, governments of the world have realised
assurance of quality, safety, and efficacy off pharmaceutical products
(medicines) cannot be left to the good sense of the industry alone. Therefore,
the Ministry of Health has a responsibility to monitor all pharmaceutical practices
and services, as other health services, to ensure that such practices and services
are in the best interest of public health and the individual patient.

In Zambia the role of monitoring pharmaceutical manufacturing, importation,

distribution and trade/supply has been largely delegated to the Pharmacy and
Poisons Board. The Pharmacy and Poisons Board is appointed by the Ministry
of Health. The Board in turn appoints a Registrar and Inspectors.

The Pharmacy & Poisons Board was established by an Act of Parliament (Cap.
536).

The Secretariat of the Pharmacy and Poisons Board is provided by the

designated staff of the Department of Pharmaceutical Services. The Board and
the Secretariat constitutes the Pharmaceutical Regulatory Authority.

The role of a Pharmaceutical Regulatory Authority is to ensure that

pharmaceutical products and their accompanying information which are made
available for distribution / use meet agreed standards for quality, efficacy and
safety throughout the chain of manufacture / importation, distribution and sale /
supply.

56
Pharmaceutical Practitioners and all those engaged in Pharmaceutical
manufacturing, importation, wholesale dealing and retail trade have a
responsibility to be aware of and abide by the laws and regulations which control
these practices and services.

The main acts which control Medicines, Pharmacy and Poisons are The
Pharmacy and Poisons Act. The Therapeutic Substances Act and the
Dangerous Drugs Act.

The Pharmacy & Poisons Act establishes the Pharmacy and Poisons Act
regulates the trade in medicines and poisons. The Therapeutic Substances Act
regulates those medicines which if not used without proper safeguard could be
injurious to public health (e.g. antibiotics) or / and those which required special
controls (e.g. biological assays) to establish their potency. The Dangerous Drugs
Act controls these drugs which are subject to abuse (such as narcotics). These
three Acts, (The Pharmacy & Poisons Act, the Therapeutic Substances Act and
the Dangerous Drugs Act) are administered by the Pharmacy and Poisons
Board. Other relevant acts are the Medical and Allied Professions Act and the
Food and Drugs Act.

The Medical and Allied Professions Act provides for the registration of
Pharmacists (and Pharmacy Technicians) Medical Practitioners, Dentists and
Allied Professions; and establishes the Medical Council which administers this
Act.

The Food and Drugs Act establishes the Food and Drugs Board and is meant to
protect the public against health hazards and fraud in the sale and use of food,
drugs, cosmetics and medical devices.

All these Acts require revision and updating so as to make them enforceable and
relevant to current practices.

Efforts are being made to revise and update legislation in Pharmacy, Medicines
and Poisons to:-

- make better provision for the regulation of the pharmaceutical profession;

- ensure that medicines are manufactured, imported, handled, stores and

used in such a way that the patient receives the maximum benefit;

- bring the control of poisons up-to date; and

- provide for related matters.

Before any new legislation is enacted, the current legislation, of course, remains
in force.
The Pharmacy and Poisons Act, for instance, empowers the Minister of Health to
make rules (by statutory instrument(s) to regulate, among other things, the
manufacture, importation, distribution and sale of medicines and poisons.

57
1. Pharmaceutical registration and licensing

Pharmaceutical licensing is pivotal to any effective system of

pharmaceutical regulation. By defining conditions and terms of licensing,
delineation of the authorised form the unauthorised / the acceptable from
the unacceptable from the unacceptable is established; and thus the
licensing system lays the basis for the other arms of pharmaceutical
regulatory control ( the inspectorate and (technical aspects of) quality
control).

In Zambia Statutory Instrument number 46 of 1993 stipulates the licences

required for various types of Pharmaceutical practices; these are:-

(i) Licence to manufacture medicines

(ii) Licence to import medicines
(iii) Pharmaceutical product licence
(iv) Pharmaceutical wholesale dealer’s licence
(v) Registration of Retail Pharmacy; and
(vi) Licence to sell Part 2 poisons.

The stages of the licences are also stated as:-

Application for a licence

(i) Application for a licence

(ii) Issue of the licence; and
(iii) Annual retention fee of the licence

A pharmaceutical licence is granted only after the Regulatory Authority is

satisfied that the applicant meets minimum standards and has subsequently paid
the required licence fees. Each licence is renewable annually upon payment of
an annual retention fee and a satisfactory annual inspection report.

