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
Open this folder and view contents2. Product assessment and registration
Close this folder3. Distribution
Close this folderQuality assurance in pharmaceutical supply systems1
View the document1. Introduction and general considerations
Open this folder and view contents2. Elements of quality assessment and assurance
Open this folder and view contents3. Pre-marketing quality assessment
Close this folder4. Drug quality surveillance during marketing
View the document4.1 Quality surveillance during manufacture
View the document4.2 Quality surveillance of imported drugs
View the document4.3 Quality surveillance during distribution
View the documentReferences
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

4. Drug quality surveillance during marketing

Quality surveillance during marketing is an integral function of a drug control agency. It is undertaken by monitoring and auditing procedures involving both inspection and laboratory testing.

The places in which drugs are manufactured, stored and distributed should be known to the control authorities. This information can be obtained by requiring all manufacturers, importers and distributors to give the control authorities official notification of their planned activities before they commence operations, and to comply with any particular regulations.

Drug quality surveillance is facilitated if lists of nonproprietary names are established for all pharmaceutical substances on the market in a country, with references to trade names where applicable.

To aid the application of procedures for the recall of pharmaceutical products, it might be useful if the control authorities had knowledge of the persons responsible for marketing in each manufacturing enterprise, as well as information about the distribution mechanism and the destination of the products.

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