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
 
4.1 Quality surveillance during manufacture

The inspection of manufacturing facilities is required to ensure that good manufacturing practices are followed at all times. In assessing manufacture, the inspector is required to pay particular attention to raw materials, manufacturing procedures, sterile operations, packaging and labelling, in-process quality control, personnel and storage facilities. Special attention should be paid to any alterations of the master formula and manufacturing procedures.

An additional mechanism of drug quality surveillance at the time of manufacture is the batch control (batch certification) of some types of drugs. According to this procedure each batch of a drug, after being declared by the manufacturer as fully conforming to quality specifications, is “put in quarantine” while a random sample is taken and analysed by a governmental drug control laboratory for confirmation of its quality. The batch is released only after a satisfactory result is obtained. Such a mechanism, which calls for a duplication of the manufacturer’s control efforts by the governmental authorities, is usually restricted to specific types of drugs, such as those that are potent but highly labile. It is usually phased out once the quality level of manufacture is considered sufficiently uniform by the drug control agency.

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