Microsoft Word Pharmaceutical-Microbiology-Labs qas09-297Rev2 28072010. doc



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Working document QAS/09.297/Rev.2 July 2010 RESTRICTED

WHO GOOD PRACTICES FOR
PHARMACEUTICAL MICROBIOLOGY LABORATORIES

DRAFT FOR COMMENT

© World Health Organization 2010 All rights reserved. This draft is intended fora restricted audience only, i.e. the individuals and organizations having received this draft. The draft may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any form or by any means outside these individuals and organizations (including the organizations' concerned staff and member organizations) without the permission of the World Health Organization. The draft should not be displayed on any website. Please send any request for permission to Dr A.J. van Zyl, Head of Inspections, Prequalification Programme, Quality Assurance and Safety Medicines, Department of Essential Medicines and Pharmaceutical Policies, World Health Organization, CH Geneva 27, Switzerland email vanzyla@who.int
The designations employed and the presentation of the material in this draft do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate borderlines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this draft. However, the printed material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. This draft does not necessarily represent the decisions or the stated policy of the World Health Organization. Please address comments on this proposal, by 1 October 2010, to Dr A.J. van Zyl, Head of Inspections, Prequalification Programme, Quality Assurance and Safety Medicines, World Health Organization, 1211 Geneva 27, Switzerland, email vanzyla@who.int with a copy to Mrs M. Gaspard (gaspardm@who.int).


During the past few years we have moved more towards an electronic system
Introduction and scope of document
Zone installation
Environmental monitoring in the laboratory
Sterility test facilities
Validation of test methods
Calibration and monitoring
Reagents and culture media
Reference materials and reference cultures
Note from secretariat
Sample handling and identification
Disposal of contaminated waste
Appendix b examples of calibration and calibration checks
Appendix db bexamples of maintenance of equipment

Directory: medicines


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