ABSTRACT
The WHO provides GMP guidelines and also offers a program of GMP compliance certification. To assure that the interpretation of the WHO guidelines is properly understood, an appendix to this guideline includes the glossary of terms used. To achieve the quality objective reliably, there must be a comprehensively designed and correctly implemented system of quality assurance incorporating GMP and quality control. The purpose of self-inspection is to evaluate the manufacturer’s compliance with GMP in all aspects of production and quality control. The self-inspection program should be designed to detect any shortcomings in the implementation of GMP and to recommend the necessary corrective actions. All recommendations for corrective action should be implemented. The procedure for self-inspection should be documented, and there should be an effective follow-up program. Good documentation is an essential part of the quality assurance system and, as such, should exist for all aspects of GMP.
