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GUIDANCE ON GOOD MANUFACTURING PRACTICES

Working document August 2015 Draft document for comment 1 2 GUIDANCE ON GOOD MANUFACTURING PRACTICES : 3 inspection report 4 (AUGUST 2015) 5 DRAFT FOR COMMENT 6 7 8 9 10 11 12 13 World Health Organization 2015 14 All rights reserved. 15 This draft is intended for a restricted audience only, the individuals and organizations having received this draft. The draft 16 may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in 17 any form or by any means outside these individuals and organizations (including the organizations' concerned staff and 18 member organizations) without the permission of the World Health Organization. The draft should not be displayed on any 19 website. 20 Please send any request for permission to: 21 Dr Sabine Kopp, Group Lead, Medicines Quality Assurance, Technologies, Standards and Norms, Department of Essential 22 Medicines and Health Products, World Health Organization, CH-1211 Geneva 27, Switzerland.

Working document QAS/15.625 page 3 43 BACKGROUND 44 During an informal consultation held in 2014 discussion took place regarding the possible 45 revision of the Guidance on good manufacturing practices: Inspection report (World Health 46 Organization (WHO) (Technical Report Series, No. 908, Annex 6, 2003) to bring it in line

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Transcription of GUIDANCE ON GOOD MANUFACTURING PRACTICES

1 Working document August 2015 Draft document for comment 1 2 GUIDANCE ON GOOD MANUFACTURING PRACTICES : 3 inspection report 4 (AUGUST 2015) 5 DRAFT FOR COMMENT 6 7 8 9 10 11 12 13 World Health Organization 2015 14 All rights reserved. 15 This draft is intended for a restricted audience only, the individuals and organizations having received this draft. The draft 16 may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in 17 any form or by any means outside these individuals and organizations (including the organizations' concerned staff and 18 member organizations) without the permission of the World Health Organization. The draft should not be displayed on any 19 website. 20 Please send any request for permission to: 21 Dr Sabine Kopp, Group Lead, Medicines Quality Assurance, Technologies, Standards and Norms, Department of Essential 22 Medicines and Health Products, World Health Organization, CH-1211 Geneva 27, Switzerland.

2 Fax: (41-22) 791 4730; 23 email: 24 The designations employed and the presentation of the material in this draft do not imply the expression of any opinion 25 whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or 26 of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate 27 border lines for which there may not yet be full agreement. 28 The mention of specific companies or of certain manufacturers products does not imply that they are endorsed or 29 recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors 30 and omissions excepted, the names of proprietary products are distinguished by initial capital letters.

3 31 All reasonable precautions have been taken by the World Health Organization to verify the information contained in this 32 draft. However, the printed material is being distributed without warranty of any kind, either expressed or implied. The 33 responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health 34 Organization be liable for damages arising from its use. 35 This draft does not necessarily represent the decisions or the stated policy of the World Health Organization. 36 Should you have any comments on the attached text, please send these to Dr S. Kopp, Dr S. Kopp, Group Lead, Medicines Quality Assurance, Technologies, Standards and Norms with a copy to Ms Marie Gaspard by 1 October 2015. Medicines Quality Assurance working documents will be sent out electronically only and will also be placed on the Medicines website for comment under Current projects.

4 If you do not already receive our draft working documents please let us have your email address (to and we will add it to our electronic mailing list. Working document page 2 SCHEDULE FOR THE PROPOSED ADOPTION PROCESS OF DOCUMENT 37 : 38 GUIDANCE ON GOOD MANUFACTURING PRACTICES : inspection report 39 40 41 42 Draft proposal presented to and discussed at the informal consultation on inspection , GMP and risk management GUIDANCE in medicines MANUFACTURING 28 30 April 2014 Presentation of meeting recommendations to the forty-ninth meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations 13 17 October 2014 Preparation of draft proposal for revision by Mr D. Mubangizi, Head of the WHO Prequalification Team-Inspections, based on the current trends; formats used for convergence purposes of the format October 2014 April 2015 Document sent out for comments August 2015 Compilation of comments received Beginning of October 2015 Submission to fiftieth meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations 12 16 October 2015 Any further action, as recommended by the WHO Expert Committee on Specifications for Pharmaceutical Preparations.)

