WHO Technical Report including Annex 2 "Good Practices for pharmaceutical microbiological Laboratories"
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Beginning of June 2011, after submitting to the WHO Executive Board, the WHO Expert Committee published their Technical Report on specifications for pharmaceutical preparations. In its Annex 2 this report includes the "WHO good practices for pharmaceutical microbiology laboratories".
In 2009 the WHO Expert Committee on Specifications for Pharmaceutical Preparations adopted a revised version of the Good practices for pharmaceutical quality control laboratories (1). During the inspections carried out when prequalifying laboratories, the inspectors had noticed that some of the texts of these guidelines might benefit from additional guidance, with a special focus on microbiology. In light of the above, the Expert Committee recommended that the WHO Secretariat initiates the process of developing a new text on good practices for pharmaceutical microbiology laboratories.
Table of Content:
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
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
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
The guideline is related to all microbiological laboratories who are related to
detection, isolation, enumeration and identification of microorganisms (bacteria, yeast and moulds) and testing for bacterial endotoxins in different materials (e.g. starting materials, water), products, surfaces, garments and the environment; and
assay using microorganisms as part of the test system.