Storage of Pharmaceutical Products Dr. Basavaraj K. Nanjwade M. Pharm., Ph. D Department of Pharmaceutics Faculty of Pharmacy Omer Al-Mukhtar University Tobruk, Libya /06/151 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

CONTENTS 1.Good storage practices (GSP). 2.Materials requiring special storage. 3.Reference. 2014/06/152 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

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 2014/06/153 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

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

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

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

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

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

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

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

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

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

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. 2014/06/1513 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

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

THANK YOU /06/1515 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.