-min.jpg "WHO TRS (Technical Report Series) 961, 2011 Annex 2")
WHO good practices for pharmaceutical microbiology laboratories
Background:
The WHO Expert Committee on Specifications for Pharmaceutical Preparations adopted in 2009 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 initiate the process of developing a new text on good practices for pharmaceutical microbiology laboratories.
Introduction and scope of document:
Pharmaceutical microbiology laboratories may be involved in:
— 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.
These guidelines relate to all microbiology laboratories involved in the above-mentioned testing activities, whether they are independent or a department or unit of a pharmaceutical manufacturing facility. These guidelines are based on and supplement the requirements described in Good practices for pharmaceutical quality control laboratories (1); General guidelines for the establishment, maintenance and distribution of chemical reference substances. Revision (2); The International Pharmacopoeia, Fourth Edition (3); First Supplement to The International Pharmacopoeia, Fourth Edition (4); and ISO/IEC 17025 (5).
The following text is proposed to cover this specific type of laboratory.
Click on the following title for full details: pdf
Table of Contents
6. Reference materials and reference cultures
8. Sample handling and
identification
9. Disposal of contaminated
waste
10. Quality assurance of results and quality control of
performance
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
WHO TRS (Technical Report Series) 961, 2011 Annex 2:
