(1997; 248 pages) [French]
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.