IWA 37-3:2022
(Main)Safety, security and sustainability of cannabis facilities and operations — Part 3: Good production practices (GPP)
Safety, security and sustainability of cannabis facilities and operations — Part 3: Good production practices (GPP)
This document specifies requirements and recommendations for organizations directly or indirectly involved in the cannabis supply chain, to enable them to: — plan, implement, operate, maintain and update a good production practice programme for providing products that are safe, according to their intended use; — demonstrate compliance with applicable statutory and regulatory requirements; — evaluate and assess mutually agreed customer requirements and demonstrate conformity to them; — effectively communicate with interested parties and demonstrate conformity to relevant interested parties; — demonstrate conformity to stated policies in a cannabis quality programme (CQP) for product safety, product quality, product security and facility safety; — support the evaluation of quality programmes by external organizations or to permit self-assessment or self-declaration of adherence to some or all of the guidance contained in this document. All requirements in this document are generic and intended to be applicable to all organizations in the cannabis supply chain, regardless of size and/or complexity. Organizations that are directly or indirectly involved include (but are not limited to) growers/cultivators, harvesters, primary processors, producers of cannabis, manufacturers of cannabis derivatives, cannabis edibles and/or cannabis products, testing providers, retailers and organizations providing transportation, storage and distribution services, suppliers of equipment, packaging materials and other contact materials. This document intended to enable any organization, including small and/or less developed organizations, to implement externally developed elements in its CQP. NOTE 1 Organizations in the cannabis supply chain are diverse in nature and not all the requirements specified in this document apply to each establishment or process. Justifications for exclusions or the use of alternative measures can be documented by a risk assessment/hazard analysis or other appropriate means. This document provides guidance related to the following categories of cannabis, cannabis derivatives and cannabis products: — cannabis plant seeds; — cannabis plants; — fresh cannabis; — dried cannabis; — cannabis derivatives; — cannabis topicals; — inhalable cannabis. NOTE 2 Annex B provides additional guidance on applying GPP to cannabis edibles with respect to requirements and recommendations in existing food safety standards. Where buildings or premises combine cultivation and processing of cannabis plants, including ancillary activities, along with other operational activities, the requirements and recommendations in this document apply only to that portion of the facility. NOTE 3 Where joint use activities are present in a common building, specific statutory and regulatory requirements can apply for each category. This document does not address the following: — requirements related to research and development activities for finished products; — general fire prevention or building construction features that are normally a function of local building and fire codes where applicable; — premises used exclusively for operational activities, such as office space, call centres and retail outlets, used for the distribution, marketing, or sale of cannabis; NOTE 4 Shipping and receiving of products from the production facility for further distribution are not considered as a retail outlet. — the safe consumption or use of the cannabis or cannabis products produced by organizations applying these good production practices; — occupational health and safety requirements governing cannabis workers and personnel except as identified in A.8.4 and A.8.6; — the protection of the environment; — security of the supply chain monitoring system, including cybersecurity and notifications; NOTE 5 Security and monitoring of the supply chain are dealt with specifically in IWA 37-2. — outdoor cultivation of cannabis and industrial hemp; — gr
Titre manque — Partie 3: Titre manque
General Information
Relations
Standards Content (Sample)
INTERNATIONAL IWA
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
© ISO 2022
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Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 2
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 . 13
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
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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
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Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO tec
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