WHO defines Good Manufacturing Practices (GMP) as "that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization."
GMP covers all aspects of the manufacturing process including :
- Defined manufacturing process
- Validated critical manufacturing steps
- Suitable premises, storage, transport, qualified and trained production and quality control personnel
- Adequate laboratory facilities
- Approved written procedures and instructions
- Records to show all steps of defined procedures have been taken
- Full traceability of a product through batch records and distribution records
- Systems for recall and investigation of complaints
