Good Manufacturing Practices.ppt

Program Guidelines and references Good Manufacturing Practices (GMP) Good Manufacturing Practices (GMP) Good Manufacturing Practices (GMP) Good Practices for Quality Control Laboratories (GPQCL) Good Practices for Quality Control Laboratories (GPQCL) GPQCL Good Manufacturing Practices (GMP) Good Manufacturing Practices (GMP) (GMP) - QC (GMP) - QC (GMP) - QC (GMP) - QC (GMP) - QC (GMP) - QC (GMP) - QC (GMP) - QC (GMP) - QC (GMP) - QC (GMP) - QC (GMP) - QC (GMP) - QC (GMP) - QC (GMP) - QC (GMP) - QC (GMP) - QC (GMP) - QC * * Good Manufacturing Practices Guilin, PRC Dr AJ van Zyl for Quality Assurance and Safety: Medicines Medicines Policy and Standards Health Technology and Pharmaceuticals Cluster World Health Organization Good Manufacturing Practices Presentation on GMP (Production focus) Presentation on GMP (QC focus) Product specific focus Group session GMP: World Health Organization WHO Technical Report Series, No. 908, 2003, Annex 4. Good Manufacturing Practices for pharmaceutical products: main principles WHO Technical Report Series, No. Annex 3. WHO Technical Report Series, No. Annex 3. Introduction General considerations Glossary 1. Quality assurance 2. Good manufacturing practices for pharmaceutical products (GMP) 3. Sanitation and hygiene 4. Qualification and validation 5. Complaints 6. Product recalls 7. Contract production and analysis 8. Self-inspection and quality audits 9. Personnel 10. Training 11. Personal hygiene 12. Premises Quality control areas 13. Equipment 14. Materials Reagents and culture media Reference standards 15. Documentation 16. Good practices in production 17. Good practices in quality control Control of starting materials and intermediate, bulk and finished products Test requirements Batch record review Stability studies Part One. Management and infrastructure 1. Organization and management 2. Quality system 3. Control of documentation 4. Records 5. Data processing equipment 6. Personnel 7. Prem