GOOD STORAGE PRACTICES FOR PHARMACEUTICALS AS PER WHO AND NMPB GUIDELINES)

Proper storage of crude materials, in process material or finished product is a necessity in pharmaceutics
to ensure safety, efficacy and quality of the finished products. Without proper storage conditions any
medicine can lose its potency and thus efficacy will be lost. Herbal medicine has been used
therapeutically all around the world, being an important aspect of various traditional medicine system.
So WHO has taken steps in assessment of quality, safety and efficacy of medicinal plants thus storage,
packing and handling of herbs for various Ayurvedic dosage forms is an important aspect. So
manufacturing units, pharmaceutical importers, contractors and wholesalers, and community or
hospital pharmacies must comply with the guidelines suggested by WHO. The guidelines are as follows

1. Introduction

This guide is intended for those involved in the storage, transportation and distribution of
pharmaceuticals. It is closely linked to other existing guides recommended by the WHO Expert
Committee on Specifications for Pharmaceutical Preparations, such as:

 Good trade and distribution practice (GTDP) of pharmaceutical starting materials

 The stability testing of pharmaceutical products containing well established drug substances in
conventional dosage forms

 Good manufacturing practices (GMP)

 The International Pharmacopoeia.

2. Objective

 To describe the special measures considered appropriate for the storage and transportation of
pharmaceuticals.

3. Personnel

 At each storage site, there should be adequate number of qualified personnel to achieve
pharmaceutical quality assurance objectives. National regulations on qualifications should be
followed.

 All personnel should receive proper training in relation to good storage practice, regulations,
procedures and safety.

 All members of staff should be trained in, and observe high levels of personal hygiene and
sanitation.
 Personnel employed in storage areas should wear suitable protective or working garments
appropriate for the activities they perform

4. Premises and Facilities

Storage Areas

 Precautions must be taken to prevent unauthorized persons from entering storage areas

 Storage areas should be of sufficient capacity to allow the orderly storage of the various categories
of materials and products, namely starting and packaging materials, intermediates, bulk and
finished products, products in quarantine and released, rejected, returned or recalled products.

 Storage areas should be clean and dry and maintained within acceptable temperature limits.

 Materials and pharmaceutical products should be stored off the floor and suitably spaced to permit
cleaning and inspection.

 Pallets should be kept in a good state of cleanliness and repair.

 Storage areas should be clean, and free from accumulated waste and vermin. A written sanitation
programme should be available indicating the frequency of cleaning, the methods to be used and
also for pest control. The pest-control agents used should be safe, and there should be no risk of
contamination of the material and pharmaceutical products.

 Receiving and dispatch bays should protect materials and products from the weather. Reception
areas should be designed and equipped to allow cleaning of incoming materials and pharmaceutical
products, if necessary, before storage

 Where quarantine status is ensured by storage in separate areas, these areas must be clearly
marked and their access restricted to authorized personnel. Any system replacing physical
quarantine should provide equivalent security. Fox example, computerized systems can be used,
provided that they are validated to demonstrate security of access.

 There should normally be a separate sampling area for starting materials in a controlled
environment.

 Physical or other equivalent validated (eg. electronic) segregation should be provided for the
storage of rejected, expired, recalled or returned materials or products. The materials or products,
and areas concerned should be appropriately identified.

 Highly active and radioactive materials, narcotics and other hazardous, sensitive and or dangerous
materials and pharmaceutical products, as well as substances presenting special risks of abuse, fire
or explosion, (e.g, combustible liquids and solids and pressurized gases) should be stored in a
dedicated area with additional safety and security measures.
 Materials and pharmaceutical products should be handled and distributed according to GMP
guidelines

 Materials and pharmaceutical products should be handled and stored in such a manner as to
prevent contamination, mix-ups and cross-contamination.

 Materials and pharmaceutical products should be stored in conditions which assure that their
quality is maintained, and stock should be appropriately rotated. The "first expired first out" (FEFO)
principle should be followed.

 Rejected materials and pharmaceutical products should be identified and controlled under a
quarantine system designed to prevent their use until a final decision is taken on their fate.

 Narcotic drugs should be stored in compliance with international conventions, and national laws
and regulations on narcotics.

