Quality Systems Requirements for National Good Manufacturing Practice Inspectorates. WHO Technical Report Series 902, 2002, Annex 8
(2002; 18 pages)


Following the provisional guidelines on the inspection of pharmaceutical manufacturers, the WHO Expert Committee on Specifications for Pharmaceutical Preparations acknowledged that additional guidelines concerning national inspectorates would be of value in strengthening the implementation of good manufacturing practices (GMP) and enhancing mutual recognition among inspectorates.

A trend has recently become apparent in WHO Member States for non-commercial institutions, such as certification bodies, testing laboratories, etc., to introduce quality systems principles in their internal operations. The same principles are also being applied by governmental pharmaceutical inspectorates and drug control laboratories.

These requirements are applicable to quality systems for the operation of inspection services within competent authorities concerned with GMP inspections. It is intended that each inspection service should use these requirements as the basis for developing its own quality system. The establishment and operation of a quality system is an essential element in the mutual recognition of national GMP inspections. The willingness to accept national inspections is significantly enhanced when it is known that the GMP inspectorate of the competent authority follows uniform procedures incorporating quality system principles. The quality system should include all the activities involved in the inspection.

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