IWA INTERNATIONAL WORKSHOP 37-3 AGREEMENT First edition 2022-10 Safety, security and sustainability of cannabis facilities and operations - Part 3: Good production practices (GPP) Reference number IWA 37-3:2022(E) ISO @IS02022 IWA 37-3:2022(E) COPYRIGHT PROTECTED DOCUMENT @ IS02022 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet oran intranet, without prior written permission.Permission can berequested from either Iso attheaddress below orIso's memberbody inthe countryoftherequester. ISO copyright office CP 401 · Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +4122 749 0111 Email: [email protected] Website: www.iso.org Published in Switzerland i @ IS0 2022 - All rights reserved IWA 37-3:2022(E) Contents Page Foreword. ..V Introduction. ..vi 1 Scope. ..1 2 Normative references 3 Terms and definitions. .2 4 General .10 4.1 Understanding the organization and its context. .10 4.2 Understanding the needs and expectations of interested parties. ..10 4.3 Establishing the CQP .11 4.3.1 General .11 4.3.2 Control of externally provided processes, products or services .11 4.4 Licences. 11 4.5 Policy .11 4.5.1 Establishing the CQP policy .11 4.5.2 Communicating the CQP policy .12 4.6 Organizational roles, responsibilities and authorities .12 4.6.1 General .12 4.6.2 Quality and safety team leader .12 4.6.3 Product security 4.7 Planning of changes .13 5 Support. ..13 5.1 Resources. ..13 5.1.1 General 13 5.1.2 People .14 5.1.3 Infrastructure .14 5.1.4 Work environment. .14 5.2 Documented information. .14 5.2.1 General .14 5.2.2 Creating and updating .15 5.2.3 Control of documented information .15 5.2.4 Data integrity and backup. .15 6 Designing and implementing GPP within the operation ..15 6.1 Development of processes. .15 6.2 Establishing criteria for processes. 16 6.2.1 Characteristics of raw materials, ingredients and product contact materials. .16 6.2.2 Characteristics of end products (finished products) 16 6.2.3 Intended use.. 17 6.2.4 Flow diagrams and description of processes 17 6.3 Risk assessment/Hazard analysis .18 6.3.1 General 18 6.3.2 Hazard identification and determination of acceptable levels .18 6.3.3 Hazard assessment 19 6.3.4 Selection and categorization of control measures 19 6.4 Implementing process controls. 20 6.4.1 Good production practices (GPP) 20 6.4.2 Control measures for significant hazards 21 6.4.3 Validation of control measures for significant hazards 21 6.4.4 Control of monitoring and measuring methods. 22 6.5 Process control documentation 22 6.5.1 Master manufacturing records (MMRs) 22 6.5.2 Batch manufacturing records... .23 6.6 Verification related to GPP and the hazard control plan 24 @ IS0 2022 - All rights reserved iii IWA 37-3:2022(E) 6.6.1 Verification 24 6.6.2 Verification results 24 6.6.3 Analysis of results of verification activities 25 6.7 Laboratory system/Product testing .25 6.7.1 Testing for phytocannabinoids 25 6.7.2 Testing for contaminants. 25 6.7.3 Testing for pesticides. 26 6.7.4 Sample retention 26 6.7.5 Durable life/Durable life date 26 6.8 Control of product and process nonconformities 27 6.8.1 General 27 6.8.2 Corrections 27 6.8.3 Corrective actions 28 6.8.4 Handling of potentially unsafe products 28 6.9 Complaint management 30 6.10 Identification and traceability 30 6.11 Packaging system 31 6.11.1 General 31 6.11.2 Packaging: Sustainability, safety and quality 31 6.11.3 Packaging: Containers and wrappers. 31 6.11.4 Packaging labelling: Product identifiers 32 6.11.5 Packaging labelling: Advertising. 33 Annex A (normative) GPP for cannabis and cannabis product quality and safety .34 Annex B (informative) Guidance on applying GPP to cannabis edibles .54 Bibliography .66 iv IS02022-All rightsreserved IWA 37-3:2022(E) Foreword IsO (the International Organization f