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
Open this folder and view contentsNational laboratories for drug quality surveillance and control1
Close this folderGood laboratory practices in governmental drug control laboratories1
View the document1. General
Close this folder2. Management and operational issues
View the document2.1 Organizational structure
View the document2.2 Staffing
View the document2.3 Incoming samples
View the document2.4 Analytical worksheet
View the document2.5 Testing
View the document2.6 Evaluation of test results
View the document2.7 Retention samples
View the document2.8 Specifications repertory
View the document2.9 Reagents
View the document2.10 Reference materials
View the document2.11 Instruments and their calibration
View the document2.12 Safety in drug control laboratories
View the documentReferences
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
2.2 Staffing

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.

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