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

5. Factors influencing the size and location of a laboratory

Many considerations determine the location, size, and organization of a national control laboratory. They include: financial resources; the drug control requirements of the national regulatory authority; the extent of drug usage within the country; and the number of different sources from which products are purchased.

If a country has a decentralized national administrative structure or if communications are poor, it may be necessary to establish provincial or peripheral laboratories.

Careful consideration must also be accorded to organizational and professional links between the control laboratory and other public health services, including food control laboratories, microbiological laboratories, hospital or regional clinical laboratories, and university departments of medicine or pharmacy.

Although it is practicable to institute and run a medium-size control laboratory apart from other laboratory services, economies can be effected by siting it in a complex together with other institutions. This enables the laboratory to retain independence of operation, while sharing common supporting services (e.g. supply units, maintenance crews, and repair shops). It also offers the possibility of using specialized facilities in adjacent laboratories (e.g. bacteriological laboratories for sterility testing) instead of duplicating the same facilities within the drug control laboratory.

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