WHO Good Practices For Pharmaceutical Microbiology Lab

Sathyanarayana M.Sc.

WHO Good Practices Guidelines For Pharmaceutical Microbiology Laboratories

Annex 2

Click on the any titles below for complete guidelines


Introduction and scope of document


1. Personnel

2. Environment

2.1 Premises

2.2 Environmental monitoring in the laboratory

2.3 Cleaning, disinfection and hygiene

2.4 Sterility test facilities

3. Validation of test methods

4. Equipment

4.1 Maintenance of equipment

4.2 Qualification

4.3 Calibration, performance verification and monitoring of use

5. Reagents and culture media

5.1 Reagents

5.2 Media

5.3 Labelling

5.4 Organism resuscitation

6. Reference materials and reference cultures

6.1 International standards and pharmacopoeial reference substances

6.2 Reference cultures

7. Sampling

8. Sample handling and identification

9. Disposal of contaminated waste

10. Quality assurance of results and quality control of performance

10.1 Internal quality control

11. Testing procedures

12. Test reports


Further reading

Appendix 1: Examples of zones in which operations could be carried out

Appendix 2: Examples of maintenance of equipment

Appendix 3: Examples of calibration checks and intervals for different laboratory equipment

Appendix 4: Examples of equipment qualification and monitoring

Appendix 5: General use of reference cultures

WHO Good Practices Guidelines For Pharmaceutical Microbiology Laboratories

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