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
Close this folder3. Medium-size drug control laboratory
View the document3.1 Capability
View the document3.2 Premises
View the document3.3 Staff
View the document3.4 Equipment
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
 
3.3 Staff

The staffing complement comprises 14-18 persons, including the head of the laboratory, 4-5 analysts, 6-8 laboratory technicians, and 2-4 supporting and housekeeping staff. The ratio of analysts to laboratory technicians must be relatively high in a laboratory carrying out analyses on a wide range of pharmaceutical products. The ratio may be reduced in laboratories involved in repetitive testing of batches of a limited number of products.

The head of the laboratory should be a graduate in pharmacy or chemistry, preferably with a postgraduate degree in pharmaceutical analysis or related subjects and with broad practical experience in the many facets of drug quality assessment. The analysts should be graduates in pharmacy, analytical chemistry, biochemistry, or microbiology, as appropriate to their assigned responsibilities. An institutional training for the technicians is desirable, otherwise provision must be made for in-service training in the laboratory. High ethical standards are mandatory for the head of the laboratory and the analysts.

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