Transcription of Annex 1 WHO good practices for pharmaceutical quality ...
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Annex 1 WHO good practices for pharmaceutical quality ...
81 World Health OrganizationWHO Technical Report Series, No. 957, 2010 Annex 1 WHO good practices for pharmaceutical quality control laboratoriesGeneral 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.
manufacture of a pharmaceutical dosage form and that, when so used, becomes an active ingredient of that pharmaceutical dosage form. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body (1).
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