(1997; 248 pages) [French]
The head of the laboratory, and the heads of the various subunits in larger establishments, should be of high professional standing and have had extensive previous experience in drug analysis and laboratory management in a quality control laboratory in the regulatory sector or in industry. Non-supervisory analysts should be graduates in pharmacy, analytical chemistry, microbiology, or other relevant subjects. Technical staff should preferably hold diplomas in their subjects from technical or vocational schools.
The head of the laboratory must be satisfied that all key members of the laboratory staff have the requisite competence and are given grades matching their responsibilities. To encourage them in carrying out their tasks, all staff should be made aware of the important contribution of drug control to public health. In many countries, national regulations prohibit staff from holding independent posts or consultant assignments.
To reduce the possibility of human error, supervisors should periodically arrange for standard samples to be analysed and, where called for, review the adequacy of existing staffing, management, and training procedures. Error is most likely to occur during non-instrumental operations, and particularly in preparatory work, from carelessness, fatigue, boredom, inadequate training or, sometimes, as a result of staff being given work beyond their level of competence. “Self-checking” procedures should be devised for instrument operators. Regular in-service training programmes should be arranged to update and extend the skills of both professionals and technicians. This not only keeps staff abreast of advances in analytical methods and instrumentation, but also provides opportunities for career development and promotion.
In large laboratories the staffing of the various units should be based not only on their workloads but also on the technical demands of the work involved. In most instances the ratio of technicians to analysts should be 1:3 in a chemical or physicochemical unit, and 2:5 in a biological or microbiological laboratory. The greater the proportion of routine analyses undertaken on products that, a priori, are not expected to be substandard, the greater the proportion of technicians that can be effectively employed. Non-routine work, and particularly the review of test methods for newly registered drugs, requires a higher proportion of fully qualified analysts.