81 World Health Organization who technical Report Series, No. 957, 2010



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81
© World Health Organization
WHO Technical Report Series, Nob

Annex 1
WHO good practices for pharmaceutical
quality control laboratories
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, verifi cation of performance and qualifi cation 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. Certifi cate of analysis
20. Retained samples Part four. Safety General rules References
Appendix
Equipment fora rst-stage and medium-sized pharmaceutical quality control laboratory
TRS957.indd 81 21.04.10 11:03



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