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
Close this folderNational laboratories for drug quality surveillance and control1
View the document1. Introduction
View the document2. First-stage laboratory for drug surveillance
Open this folder and view contents3. Medium-size drug control laboratory
View the document4. Scope of activity
View the document5. Factors influencing the size and location of a laboratory
Open this folder and view contents6. Implementation of control laboratory projects
Open this folder and view contentsGood laboratory practices in governmental drug control laboratories1
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

4. Scope of activity

The principal responsibilities are as follows:

- to establish, by testing, whether a given sample of a drug, either locally manufactured or imported, conforms to required specifications and whether packaging is adequate;

- to examine pharmaceutical products suspected to be of questionable efficacy or safety, and to demonstrate and document any evidence of deterioration, contamination, or adulteration;

- to check the stability of products under local conditions of storage.

Other responsibilities that may devolve upon the laboratory include:

- evaluating data supplied by manufacturers concerning product performance;

- determining whether the product label provides appropriate and clear instructions for use;

- advising on planned purchases of drugs within the public sector.

These additional activities require qualified staff and library facilities. However, since they are not directly dependent on the use of laboratory facilities, the necessary resources have not been taken into consideration within this annex.

In developed countries, drug-licensing regulations require an independent examination of data supplied by the manufacturer in support of an application for registration of a product. The required pharmaceutical data are detailed in Annex 5 to the twenty-fifth report of the WHO Expert Committee on

Specifications for Pharmaceutical Preparations.1 When resources are available for such work, review and verification of these data by critical examination of pertinent quality specifications may be included among the responsibilities of a large drug control laboratory or it may be undertaken in a separate laboratory associated with the regulatory authority. No provision for these activities has been made in the laboratories described in sections 2 and 3.

1 WHO Technical Report Series, No. 567, 1975.

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