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
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
Close this folder6. Laboratory services
Open this folder and view contentsNational laboratories for drug quality surveillance and control1
Close this folderGood laboratory practices in governmental drug control laboratories1
View the document1. General
Close this folder2. Management and operational issues
View the document2.1 Organizational structure
View the document2.2 Staffing
View the document2.3 Incoming samples
View the document2.4 Analytical worksheet
View the document2.5 Testing
View the document2.6 Evaluation of test results
View the document2.7 Retention samples
View the document2.8 Specifications repertory
View the document2.9 Reagents
View the document2.10 Reference materials
View the document2.11 Instruments and their calibration
View the document2.12 Safety in drug control laboratories
View the documentReferences
Open this folder and view contentsSampling procedure for industrially manufactured pharmaceuticals1
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
2.8 Specifications repertory

Every drug control laboratory must possess the current versions of all the specifications that it needs, whether they are contained in pharmacopoeial compendia or in manufacturers’ registration documents. In a large laboratory the specifications repertory is a documentation service with responsibility for updating all the pharmacopoeias - including supplements, addenda, and corrections - used in the laboratory and maintaining a specifications file for all drugs marketed within the country.

The repertory should retain a list of all pharmacopoeias in the laboratory and ensure that adequate numbers of supplements and addenda are ordered. All updatings and corrections should be noted in the principal volumes to prevent obsolete sections being used. Additional or replacement pages for loose-leaf publications should be inserted immediately they are received; pages no longer valid should be removed.

In addition, every laboratory should maintain a file of non-pharmacopoeial quality specifications for drugs tested to specifications established either by the manufacturer or by the laboratory itself. The range of monographs in this file will depend on current legal requirements and on whether or not a published national or regional pharmacopoeia is accorded official status within the country. Each entry should be numbered and dated so that the latest revision can easily be seen. The copy in the repertory file should bear the date of approval by the national registration authority or the lead unit and any other information relevant to the status of the monograph. All subsequent corrections or changes should be entered in these copies and endorsed with the date and the initials of the person making the entry. The master copy should never be released from the repertory; for laboratory use photocopies should be taken.

Manufacturer’s specifications are the property of the company and in some countries are made available to governments strictly for registration purposes. In this case the quality control laboratory may need to negotiate their release with manufacturers or even, in some cases, to develop independent specifications. In other countries national laboratories are routinely asked to give their opinion on the specifications for each newly introduced product when it is registered by the drug regulatory authority.

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