5 Working document page 3 BACKGROUND 43 During an informal consultation held in 2014 discussion took place regarding the possible 44 revision of the GUIDANCE on good MANUFACTURING PRACTICES : inspection report (World Health 45 Organization (WHO) (Technical report Series, No. 908, Annex 6, 2003) to bring it in line 46 with the current format used with the inspection Group of the Prequalification Team (PQT) 47 and the formats currently used internationally in national and regional inspectorates. 48 The need for revision was brought to the attention of the WHO Expert Committee on 49 Specifications for Pharmaceutical Preparations by the PQT inspectors. It agreed that, in light 50 of the new developments, a draft for revision be prepared.)

6 51 This proposed update was drafted over the past months reviewing the various formats and 52 considering efforts of inspectorates and regulatory agencies, as well as the Pharmaceutical 53 inspection Co-operation Scheme (PIC/S) towards convergence. 54 55 56 57 Working document page 4 Contents 58 page 59 1. Introduction .. 4 60 2. Scope .. 4 61 3. Glossary ..4 62 4. General principles .. 5 63 Appendix 1: Model inspection report .. 9 64 65 66 GUIDANCE ON GOOD MANUFACTURING PRACTICES : inspection report 67 1. INTRODUCTION 68 This GUIDANCE describes general principles and a recommended format for inspection reports 69 for use by organizations performing pharmaceutical inspections. It aims to support 70 convergence of PRACTICES in drawing up inspection reports so as to facilitate cooperation and 71 information-sharing.

7 72 2. SCOPE 73 This guideline applies to reports on inspections of active pharmaceutical ingredients (APIs) 74 and finished pharmaceutical products (FPPs). A separate template is provided for inspections 75 of contract research organizations (CROs) and quality control laboratories. 76 3. GLOSSARY 77 correction. A correction is any action that is taken to eliminate a nonconformity. 78 However, corrections do not address causes. When applied to products, corrections can 79 include reworking products, reprocessing them, regarding them, assigning them to a different 80 use, or simply destroying them. 81 corrective action. Corrective actions are steps that are taken to eliminate the causes 82 of existing nonconformities in order to prevent recurrence.

8 The corrective action process tries 83 to make sure that existing nonconformities and potentially undesirable situations do not 84 happen again. While corrective actions prevent recurrence, preventive actions prevent 85 occurrence. Both types of actions are intended to prevent nonconformities. 86 corrective and preventive action. A system for implementing correction actions and 87 preventive actions resulting from an investigation of complaints, product rejections, non-88 conformances, recalls, deviations, audits, regulatory inspections and findings, and trends 89 from process performance and product quality monitoring. 90 91 deficiency. Non-fulfilment of a requirement. This sense it can be used 92 interchangeably with nonconformity . 93 inspection observation.

9 An inspection observation is a finding or a statement of fact 94 made during an inspection and substantiated by objective evidence. Such findings may be 95 positive or negative. Positive observations should take the form of a description of the 96 Working document page 5 processes that the firm is carrying out particularly well and that may be considered examples 97 of particularly good regulated practice. Negative observations are non-compliance with 98 requirements. 99 nonconformity. Nonconformity refers to a failure to comply with requirements. A 100 requirement is a need, expectation or obligation. It can be stated or implied by an 101 organization, its customers or other interested parties. There are many types of requirements.

10 102 Some of these include quality requirements, customer requirements, management 103 requirements, product requirements, and legal requirements. Whenever an organization fails 104 to meet one of these requirements, a nonconformity occurs. 105 observations. The term observations is often limited to areas pointed out by the 106 inspector as being in compliance but very close to becoming a nonconformance or that given 107 additional evidence could transform into a nonconformance. In this sense, observations can 108 be looked as accidents waiting to happen . 109 preventive action. Preventive actions are steps that are taken to remove the causes of 110 potential nonconformities or potential situations that are undesirable. 111 112 4. GENERAL PRINCIPLES 113 When a site at which pharmaceutical products are manufactured is inspected, the 114 inspector(s) responsible should draw up a report .


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