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
3.3 Procurement agencies

Procurement agencies should require sufficient information on the composition, the process of manufacture, stability, and provisions for appropriate labelling to be included in the drug procurement documents. Where possible, this information should be checked against data provided for registration purposes. In cases where the date of manufacture is not indicated on the label of a product, this information should be given in the accompanying documentation. In addition, the procurement agencies should inform potential suppliers of any extreme environmental conditions that might prevail.

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