Originally promugulated in 1969 and revised in 1975. Main objectives were :

  • Guidelines be developed for official inspections of drug manufacturing facilities
  • To assess compliance of GMP

WHO GMP requirements have been developed taking into account the principles in various GMP texts and also considering the requirements of developing countries. These requirements are not for domestic use but for international trade.
GMP Requirements
  1. Quality Management
  2. Sanitation and hygiene
  3. Validation
  4. Complaints and recalls
  5. Contract production and analysis
  6. Self Inspection
  7. Personnel
  8. Premises
  9. Equipment
  10. Materials
  11. Documentation
  12. Sterile production
  13. Active pharmaceutical ingredients
WHO GMP ensures the following:
    • Avoidance of Cross- Contamination
    • Prevention of Mix-ups
    • Provide Traceability
    • Accountability of actions
    • Responsibility
    • Product Performance Guarantee
For certification details please contact: