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
3.1 Manufacturers

As stated in Good Practices in the Manufacture and Quality Control of Drugs (4), it is the responsibility of manufacturers to ensure the quality of the drugs they produce. Similarly, they have the responsibility to develop appropriate dosage forms (including packaging) that are adequately stable under climatic conditions prevailing in the country or countries in which the preparations are intended to be used.

The manufacturer must establish the shelf-life of the product in relation to recommended storage conditions by using an appropriate stability-testing programme. Full details of the work carried out to establish the shelf-life should be made available to drug regulatory authorities. The expiry date and recommended storage conditions must be communicated to all involved in the pharmaceutical supply system and to patients; it is recommended that this information should be given on the label. When necessary, the utilization period must be determined and additionally specified on the label.

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