(2003; 148 pages)
Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status, which constitutes one of the elements of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. It may also be used as training material for government drug inspectors, as well as for production, quality control and quality assurance personnel in the industry.
The guide is applicable to operations for the manufacture of drugs in their finished dosage forms, including large-scale processes in hospitals and the preparation of supplies for use in clinical trials.
The good practices outlined below are to be considered general guides1, and they may be adapted to meet individual needs. The equivalence of alternative approaches to quality assurance, however, should be validated. The guide as a whole does not cover safety aspects for the personnel engaged in manufacture or environmental protection: these are normally governed by national legislation. A new concept of hazard analysis related to the risks in production and personnel safety is also newly recommeded (Annex 7). The manufacturer should assure the safety of workers and take the necessary measures to prevent pollution of the external environment. International Nonproprietary Names (INNs) for pharmaceutical substances designated by WHO should be used when available, together with other designated names.
1 The word “should” in the text means a strong recommendation.