Good Manufacturing Practices For Quality Control

3. Good Manufacturing Practices (GMP) 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

4. Good Manufacturing Practices (GMP) 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

5. Good Manufacturing Practices (GMP) 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

6. Good Practices for Quality Control Laboratories (GPQCL) 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. Premises 8. Equipment, instruments and other devices

7. Good Practices for Quality Control Laboratories (GPQCL) Part Two. Materials and set-up of equipment, instruments and other devices 9. Specifications archive 10. Reagents 11. Reference materials 12. Calibration, validation and verification of equipment, instruments and other devices 13. Traceability

8. GPQCL Part Three. Working procedures 14. Incoming sample 15. Analytical worksheet 16. Testing 17. Evaluation of test results 18. Retained samples Part Four. Safety in pharmaceutical control laboratories 19. General rules