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
3.2 Drug regulatory authorities

Drug regulatory authorities must request adequate stability data from manufacturers in support of their claims concerning the shelf-life of registered products relevant to their countries. These data must be evaluated in the light of scientific knowledge and experience.

They should develop means to ensure that relevant information on shelf-life and storage conditions is readily available to all concerned, for example by establishing regulations on labelling. They should ensure, when inspections of manufacturing establishments are carried out in accordance with the requirements of Good Practices in the Manufacture and Quality Control of Drugs (4), that appropriate stability-testing programmes for marketed products are being followed.

Guidelines and inspections are necessary to ensure that drug products are adequately handled and stored in the pharmaceutical supply system - for example, by requiring that the temperature regimen recommended by the manufacturer is followed, that there is appropriate control of other environmental factors, that a proper system of stock rotation (“first-in-first-out” rule) is maintained, and that expired products are destroyed. More detailed consideration of such factors is to be found in publications by FIP and IFPMA (7) and others (8, 9). The importance of adequate storage facilities cannot be overemphasized. Experience in many countries proves that investment in warehouses is cost-effective. Products should be monitored by random visual inspection and where possible by laboratory testing at various stages in the distribution system (including hospital wards).

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