(1997; 248 pages) [French]
The capacity of a drug regulatory authority to undertake quality surveillance is directly related to the operational capability of the associated national quality control laboratories. The results of laboratory assessment of samples of marketed drugs permit the regulatory authority to evaluate the actual quality of products used in the country and to identify the problem areas. When no independent analytical service is available to the regulatory authority, judgements on the quality of drugs must be based largely on data supplied by manufacturers or importers, which are inherently difficult to challenge.
The importance of a drug control laboratory to the implementation of surveillance as an element of quality assurance in pharmaceutical supply systems has been stressed in Annex 1 of the twenty-seventh report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations.2 Developing countries are particularly vulnerable to the supply of substandard drugs and, where no testing facilities exist, such problems can be particularly acute. This annex therefore examines the principles that should determine the structure and management of a national drug quality control laboratory where no such facility yet exists.
2 WHO Technical Report Series, No. 645, 1980.
National authorities have the option of establishing either a central laboratory or a number of smaller laboratories dispersed throughout the country. Even the existence of a single small laboratory, when it is concerned with priority issues and perceptively managed, can offer a deterrent against unscrupulous or negligent manufacturing and trading practices. It is also evident that standards of local manufacturers will tend to rise whenever the possibility of an independent assessment of the quality of their products exists.
The laboratory would at least have the potential to detect products, both raw materials and dosage forms, that have been mislabelled, and to detect adulterated and spurious products. Its capacity to undertake full analyses of products to check their conformity with labelled specifications would be severely limited. Clear priorities would therefore need to be set to ensure that attention is concentrated upon products that are of prime importance to public health programmes, or that are potentially dangerous, unstable, or unusually expensive.
The advice contained in the following paragraphs applies to the organization and staffing of two model laboratories, one of medium size and the other providing minimum facilities for efficient work. The latter is designated as a first-stage laboratory for drug surveillance. Although provision is made for some types of biological testing by the laboratories described here, they are not equipped for the testing of sera and vaccines. No consideration is given to larger-scale drug control laboratories, haying regard to the limited resources available for such purposes in most developing countries.
Matters concerning the management and operation of drug control laboratories do not fall within the scope of these recommendations; these aspects will be the subject of a separate WHO document.