 Broken or damaged items should be withdrawn from usable stock and separated.

 Storage areas should provide adequate lighting to enable all operations to be carried out accurately
and safely

Storage Conditions

 Storage conditions for pharmaceutical products and materials should be in compliance with the
labelling, which is based on the results of stability testing

Monitoring of Storage Conditions

 Recorded temperature monitoring data should be available for review.

 All monitoring records should be kept for atleast the shelf-life of the stored material or product plus
I year, or as required by national legislation.

 Equipment used for monitoring should be checked and calibrated at defined intervals and the
results of such checks should be recorded and retained.

5. Storage Requirements

Documentation: Written Instructions and Records

 Written instructions and records should be available which document all activities in the storage
areas including the handling of expired stock, storage procedures, route of materials and
pharmaceutical products and information through the organization in the event of a product recall
being required.

 Permanent information, written or electronic, should exist for each stored material or product
indicating recommended storage conditions, any precautions to be observed and retest dates.
 Pharmacopoeial requirements and current national regulations concerning labels and containers
should be respected at all times.

 Records should be kept for each delivery. They should include the description of the goods, quality,
quantity, supplier, supplier's batch number, the date of receipt, assigned batch number and the
expiry date. Such records should be retained for a period equal to the shelf life of the incoming
materials and products, where applicable, plus 1 year or as specified by national regulations.

 Comprehensive records should be maintained showing all receipts and issues of materials and
pharmaceutical products according to a specified system, [Link] batch number.

Labelling and Containers

 All materials and pharmaceutical products should be stored in containers which do not adversely
affect the quality of the materials or products concerned, and which offer adequate protection
from external influences.

 All containers should be clearly labelled with at least the name of the material, the batch number,
the expiry date or retest date, the specified storage conditions and reference to the pharmacopoeia,
where applicable. Unauthorized abbreviations, names or codes should not be used.

Receipt of Incoming Materials and Pharmaceutical Products

 On receipt, each incoming delivery should be checked against the relevant purchase order and each
container physically verified, eg by the label description, batch number, type of material or
pharmaceutical product and quantity

 The consignment should be examined for uniformity of the containers and, if necessary, should be
subdivided according to the supplier batch number.

 Each container should be carefully inspected for possible contamination, tampering and damage,
and any suspect containers or, if necessary, the entire delivery should be quarantined for further
investigation.

 When required, samples should be taken only by appropriately trained and qualified personnel and
in strict accordance with written sampling instructions. Containers from which samples have been
taken should be labelled accordingly.

 Following sampling, the goods should be subject to quarantine. Batch segregation should be
maintained during quarantine and all subsequent storage.

 Materials and pharmaceutical products should remain quarantine until authorized release or
rejection is obtained.

 Measures should be taken to ensure that rejected materials and pharmaceutical products cannot
be used. They should be stored separately while awaiting destruction or return to the supplier.
Stock Rotation and Control

 Periodic stock reconciliation should be performed by comparing the actual and recorded stocks.

 All significant stock discrepancies should be investigated as a check against inadvertent mix-ups
and/or incorrect issue.

 In manufacturing facilities, partly used containers of materials and pharmaceutical products should
be securely reclosed and resealed to prevent spoilage and or contamination during subsequent
storage. Materials and pharmaceutical products from containers which have been opened or partly
used should be used up before those in unopened container.

 Damaged containers should not be issued unless the quality of the material has been shown to be
unaffected. Where possible, this should be brought to the attention of the person responsible for
quality control. Any action taken should be documented.

Control of Obsolete and Outdated Materials and Pharmaceutical Products

 All stocks should be checked regularly for obsolete and out-dated materials and pharmceutical
products. All due precautions should be observed to prevent their issue.

6. Returned Goods

 Returned goods, including recalled goods, should be handled in accordance with approved
procedures and records should be maintained.

 All returned goods should be placed in quarantine and returned to saleable stock only after this has
been approved by a nominated, responsible person following a satisfactory quality reevaluation

 Any stock reissued should be so identified and recorded in stock records. Pharmaceuticals returned
from patients to the pharmacy should not be taken back as stock, but should be destroyed.

