(1997; 248 pages) [French]
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.