GUIDELINES ON VALIDATION APPENDIX 4 ANALYTICAL …

1 Working document September 2018. Draft document for comments 1. 2 GUIDELINES ON VALIDATION APPENDIX 4. 3 ANALYTICAL METHOD VALIDATION . 4. 5 (September 2018). 6. 7 DRAFT FOR COMMENTS. 8. 9. Please forward any comments you may have on the attached text to Dr Sabine Kopp, Group Lead, 10. 11. Medicines Quality Assurance, Technologies, Standards and Norms with a copy to Mrs Xenia Finnerty by 15 November 2018. 12. 13. Medicines Quality Assurance working documents will only be sent out electronically and will 14. 15. also be placed on the Medicines website for comments under Current projects . If you have 16. not already received our draft working documents, please send your email address (to 17.)

2 18. and we will add it to our electronic mailing list. 19. 20. 21. 22. 23 World. Health Organization 2018. 24. 25 All rights reserved. 26. 27 This draft is intended for a restricted audience only, the individuals and organizations having received this draft. The draft 28 may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any 29 form or by any means outside these individuals and organizations (including the organizations' concerned staff and member 30 organizations) without the permission of the World Health Organization. The draft should not be displayed on any website.

3 31. 32 Please send any request for permission to: 33. 34 Dr Sabine Kopp, Group Lead, Medicines Quality Assurance, Technologies, Standards and Norms, Regulation of Medicines and 35 other Health Technologies, Department of Essential Medicines and Health Products, World Health Organization, CH-1211. 36 Geneva 27, Switzerland, fax: (41-22) 791 4856; email: 37. 38 The designations employed and the presentation of the material in this draft do not imply the expression of any opinion 39 whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its 40 authorities, or concerning the delimitation of its frontiers or boundaries.

4 Dotted lines on maps represent approximate border lines 41 for which there may not yet be full agreement. 42. 43 The mention of specific companies or of certain manufacturers' products does not imply that they are endorsed or recommended 44 by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions 45 excepted, the names of proprietary products are distinguished by initial capital letters. 46. 47 All reasonable precautions have been taken by the World Health Organization to verify the information contained in this draft. 48 However, the printed material is being distributed without warranty of any kind, either expressed or implied.

5 The responsibility 49 for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for 50 damages arising from its use. 51. 52 This draft does not necessarily represent the decisions or the stated policy of the World Health Organization. Working document page 2. 53 SCHEDULE FOR THE PROPOSED ADOPTION PROCESS OF DOCUMENT : 54 GUIDELINES ON VALIDATION APPENDIX 4. 55 ANALYTICAL METHOD VALIDATION . 56. Discussion of proposed need for revision in view of the current trends in VALIDATION during informal consultation on 29 June . data management, bioequivalence, good manufacturing 1 July 2015.

6 Practices (GMP) and medicines' inspection. Preparation of draft proposal for revision of the main text and several appendices by specialists in collaboration with the Medicines Quality Assurance Group and Prequalification July 2015 . Team (PQT)-Inspections, based on the feedback received April 2016. during the meeting and from PQT-Inspections, draft proposals developed on the various topics by specialists, as identified in the individual working documents. Presentation of the progress made to the fiftieth meeting of the WHO Expert Committee on Specifications for 12 16 October 2015. Pharmaceutical Preparations (ECSPP). Discussion at the informal consultation on good practices for 4 6 April 2016.

7 Health products manufacture and inspection, Geneva. Preparation of revised text by Ms S. Croft, member of the PQT-Inspections Team, and review by Dr van Zyl, participant at the above-mentioned consultation, based on the May 2016. feedback received during the informal consultation by the meeting participants and members of PQT-Inspections. Circulation of revised working document for public June 2016. consultation. Consolidation of comments received and review of feedback. August September 2016. Presentation to the fifty-first meeting of the ECSPP. 17 21 October 2016. Review of feedback and changes proposed by an ANALYTICAL May-June 2018.

8 Chemist, Dr C. Langfermann, Germany. Discussion at the informal consultation on GMP and 10-12 July 2018. inspection tools, Geneva. Cleaning up of changes suggested during consultation and circulation of revised working document for public August - September 2018. consultation. Consolidation of comments received and review of feedback. October- November 2018. Presentation to the fifty-third meeting of the ECSPP. 22 26 October 2018. Any other follow-up action as required.. Working document page 3. 57 BACKGROUND INFORMATION. 58. 59 The need for revision of the published Supplementary GUIDELINES on good manufacturing 60 practices: VALIDATION (1) was identified by the Prequalification of Medicines Programme and a 61 draft document was circulated for comments in early 2013.

9 The focus of the revision was the 62 APPENDIX on non-sterile process VALIDATION ( APPENDIX 7) which had been revised and was 63 adopted by the Expert Committee at its forty-ninth meeting in October 2014. 64. 65 The main text was sent out for consultation as a Working document entitled 66 GUIDELINES on VALIDATION which constituted the general principles of the new guidance on 67 VALIDATION . 68. 69 The draft on the specific topics, the appendices to this main text, will follow. One of them, 70 ANALYTICAL method VALIDATION , constitutes this working document. 71. 72 The following is an overview on the appendices that are intended to complement the general text 73 on VALIDATION : 74.

10 75 APPENDIX 1. 76 VALIDATION of heating, ventilation and air-conditioning systems (HVAC). 77 will be replaced by cross-reference to the World Health Organization (WHO). 78 GUIDELINES on GMP for HVAC systems for considerations in qualification of HVAC. 79 systems (Annex 8 in TRS 1010, 2018). 80. 81 APPENDIX 2. 82 VALIDATION of water systems for pharmaceutical use 83 will be replaced by cross-reference to the WHO GUIDELINES on water for 84 pharmaceutical use for consideration in qualification of water purification systems. 85. 86 APPENDIX 3. 87 Cleaning VALIDATION consensus to retain. 88. 89 APPENDIX 4. 90 ANALYTICAL method VALIDATION updated text proposed in this working document.