WHO TRS (Technical Report Series) 957, 2010 Annex 1


WHO TRS (Technical Report Series) 957, 2010 Annex 1

WHO good practices for pharmaceutical quality control laboratories

General considerations:

The WHO Expert Committee on Specifications for Pharmaceutical Products adopted in 1999 the guidelines entitled WHO Good practices for national pharmaceutical control laboratories, which were published as Annex 3 of the WHO Technical Report Series, No. 902, 2002. As the other guidelines related to laboratory quality assurance have been updated and subsequent inspections for the compliance with the guidelines on good practices for national pharmaceutical control laboratories indicated that some sections were in need of improvement and clarification, it was considered necessary to prepare a revised text.

These guidelines provide advice on the quality management system within which the analysis of active pharmaceutical ingredients (APIs), excipients and pharmaceutical products should be performed to demonstrate that reliable results are obtained.

Compliance with the recommendations provided in these guidelines will help promote international harmonization of laboratory practices and will facilitate cooperation among laboratories and mutual recognition of results.

Special attention should be given to ensure the correct and efficient functioning of the laboratory. Planning and future budgets should ensure that the necessary resources are available inter alia for the maintenance of the laboratory, as well as for an appropriate infrastructure and energy supply. Means and procedures should be in place (in case of possible supply problems) to ensure that the laboratory can continue its activities.

These guidelines are applicable to any pharmaceutical quality control laboratory, be it national, commercial or nongovernmental. However, they do not include guidance for those laboratories involved in the testing of biological products, e.g. vaccines and blood products. Separate guidance for such laboratories is available.

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Table of contents

General considerations


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


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

WHO TRS (Technical Report Series) 957, 2010 Annex 1:

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