OMS-Bonnes pratiques de fabrication: principes généraux

The guide is applicable to operations for the manufacture of medicines in their fi nished 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, and they may be adapted to meet individual needs. The equivalence ofalternative approaches to QA, however, should be validated. The guideas a whole does not cover safety aspects for the personnel engaged in manufacture or environmental protection: these are normally governed by national legislation.