PHARMDOS LAB: PHARMACUTICAL MOD SEM
DOSAGE FORMS, DRUG DELIVERY 2 1
MODULE 2.1: CGMP & CGCP
CGMP d. compounding pharmacies/pharmacists may advertise or
• current good manufacturing practice otherwise promote the fact that they provide
CGCP prescription compounding services; however, they shall
• current good compounding practice not solicit business (e.g., promote, advertise, or use
salespersons) to compound specific drug products
REGULATORY ASPECTS OF CGMP e. distribution of large amounts of compounded products
• among the guidelines promulgated by the US-FDA without a prescriber/patient/pharmacist relationship is
Administrative Order no. 220 s. 1974 on current good considered manufacturing
manufacturing practice made the strongest impact on
the drug and cosmetic industry MAIN OBJECTIVE OF CGMP
• this administrative order was patterned after the a. SAFE
guidelines developed in 1963 by the US-FDA with the → unable to cause damage, free danger
participation of drug components b. PURE
→ freedom from contamination
GOOD MANUFACTURING PRACTICES (GMP) c. EFFECTIVE
• quality control → producing the desired effect
• production control
A. CONTAMINATION
FUNCTIONS OF THE QUALITY CONTROL IN THE GMP non compliance to CGMP could result in the following:
a. to audit/to inspect periodically the procedures, → quality variation
equipment, and facilities employed by the various areas → contamination (from people and environment)
engaged in research, development, production, control, → mix-ups and error
purchasing, distribution sale of the product → product recalls
b. to detect non compliance to CGMP and to correct them
DISADVANTAGES OF PRODUCT RECALL
MANUFACTURING a. causes financial losses
• production, preparation, propagation, compounding b. bad publicity that might damage the good reputation of
processing of a drug or other substance or device the company
• packaging or repackaging of such substance or device c. harmful publicity which can have a negative effect on
• the labeling or relabeling of the commercial container of sales
such substance or device
• but does not include the activities of a practitioner who CONTAMINATION SOURCES PREVENTION
has an incident to his or her administration or dispensing PARTICULATE a. unclean a. always wear
such substance or device in the course of his or her clothing clean clothing
professional practice, prepares, compounds, packages, and uniform
or labels such substance or device b. clothes that
shed lint and b. avoid wearing
particles clothes that
COMPOUNDING
shed lint or
• shall be the act of combining two or more ingredients in c. objects falling particles.
the preparation of a prescription out of one’s wear head
pocket coverings,
COMPONENT gloves, facial
• any ingredient intended for use in the compounding of a d. not following hair covering,
drug product, including those that may not appear in SOP’s masks,
such product protective
gear
COMPOUNDED DRUG PRODUCTS (PHARMACIST)
a. based on the existence of a c. do not use
breast pocket
pharmacist/patient/prescriber relationship and the
presentation of a valid prescription
d. follow SOP’s
b. pharmacists may compound drugs in very limited that relate to
quantities proper
c. pharmacists shall not offer compounded drug products cleaning of
to other persons or commercial entities for subsequent equipment
resale, except in the course of professional practice for a
practitioner to administer to an individual patient
GIANNA ALEXIS LINGAD 1
CROSS a. airborne e. keep • adequate locker facilities, hot and cold washing facilities
CONTAMINATION particles containers (including soap, air-dryer, single-serve towels), clean
within storage tightly closed toilet facilities near working areas
area and thru and in • adequate supply of potable water under continuous
ventilation separate positive pressure, plumbing system free from defects or
system
contamination
f. follow the
• suitable housing space for the care of all laboratory
b. packaging specific SOP’s
machines not on cleaning animals
cleared out equipment • safe and sanitary disposal of sewage, trash, and other
prior to a new and proper refuse within and from the buildings and immediate
packaging run labelling and premises
packaging
c. improper procedures D. EQUIPMENT
dispensing of • maintained in a clean and orderly manner
components g. follow SOP’s • suitable design, size, construction and location in
on correct relation to surroundings to facilitate maintenance and
d. inaccuracies dispensing of
operation for its intended uses
and mix-ups in components
record-keeping • suitable design, size, construction and location in
h. follow SOP’s in relation to surroundings to facilitate maintenance and
accurate operation for its intended uses
record- the equipment should have the following. properties:
keeping a. its surface should not be reactive, additive or absorptive
MICROBIAL a. people a. good personal so as to alter the properties of drug or cosmetic
b. SOPs not hygiene, b. it should prevent any substance required for its
being report all operation, (such as lubricants or colorants) come in
followed injuries and contact with the product
c. environment illnesses c. it should facilitate adjustments, dis-assembly, cleaning
and maintenance as necessary to ensure the reliability
b. follow SOPs
of control procedures, uniformity of production, and
on handling
exclusion of the product from contaminants from
storage,
cleaning and previous and current operations.
