WHO GMP For Pharmaceutical Products: General Considerations


WHO Good Manufacturing Practices (GMP) For Pharmaceutical Products: Main Principles

General Considerations:

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 medicines inspectors, as well as for production, QC and QA personnel in the industry.

The guide is applicable to operations for the manufacture of medicines 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 guides,2 and they may be adapted to meet individual needs. The equivalence of alternative approaches to QA, 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 has also been recently recommended (WHO Technical Report Series, No. 961, 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 (INN) for pharmaceutical substances designated by WHO should be used when available, together with other designated names.

WHO Good Manufacturing Practices For Pharmaceutical Products: Main Principles

(Annex 2, WHO Technical Report Series 986, 2014)

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