Good manufacturing practices guide for drug products

1 Good manufacturing practices guide for drug products GUI-0001 February 28, 2018 Good manufacturing practices guide for drug products (GUI-0001) Author: Health Canada Date issued: February 28, 2018 Implementation Date: October 1, 2018 Replaces: Good manufacturing practices (GMP) Guidelines 2009 Edition, version 2 (March 4, 2011) Disclaimer This document does not constitute part of the Food and Drugs Act (the Act) or its regulations and in the event of any inconsistency or conflict between the Act or regulations and this document, the Act or the regulations take precedence.

2 This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the regulations and the applicable administrative policies. Ce document est aussi disponible en fran ais. Good manufacturing practices guide for drug products (GUI-0001) Page 3 of 156 Table of contents About this 6 1. Purpose .. 6 2. Scope .. 6 3. Introduction .. 7 Checklist GMP regulations by activity .. 8 About quality management .. 10 4. Pharmaceutical quality system .. 10 Guiding principles .. 10 Developing a pharmaceutical quality system.

3 10 Good manufacturing practices for drugs .. 13 Quality control .. 14 Quality risk management .. 16 Guidance .. 16 5. Regulations .. 16 .. 16 .. 17 Sale .. 17 .. 17 .. 17 .. 18 Use in fabrication .. 18 .. 18 Premises .. 18 .. 18 Equipment .. 22 .. 22 25 .. 25 Sanitation .. 28 .. 28 .. 30 Raw material testing .. 32 Good manufacturing practices guide for drug products (GUI-0001) Page 4 of 156 .. 32 .. 37 manufacturing control .. 41 .. 41 .. 52 Quality control department .. 58 .. 59 .. 61.

4 64 Packaging material testing .. 71 .. 71 .. 73 Finished product testing .. 76 .. 76 .. 78 Records .. 84 .. 84 .. 85 .. 86 .. 87 .. 87 .. 88 Samples .. 95 .. 95 .. 96 Stability .. 98 .. 98 Checklists 101 .. 104 Sterile products .. 106 .. 106 Medical gases .. 107 .. 107 Appendices .. 108 Appendix A Glossary .. 108 Acronyms .. 108 Terms .. 109 Appendix B Questions and answers .. 122 Good manufacturing practices guide for drug products (GUI-0001) Page 5 of 156 Premises .. 122 Equipment.

5 124 Personnel .. 124 Sanitation , .. 125 Raw material testing , .. 127 manufacturing control , .. 131 Quality control department , , .. 136 Packaging material testing , .. 139 Finished product testing , .. 139 Records , , , , , .. 144 Samples , .. 145 Stability , .. 147 Sterile products .. 148 Appendix C 149 Laws and regulations .. 149 Annexes to GUI-0001 .. 149 Good manufacturing practices .. 151 Validation guidelines .. 151 Recall procedures .. 152 Other related documents.

6 152 International guidance documents .. 153 Good manufacturing practices guide for drug products (GUI-0001) Page 6 of 156 About this document 1. Purpose This guide is for people who work with drugs as: fabricators packagers labellers testers distributors importers wholesalers It will help you understand and comply with Part C, Division 2 of the Food and Drug Regulations (the Regulations), which is about good manufacturing practices (GMP). You can find definitions to terms used in this guide under Appendix A.

7 2. Scope These guidelines apply to these types of drugs: pharmaceutical radiopharmaceutical biological veterinary Good manufacturing practices guide for drug products (GUI-0001) Page 7 of 156 The scope of this document does not include: Establishment licensing To understand how to comply with GMP requirements to get an establishment licence, see Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees (GUI-0002). Active pharmaceutical ingredients Guidelines for active pharmaceutical ingredients (APIs) are described in Health Canada s Good manufacturing practices for active pharmaceutical ingredients (GUI-0104).

8 3. Introduction These guidelines interpret the requirements for good manufacturing practices (GMP) in Part C, Division 2 of the Regulations. They were developed by Health Canada in consultation with stakeholders. Guidance documents like this one are meant to help industry and health care professionals understand how to comply with regulations. They also provide guidance to Health Canada staff, so that the rules are enforced in a fair, consistent and effective way across Canada. Health Canada inspects establishments to assess their compliance with the Food and Drugs Act (the Act) and associated regulations.

9 When we conduct an inspection, we will use this document as a guide in assessing your compliance with GMP requirements. To better understand how risk ratings are assigned during inspections, see Risk Classification of Good manufacturing practices (GMP) Observations (GUI-0023). These guidelines are not the only way GMP regulations can be interpreted, and are not intended to cover every possible case. Other ways of complying with GMP regulations will be considered with proper scientific justification. Also, as new technologies emerge, different approaches may be called for.

10 Guidance documents are administrative and do not have the force of law. Because of this, they allow for flexibility in approach. So use this guide to help you develop specific approaches that meet your unique needs. The guidance in this document has been written with a view to harmonize with GMP standards from: Good manufacturing practices guide for drug products (GUI-0001) Page 8 of 156 the World Health Organization (WHO) the Pharmaceutical Inspection Cooperation/Scheme (PIC/S) the International Council on Harmonisation (ICH) the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal products (VICH) other regulatory agencies in other countries This document also takes into account current mutual recognition agreements (MRA)