sterilization d. it should be suitable type, size and accuracy intended for
testing, measuring, mixing, weighing or other processing
c. monitor or storage operations
microbial level
of entries in the equipment logbook should contain the following:
environment a. date when the equipment was used
b. name of the product where the equipment was used
B. PERSONNEL c. date when it was cleaned
the qualified personnel should possess the following: d. personnel responsible for cleaning it
a. proper education e. date when the equipment was validated
b. proper training and experience to execute technological f. result of validation
assignments
ADMINISTRATIVE ORDER NO. 220 S1974
PERSONNEL HAVING DIRECT CONTACT WITH DRUGS AND • CGMP in manufacture, processing, packaging and
COSMETICS SHOULD: holding
→ periodic health check-ups
→ free from contamination diseases and open lesions on THE SCOPE OF THIS REGULATION IS AS FOLLOWS:
the exposed surface of the body a. definitions
→ have an awareness of the importance of good personal b. CGMP
hygiene c. buildings equipment personnel
→ wear clean outer garments d. components (raw materials)
→ maintain a high degree of personal cleanliness e. master formula and batch production records
→ should conform to hygienic practices f. production and control procedures
g. product containers packaging and labelling
C. BUILDINGS h. laboratory controls
• adequate space for proper operation of manufacturing, i. finished goods warehouse distribution records
processing, packaging, control and storage of products j. stability
and their components k. complaint files
• adequate lighting and ventilation
• facilities for adequate air-pressure, microbial/dust COMPLAINT RECORDS
screening, filtering, humidity/temperature controls to complaint records should contain the following:
minimize contamination of products a. name and address of the complainant
b. product name, strength, and control/lot number
c. nature of complaint function of the body of man or
d. reply to the person complaining other animals
e. results of the investigation and follow-up action that was F. INACTIVE • means any substance other
required INGREDIENT than “active ingredient”
if an investigation took place, the record must indicate: present in a drug
→ why it was considered unnecessary G. MATERIALS • means an organizational
→ the name of the person responsible for that decision APPROVAL UNIT element having the authority
and responsibility to approve
or reject raw materials, in-
PRESERVATION: SAMPLES AND RECORDS
process materials, packaging
FDA recommends the following retention periods:
components, and final products
H. STRENGTH means:
FOR COMPONENTS I - the concentration of known active
• at least 2 years after the distribution of the last of the drug substance in formulation
product incorporating the component has been example:
completed or; → /w, w/v, or unit dose
• one year after the expiration date of thus last lot /volume basis) and/or
incorporating the component
II - potency, that is, the specific
FOR FINISHED PRODUCTS ability or capacity of the product as
indicated by appropriate
• at least 2 years after lot distribution is completed or;
laboratory tests or by adequately
• one year after the expiration date of the product.
controlled clinical data obtained
FOR RECORDS: through the administration of the
DRUGS: same as above product in the manner intended to
COSMETICS: at least 3 years after the manufacture is completed effect a given result (s) expressed, for
example, in terms of units by
ADMINISTRATIVE ORDER NO. 220 S 1974 reference to a standard)
• current good manufacturing practice in manufacture,
processing, packaging or holding
A. COMPONENT • (raw material)
• means any ingredient intended
for use in the manufacturing of
drugs, including those that may
not appear in the finished
product
B. BATCH • means a specific homogenous
quantity of a drug or in case of
drug produced according to
single manufacturing order
during the same cycle of
manufacture
C. LOT • means a batch or any portion
of batch of a drug produced by
a continuous process, an
amount of drug produced in a
unit of time or quantity in a
manner that assures its
uniformity and in either case
which is identified by a
distinctive lot number and has
uniform character and quality
within specified limits
D. LOT NUMBER or • means any distinctive
CONTROL NUMBER combination of letters or
numbers, both, by which the
complete history of the
manufacture, control,
packaging and distribution of a
batch or lot of a drug is
determined
E. ACTIVE • means any substance of a
INGREDIENT which is intended to furnish
pharmacological activity or
other effect in the diagnosis,
cure, mitigation, treatment, or
prevention of disease or to
affect the structure or any
