Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Open this folder and view contentsIntroduction
Open this folder and view contents1. National drug regulation
Close this folder2. Product assessment and registration
View the documentGuidelines for the assessment of herbal medicines1,2
Close this folderStability of drug dosage forms1
View the document1. Introduction
View the document2. General considerations
Close this folder3. Responsibility of parties involved in the assurance of drug stability
View the document3.1 Manufacturers
View the document3.2 Drug regulatory authorities
View the document3.3 Procurement agencies
View the document3.4 Pharmacists and other workers in the supply system
View the document4. Use of terms
View the document5. Less stable drug substances
View the documentReferences
Open this folder and view contentsGuidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms1
Open this folder and view contentsMultisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability1
Open this folder and view contents3. Distribution
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Open this folder and view contents6. Laboratory services
Open this folder and view contents7. International trade in pharmaceuticals
Open this folder and view contents8. Counterfeit products
Open this folder and view contents9. Training
View the documentSelected WHO publications of related interest
View the documentBack cover
3.4 Pharmacists and other workers in the supply system

Normally the supply system should be under the direct control of a pharmacist. When this is not possible, the responsible person should be under pharmaceutical supervision and have adequate training.

The responsible person should ensure that:

(a) Older stock is dispensed first and attention is paid to the expiry dates.

(b) Products are stored according to the recommended storage conditions, as stated on the label, etc.

(c) Products are observed for evidence of instability.1

1 General requirements for drug dosage forms will be published in The international pharmacopoeia.

(d) Products that are repackaged or further processed are properly handled and labelled.

(e) Products are dispensed in the proper containers with the proper closures.

(f) Patients are educated and informed concerning the proper storage and use of the products, including the disposal of outdated or excessively aged prescriptions.

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