1.1. Pharmaceutical product licence / registration

(a) Pharmaceutical registration often refers to the process of evaluating a

pharmaceutical product by competent health authorities for the
purpose of determining the suitability of that product for placement on
the market. The process culminates in the issuance of a product
licence. A product licence is a legal document which establishes:-

- detailed composition and formulation of a pharmaceutical

product

- pharmacopoeal or other officially recognised specifications of its

ingredients

- its clinical inter-changeability (for multi-source products /

58
 generics)

- packaging

- shelf-life

- labelling / accompanying information

The basic criteria for any pharmaceutical product to be registered in

Zambia are QUALITY, SAFETY AND EFFICACY.

(b) Statutory Instrument number 47 of 1993 stipulates the information that

should accompany an application for a product licence, that is to say:-

(i) Name and address of applicant

(ii) Name of medicine
(iii) Dosage form of medicine
(iv) Active constuents of medicine
(v) Indications and methods of use
(vi) Contraindications, warnings and precautions
(vii) Composition
(viii) Shelf life
(ix) Containers and packaging
(x) Labelling
(xi) Method of sale, that is to say whether it is to be by:-
- Prescription Sale Only
- Pharmacy Sale Only; or
- General Sale
(xii) Manufacturer’s name and address
(xiii) Distributors’ name and address
(xiv) WHO Certificate of quality and free sale
(xv) Name and designation of person signing the application
(xvi) Any other information which may be requested by the Board

(c ) Additional information requested has often been with regard to:-

- Quality specifications;
- Quality control;
- Stability studies data;
- Bio-availability data;
- Methods of manufacture and analysis;
- A typical batch certificate of analysis.

(d) When the medicine to be imported or manufactured is to be marketed

in Zambia for the first time, the following information must also include:-

(i) the Chemistry of the medicine

(ii) the Pharmacological data

59
 (iii) the toxicological data
(iv) the teratology
(v) the clinical studies; and
(vi) the countries in which the sale of the medicines has been
authorised

The statutory Instrument (number 47 of 1993) should be consulted for

detail.

(e) The terms of the product licence are legally binding and, therefore,
the licence holder or / and his declared distributor / representative
has responsibility to ensure that the product and its accompanying
information is only manufactured / imported and distributed in
accordance with the information submitted to the competent
authorities for registration / licensing purposes.

(f) Advertising and promotion of medicines

Every package or container of a medicine (except medicines dispensed

by a pharmacist in a registered pharmacy) should be labelled to show:-

(i) The name of the medicine

(ii) the Pharmacological properties
(iii) the names and quantities of active ingredients
(iv) the quantity of the medicine
(v) the directions for use
(vi) the contra-indications, warnings and precautions
(vii) the storage instructions
(viii) the expiry date
(ix) the batch number
(x) the date of manufacture
(xi) the licence number
(xii) the name and address of manufacturer(s)
(xiii) the method of sale, that is to say, whether by:-

- Prescription Only
- Pharmacy Sale Only or
- General Sale

Statutory Instrument number 47 of 1993 should be consulted for

details on labelling.

(h) Dispensed Medicines

Every package or container of dispensed medicines should be labelled to

indicate:-

(i) The name of the person to whom the medicines is to be

administered

60
 (ii) The dosage or where the medicine is to be used

(iii) The date on which the medicines is dispensed

(vi) Any other information necessary to ensure the correct

use of the medicine

(v) Name and address of supplier of the medicine

(i) Sale of medicine

(i) pharmacies (or authorised / licensed sellers / suppliers of

medicines) may sell by retail or otherwise supply medicines –
providing that general sale medicines may be sold in a place
other than a Pharmacy.

(ii) a general sale medicine is sold in a place other than a

Pharmacy it must be sold in the original package labelled with:-

- full instructions for use

- contra-indications, warnings and precautions; and
- the package must be conspicuously marked with the l letters “G.S.”
for general sale

Statutory Instrument number 47 of 1993 should be consulted for

other details on the sale of medicines

1.2. Pharmaceutical Manufacturer’s licence

(a) The basic requirements for a Pharmaceutical Manufacturer’s

licence are:-

(i) suitable premises, facilities and equipment for proper

Pharmaceutical Production and Quality Control

(ii) Suitably qualified personnel for supervision of production

(iii) Suitably qualified personnel for supervision of quality control

(iv) A duly registered pharmacist

(v) Suitable arrangements, documentation, programmes and

systems for good Pharmaceutical manufacturing practice

Minimum standards of good manufacturing practice are

described in Part A of “Standards or Pharmaceutical practice
(for Zambia)”.

