Working document QAS/13.527/Rev.1 April 2014 RESTRICTED
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PROPOSAL FOR REVISION OF THE SUPPLEMENTARY GUIDELINES ON GOOD MANUFACTURING PRACTICES: VALIDATION, APPENDIX 7:NON-STERILE PROCESS VALIDATION
(APRIL 2014) DRAFT FOR COMMENT
Should you have any comments on the attached text, please send these to: Dr Sabine Kopp, Group Lead, Medicines Quality Assurance, Technologies, Standards and Norms, World Health Organization, 1211 Geneva 27, Switzerland; email: kopps@who.int; fax: (+41 22) 791 4730 (kopps@who.int) and to Ms Marie Gaspard (gaspardm@who.int), by 29 April 2014. Working documents are sent out electronically and they will also be placed on the Medicines website for comment. If you do not already receive directly our draft guidelines please let us have your email address (to bonnyw@who.int) and we will add it to our electronic mailing list.
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© World Health Organization 2014 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 website. Please send any request for permission to: Dr Sabine Kopp, Group Lead, Medicines Quality Assurance, Technologies, Standards and Norms, Department of Essential Medicines and Health Products, World Health Organization, CH-1211 Geneva 27, Switzerland. Fax: (41-22) 791 4730; email: kopps@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 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/13.527/Rev.1 page 2
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SCHEDULE FOR THE PROPOSED ADOPTION PROCESS OF DOCUMENT QAS/13.527: PROPOSAL FOR REVISION OF THESUPPLEMENTARY GUIDELINE ON GOOD MANUFACTURING PRACTICES: VALIDATION, APPENDIX 7: NON-STERILE PROCESS VALIDATION
Need for revision of published good manufacturing practices: validation identified by Prequalification of Medicines Programme Wide circulation of draft document for comment Compilation of feedback received Discussion of feedback during informal consultation on quality assurance guidelines Mailing o
f revision for comment Presentation to forty-eighth meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
Recirculation of working document for comments Compilation of comments Discussion of feedback during informal consultation on medicines quality: GXPs, inspection guides and risk management Recirculation of updated working document Compilation of comments and evaluation of feedback received Presentation to forty-ninth meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations Further follow-up action as required 43
March 2013
April 2013 June 2013 July 2013 August 2013 October 2013
March 2014 April 2014 28-30 April 2014
May 2014 July 2014 October 2014
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Working document QAS/13.527/Rev.1 page 3
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PROPOSAL FOR REVISION OF THESUPPLEMENTARY GUIDELINE ON GOOD MANUFACTURING PRACTICES: VALIDATION, APPENDIX 7: NON-STERILE PROCESS VALIDATION
Note from the Secretariat: The current text of the Supplementary guideline on good manufacturing practices: validation ( World Health Organization, WHO Technical Report Series, No. 937, 2006, Annex 4) is available on the following website:
www.who.int/medicines/areas/quality_safety/quality_assurance/production/en/index.html
Moreover, comments are being sought at the same time as to whether the Appendix 3 on Cleaning validation be revised to be in line with the current developments on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities; if yes, concrete proposals for revision would be appreciated. The Appendixes of the Supplementary guideline on good manufacturing practices:
validation are currently as follows:
Appendix 1. Validation of heating, ventilation and air-conditioning systems – TO BE REVISED Appendix 2. Validation of water systems for pharmaceutical use – TO BE REVISED
Appendix 3. Cleaning validation
– TO BE REVISED
Appendix 4. Analytical method validation
Appendix 5. Validation of computerized systems – TO BE REVISED
Appendix 6 - Qualification of systems and equipment – TO BE REVISED
Appendix 7. Non-sterile process validation – proposed to be revised
Working document QAS/13.527/Rev.1 page 4
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validation verification
Proposal for revision of the Supplementary Guideline on Good Manufacturing Practices: Validation Appendix 7: Non-sterile process validation
Contents page 1. Background and scope 2. Glossary 3. Introduction 4. Process design 5. Process Qualification 6. Continued Process Verification 7. Change control References
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BACKGROUND AND SCOPE
Further to the Supplementary guideline on good manufacturing practices: validation, as published in the World Health Organization (WHO) Technical Report Series, No. 937,1 additional guidelines to support current approaches in good manufacturing practices (GMP) are published herewith to further support the scope of process validation (also referred to as process qualification) linked to quality risk management and quality by design principles as described by WHO and the International Conference on Harmonisation (ICH).
This guideline allows for different approaches in process validation. The principles described in this guideline are mainly applicable to non-sterile finished pharmaceutical dosage forms. Similar approach
es may be applicable to active pharmaceutical ingredients (APIs) and sterile products. (See also recommendations in WHO Technical Report Series, No. 957, Annex 2 and WHO Technical Report Series, No. 961, Annex 6.)
Supplementary guidelines on good manufacturing practices: validation. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fortieth report. Geneva, World Health Organization. WHO Technical Report Series, No. 937 (Annex 5), 2006.
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Thorough knowledge of product and process development studies; previous manufacturing experience; and quality risk management (QRM) principles are essential in all approaches to process validation as the focus is now on the life-cycle approach. The life-cycle approach links product and process development, validation of the commercial manufacturing process and maintaining the process in a state of control during routine commercial production.
A risk-based approach in validation is recommended. The use of in-line, online and/or at-line controls and monitoring are recommended to ensure that a process is in a state of control during manufacture
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GLOSSARY
at line Measurement where the sample is removed, isolated from, and analysed in close proximity to the process stream.
concurrent validation Validation carried out during routine production of products intended for sale.
control strategy A planned set of controls, derived from current product and process understanding that assures process performance and product quality. The controls can include parameters and attributes related to drug substance and pharmaceutical product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control.
continued process verification (CPV) Documented scientific evidence that the process remains in a state of control during commercial manufacture.
critical process parameter (CPP) A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored and/or controlled to ensure the process produces the

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