WHO Good Practices For Pharmaceutical QC Laboratories

WHO Good Practices For Pharmaceutical Quality Control Laboratories

Annex 1

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TABLE OF CONTENTS

General considerations

Glossary

Part one. Management and infrastructure

1. Organization and management

2. Quality management system

3. Control of documentation

4. Records

5. Data-processing equipment

6. Personnel

7. Premises

8. Equipment, instruments and other devices

9. Contracts

Part two. Materials, equipment, instruments and other devices

10. Reagents

11. Reference substances and reference materials

12. Calibration, verification of performance and

qualification of equipment, instruments and other devices

13. Traceability

Part three. Working procedures

14. Incoming samples

15. Analytical worksheet

16. Validation of analytical procedures

17. Testing

18. Evaluation of test results

19. Certificate of analysis

20. Retained samples

Part four. Safety

21. General rules

References

Appendix

Equipment for a first-stage and medium-sized pharmaceutical quality control laboratory

WHO Good Practices For Pharmaceutical Quality Control Laboratories