WHO Technical Report including Annex 2 "Good Practices for pharmaceutical microbiological Laboratories"

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:

  • 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
  • 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

  • sterility testing;
  • 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.

The full document can be found here.

Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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