7. Dispatch and Transport

 Materials and pharmaceutical products should be transported in such a way that their integrity is
not impaired and that storage conditions are maintained.

 Special care should be exercised when using dry ice in cold chains. It must be ensured that the
material or product does not come in into contact with dry ice, as this may adversely affect the
product quality, eg by freezing

 Where appropriate, the use of devices to monitor conditions such as temperature during
transportation is recommended. Monitoring records should be available for review.
 The dispatch and transport of materials and pharmaceutical products should be carried out only
after receipt of a delivery order. The receipt of the delivery order and the dispatch of the goods
must be documented.

 Dispatch procedures should be established and documented, taking into account the nature of the
materials and pharmaceutical products concerned and any special precautions that might be
required.

 The outside container should offer adequate protection from all external influences and should be
indelibly and clearly labelled.

 Records for dispatch should be retained stating at least:

- the date of dispatch

- the customer's name and address

- the product description, eg. name, dosage form and strength (if appropriate), batch number and
quantity

- the transport and storage conditions.

 All records should be readily accessible and available on request.

8. Product Recall

 There should be a procedure to recall pharmaceutical products and materials from the market,
promptly and effectively, if known or suspected to be defective.

Appendix

Storage and labelling condition

a) Normal storage conditions

Storage in dry, well-ventilated premises at temperatures of 15-25 0C or, depending on climatic

conditions, up to 30°C. Extraneous odours, other indications of contamination, and intense light must be
excluded.

b) Defined storage instructions

Drug products that must be stored under defined conditions require appropriate storage instructions.
Unless otherwise specifically stated (eg. continuous maintenance of cold storage) deviation may be
tolerated only during short-term interruptions, for example, during local transportation

The use of the following labelling instructions are recommended:

“Do not store over 30 0C" means store between +2 0C to +30 0C

"Do not store over 25 "C" - from +2 °C to +25 C

“Do not store over 15 0C from +2 0C TO +15 0C

“Do not store over 8 0C” from +2 C to 8 0C

"Do not store below 8 0C “from +8 C to +25 C

"Protect from moisture no more than 60% relative humidity in normal storage conditions, to be
provided to the patient in a moisture-resistant container

"Protect from light" to be provided to the patient in a light-resistant container

STORAGE OF MEDICINAL PLANT PRODUCE

(As per Guidelines on Good Field Collection Practices for Indian Medicinal Plants
National Medicinal Plants Board Department of AYUSH, Ministry of Health and Family Welfare
Govt. of India in Collaboration with WHO Country Office for India, New Delhi, 2009)

Following storage recommendations may be adopted, which will help protect the quality of the
medicinal plant produce during storage.
 Medicinal plant produce should be stored in a dedicated storehouse, constructed in such away
as to avoid entry of rodents, birds and other animals and should be free from dampness, dirt
and dust. Medicinal plant produce should never be stored in open areas and in or near cattle
sheds.
 The storehouse should have provision for keeping approved, rejected and untested lots
separately with appropriate signboards.
 Properly sealed and labeled containers of medicinal plant produce should be kept preferably on
wooden pallets, at cool and dry places. Never stack the containers, especially gunny bags, jute
bags, woven sacks, corrugated box etc. directly on the floor.
 Dedicated areas for each species should be clearly earmarked and enough space should be left
between two species and different parts of same species to ensure smooth movement of
persons and machine and to avoid any cross-contamination. Containers of two or more
medicinal plant produces should never be stacked one above the other.
 Each lot of the produce should have its shelf life clearly marked on its label and the produce
should be used within the valid shelf life period. In case of traders, the supplies of the produce
should be done in a way so as to allow enough shelf life period to the manufacturers. To the
greatest possible extent, the medicinal plant produce should be supplied/consumed on FIFO
 (First in first out) basis to minimize storage of old stock. FIFO system allows sequential use of
produce, in order of the arrivals in the storehouse. Documentation of produce coming in and
going out should be displayed at an appropriate place to know the exact availability of the
medicinal plant produce in stock.
 There should be provision for separate climate (temperature and humidity) controlled facility to
store hygroscopic material and volatile material.
 Inflammable produce like resins, gum-resins, oils etc. should be stored at isolated place in closed
containers (flammable materials should be clearly labeled as such on each container)