61
 (b) The terms of the Pharmaceutical Licence are that the manufacturer
(licence holder) undertakes:-

(i) to conform to good manufacturing practices for

Pharmaceuticals as recommended by the World Health
Organisation (and endorsed by the Regulatory Authority in
Zambia)
(ii) to cause the registration in Zambia of all such products as
are manufactured by the said manufacturer;
(iii) to conform to such other standards as shall be endorsed by
the Licensing Authority;
(iv) to accept inspections of the manufacturing premises
conducted by the Pharmaceutical Inspectors appointed by
the Regulatory Authority, at any time;
(v) to pay to the licensing Authority such relevant fees as shall
be prescribed.

(c ) Information to accompany an application for a pharmaceutical

manufacturer’s license should include:-

(i) Name and address of business (that is to say: street, plot /

stand numbers, P O Box, town / city).

(ii)Name and qualifications of person(s) in charge of production;

(iii) Name and qualifications of person(s) in-charge of quality

control;

(iv) Name of company pharmacist / pharmacist in-charge;

(v) Brief comments on range of dosage forms to be manufactured;

(vi) Brief comments on manufacturing and quality control

facilities;
(vii) Copy of certificate of incorporation
(viii) Name and designation of person signing the application;
(ix) An application fee.

1.3. Pharmaceutical Import Licence

(a) The basic requirements for a Pharmaceutical import licence are:-

(i) Suitable premises, facilities and equipment for proper

Pharmaceutical warehousing;
(ii) suitably qualified (pharmaceutical) personnel;
(iii) suitable arrangements, programmes and systems for
procurement, storage, documentation, stock surveillance
and distribution.

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 (b) The terms of a Pharmaceutical import licence are that the importer
(licence holder) undertakes:-

(i) to conform to good Pharmaceutical import practices;

(ii) to ensure that all such products as are imported are
authorised for marketing/distribution in Zambia in
accordance with Statutory Instrument number 47 of 1993
and in conformity with the World Health Organisation
Scheme on the Quality of Pharmaceutical products in
International Commerce;
(iii) to observe such other standards of practice as shall be
endorsed by the Pharmacy and Poisons Board; and
(iv) to pay such fees as shall be prescribed.

(c ) Information accompanying an application for a Pharmaceutical Import

Licence should include:-

(i) Name and address (that is to say; street, plot/stand number, P

O Box, town / city);
(ii) Name of pharmacist, evidence of full registration of the
pharmacist, terms of employment and letters of agreement;
(iii) name of pharmacy technician, evidence of registration of the
pharmacy technician, terms of employment and letters of
agreement;
(v) copy of certificate of incorporation of the company;
(vi) name and designation of person signing the application;
(vii) application fee.

1.4. Pharmaceutical wholesale dealer’s licence

(a) The basic requirements for a pharmaceutical wholesale dealer’s

licence are similar to those described under pharmaceutical import
licence (1.3.(a) above).
(b) The terms of the pharmaceutical wholesale dealer’s licence are that
the licence holder (wholesale dealer) undertakes:

(i) To conform to good pharmaceutical warehousing and

wholesale dealing practice;

(ii) to observe regulations and such other standards of practice

as shall be endorsed by the Regulatory Authority;
(iii) to accept the inspections conducted by the inspectors
appointed by the Regulatory Authority at any time;
(iv) to pay the relevant fees.

(c) The information required to accompany an application for a

Pharmaceutical wholesale dealer’s licence is similar to that
described under Pharmaceutical Import Licence (1.3 (c ) above).

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1.5. Certificate of retail pharmacy registration

(a) The basic requirements for a certificate of Retail Pharmacy

Registration are:-

(i) Suitable premises, facilities and equipment for properly

pharmacy business;
(ii) A duly registered pharmacist;
(iii) Suitable arrangements and working systems to assure
effective, safe and efficient pharmaceutical service to the
community.

