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Working document QAS/13.521
February 2013
RESTRICTED
GENERAL GUIDANCE FOR INSPECTORS
ON “HOLD-TIME” STUDIES
DRAFT FOR COMMENT
Should you have any comments on the attached text, please send these to
Dr Sabine Kopp, Manager, Medicines Quality Assurance Programme, Quality Assurance
and Safety: Medicines, World Health Organization, 1211 Geneva 27, Switzerland;
e-mail: kopps@; fax: (+41 22) 791 4730 (kopps@) and to
Ms Marie Gaspard (gaspardm@), by 12 April 2013.
Working documents are sent out electronically and they will also be placed on the
Medicines web site for comment. If you do not already receive directly our draft
guidelines please let us have your e-mail address (to bonnyw@) and we will
add it to our electronic mailing list.
___________________________________________________________________________
© World Health Organization 2013
All rights reserved.
This draft is intended for a 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 web site.
Please send any request for permission to:
Dr Matthias Stahl, Prequalification of Medicines Programme, Medicines Quality Assurance Programme, Quality
Assurance and Safety: Medicines, Department of Essential Medicines and Pharmaceutical Policies, World Health
Organization, CH-1211 Geneva 27, Switzerland; e-mail: stahlm@.
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 border lines 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.
Working document QAS/13.521
page 2
SCHEDULE FOR THE ADOPTION PROCESS OF DOCUMENT QAS/13.521
GENERAL GUIDANCE FOR INSPECTORS ON “HOLD-TIME” STUDIES
Preparation of draft by Dr A.J. van Zyl,
South Africa, based on need identified by
the WHO Prequalification Programme
inspectors
Preliminary internal review of draft
Draft mailed for comments
Collation of comments
Review by inspectors collaborating with the
WHO Prequalification Programme
Recirculation for comments
Collation of comments
Presentation to forty-eighth meeting of the
WHO Expert Committee on Specifications
for Pharmaceutical Preparations
Further follow-up action as required
Date
November-December 2012
January 2013
February 2013
April 2013
May 2013
June 2013
September 2013
14-18 October 2013
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