Storage of pharmaceutical products

1. Storage of Pharmaceutical Products
Dr. Basavaraj K. NanjwadeM. Pharm., Ph. D
Department of Pharmaceutics
Faculty of Pharmacy
Omer Al-Mukhtar University
Tobruk, Libya.
E-mail: nanjwadebk@gmail.com
2014/06/15 1
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.

2. CONTENTS
1. Good storage practices (GSP).
2. Materials requiring special storage.
3. Reference.
2014/06/15 2
Faculty of Pharmacy, Omer Al-Mukhtar
University, Tobruk, Libya.

3. Good storage practical
(GSP)
1. Introduction
2. Glossary
3. Personnel
4. Premises and facilities
5. Storage requirements
6. Returned goods
7. Dispatch and transport
8. Product recall
2014/06/15 3
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.

4. 1.Introduction
• The guidelines are applicable not only to
manufacturers of medicinal products but also to
pharmaceutical importers, contractors and
wholesalers, and community and hospital pharmacies.
• They should be adjusted in line with the type of
activity where the storage of pharmaceuticals is
taking place. National or regional regulations should
be followed for all related activities.
2014/06/15
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
4

5. 2. Glossary
• Active pharmaceutical ingredient (API)
• Contamination
• Cross-contamination
• Excipient
• Expiry date
• Labelling
• Manufacture
2014/06/15
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
5

6. • Material
• Packaging material
• Pharmaceutical product
• Production
• Retest date
• Storage
• Supplier
2014/06/15
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
6
2. Glossary

7. 3. Personnel
• 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.
2014/06/15
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
7

8. 4. Premises and facilities
• Storage areas: Precautions must be taken to prevent
unauthorized persons from entering storage areas.
• 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. Equipment used for monitoring should also
be calibrated at defined intervals.
2014/06/15
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
8

9. 5. Storage requirements
• Documentation: written instructions and records
• Labelling and containers
• Receipt of incoming materials and pharmaceutical
products
• Stock rotation and control
• Control of obsolete and outdated materials and
pharmaceutical products
2014/06/15
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
9

10. 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 re-evaluation.
• 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.
2014/06/15
Faculty of Pharmacy, Omer Al-Mukhtar
University, Tobruk, Libya.
10

11. 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.
• The date of dispatch;
• The customer’s name and address;
• The product description, e.g. name, dosage form and
strength (if appropriate), batch number and quantify;
• The transport and storage conditions.
• All records should be readily accessible and available
on request.
2014/06/15
Faculty of Pharmacy, Omer Al-Mukhtar
University, Tobruk, Libya.
11

12. 8. Product recall
• There should be a procedure to recall from the
market, promptly and effectively, pharmaceutical
products and materials known or suspected to be
defective.
2014/06/15
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
12

13. Materials requiring
special storage
• Intravenous medicines stored in minibags and when
frozen can be very fragile, hence great care must be
observed when handling
• Storage requirements for IV (Intravenous) doses must be
carefully considered.
• If medicines require refrigeration, a designated
refrigerator should be set aside in the pharmacy.
• CIVA (Centralized Intravenous Additive Service) doses should
be stored there until they are transported to the wards,
where they should be refrigerated until required.
2014/06/15 13
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.

14. • Refrigerators used in hospital pharmacies are
pharmaceutical grade refrigerators.
• They should have a temperature recorder and should
be fitted with an alarm to alert pharmacy staff to any
changes in storage conditions.
• Refrigerators used at a ward level should also be
carefully monitored to ensure that adequate storage
conditions are achieved.
• All refrigerated CIVA doses should be allowed to
reach room temperature prior to administration to the
patient.
2014/06/15
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
14
Materials requiring
special storage

15. THANK YOUe-mail: nanjwadebk@gmail.com
2014/06/15 15
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.