(b) The terms of certificate of Retail Pharmacy Registration are that the
directors and management of the Retail Pharmacy undertake:-

(i) To ensure that the Retail Pharmacy business shall be under

the personal control and management of a duly registered
pharmacist;
(ii) To observe good Pharmacy practice
(iii) To conform to such other standards of practice as shall be
endorsed by the Regulatory Authority;
(iv) To accept inspections conducted by inspectors appointed by
the Regulatory Authority at any time;
(v) To pay the relevant fees.

(c) Information required to accompany an application for registration of

a retail pharmacy includes:-

(i) Name and address of business (that is to say: street, plot /

stand number, P O Box, town / city;
(ii) Name of full-time Pharmacist and evidence of full registration
of the Pharmacist, terms of employment and letter of
agreement;
(iii) Copy of Certificate of incorporation;
(iv) Name and address of person signing the application;
(v) Application fee.

1.6. Licence to sell Part 2 Poisons

(a) Part 2 Poisons are those which appear on the list of Part 2 Poisons.
In determining Part 2 Poisons, regard is made of those articles /
substances “which are in common use, or likely to come into
common use, for purposes other than the treatment of human
ailments, use, or likely to come into common use, for purposes
other than the treatment of human ailments, and which it is
reasonably necessary to include therein if the public are to have
adequate facilities for obtaining them”. Thus, by definition, Part 2

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 Poisons are NOT human medicines. The list includes certain
chemicals, pesticides and others.
(b) The Licensing Authority for Part 2 Poisons is the Provincial Medical
Officer of the area in which the business in Part 2 Poisons is to be
conducted.
(c) The Licensing Authority issues a Licence to deal in Part 2 Poisons,
if the said Authority is satisfied that:-

(i) The applicant is a fit and proper person to sell Poisons in

Part 2 of the Poisons List;

(ii) The premises in which he proposes to carry on such

business are suitable;

(iii) The applicant has paid the prescribed fee.

(d) An applicant for a licence to sell Part 2 Poisons should include:-

(i) Name of applicant and

(ii) Address of premises

1.7. Obligations of licence holders, refusal to grant licence and

revocation of a licence

(a) Every Licence holder has an obligation to observe the terms of

each licence and to inform the Regulatory / Licensing Authority of
any charges which may affect the terms of licence.
(b) The Regulatory / Licensing Authority may refuse to issue a licence
or may revoke a Licence of any person who in the opinion of the
Authority is, for sufficient reason relating either to himself
personally, his premises or other terms of Licence, not fit to be
Licensed.

In the event of such refusal or revocation, an appeal lies to the

Regulatory Authority (The Pharmacy and Poisons Board) whose decision
is final.

2. PHARMACEUTICAL INSPECTORATE

(a) The basic role of the Pharmaceutical inspectorate is to ensure that

the terms of Licence are observed by Licence holders at all times.
(b) Thus the Pharmaceutical Inspectorate has to ensure that
Pharmaceutical products are manufactured / imported, distributed
and supplied / sold in accordance with the terms and conditions set
out in the product Licence;
(c) The inspectorate has to establish, through periodic formal
inspections and spot checks, that all Licence holders operate within
the terms of their Licences and observe other prescribed

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 regulations and officially recognised standards of practice, that is to
say:-

(i) that Pharmaceutical manufacturers comply with good

manufacturing practice;
(ii) that Pharmaceutical importers observe good Pharmaceutical
import and warehousing practice;
(iii) that pharmaceutical wholesale dealers observe good
Pharmaceutical warehousing and wholesaling practices;
(iv) that Retail Pharmacies observe good Pharmacy practices;
(v) that hospital Pharmacies observe good hospital Pharmacy
practice.

3.0. QUALITY CONTROL FACILITIES

(a) All Pharmaceutical manufacturers should have sufficient facilities

for the effective quality control of the products they manufacture in
Zambia.
(b) All importers of Pharmaceutical products should have reliable and
effective arrangements for monitoring the quality of the products
they import into Zambia.

In addition each imported batch should be accompanied by a satisfactory

certificate of batch analysis.

(c) Batch records of Pharmaceutical products manufactured or

imported into Zambia must be made accessible to Pharmaceutical
Inspectors at any time / on demand.
(d) In addition to its own (independent) National Quality control
Laboratory facilities, the Pharmaceutical Regulatory Authority may
accredit certain laboratories whose results of analysis shall
represent the officially recognised findings.
(e) The National Quality Control Laboratory and any other accredited
Laboratory (ies) shall observe Good Laboratory Practice at all
times.

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