ASTM D8398-22

ASTM D8398-22 is a standard published by ASTM International. Its full title is "Standard Practice for Management Responsibilities in Managing a Quality Management System (QMS)". This standard covers: SIGNIFICANCE AND USE 4.1 This practice is for any cannabis operation to use as a fundamental part of a robust quality management system (QMS). 4.2 Regulators can use this practice to develop regulations that require the implementation of QMS principles, specifically management’s role and responsibilities. Further, regulators can use this practice to help build a checklist to evaluate management’s engagement and compliance with QMS based regulations. 4.3 Auditors would use this practice to assess the level of management engagement with an operations QMS. 4.4 Any cannabis operation that has implemented or seeks to implement a QMS would use this practice. SCOPE 1.1 This practice provides the management responsibilities for the implementation and oversight of a quality management system (QMS). It can be applied to all cannabis operations, including cultivation, manufacturing, labeling, dispensing, and distribution. This practice does not address the quality management system details, but rather focuses on the main considerations for management’s role in setting up a QMS. Guide D8222 provides an overview and some details about the components of a QMS. Other standards provide details on specific QMS components. 1.2 The term GxP as used in this practice is meant to include those good practices in the activities included in 1.1; namely cultivation, manufacturing, distribution, and all the relevant functions associated with these activities (for example, purchasing, testing, storing, and so forth). 1.3 Although this practice mentions the importance of health and safety, it is done so in the context of overall management responsibility. This practice does not address details of a health and safety system, but it identifies the importance of this as a management responsibility. 1.4 This practice encompasses a single component of the QMS (management responsibilities) that, when combined with the other elements, satisfies the requirements of a complete QMS. 1.5 The practices described in this standard are intended to apply to all products of a cannabis plant including those that can be classified as hemp and which contain cannabinoids and can be consumed/ingested via mouth, nose, skin (whether described as medicine, supplements, food, cosmetics, and so forth.). 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE 4.1 This practice is for any cannabis operation to use as a fundamental part of a robust quality management system (QMS). 4.2 Regulators can use this practice to develop regulations that require the implementation of QMS principles, specifically management’s role and responsibilities. Further, regulators can use this practice to help build a checklist to evaluate management’s engagement and compliance with QMS based regulations. 4.3 Auditors would use this practice to assess the level of management engagement with an operations QMS. 4.4 Any cannabis operation that has implemented or seeks to implement a QMS would use this practice. SCOPE 1.1 This practice provides the management responsibilities for the implementation and oversight of a quality management system (QMS). It can be applied to all cannabis operations, including cultivation, manufacturing, labeling, dispensing, and distribution. This practice does not address the quality management system details, but rather focuses on the main considerations for management’s role in setting up a QMS. Guide D8222 provides an overview and some details about the components of a QMS. Other standards provide details on specific QMS components. 1.2 The term GxP as used in this practice is meant to include those good practices in the activities included in 1.1; namely cultivation, manufacturing, distribution, and all the relevant functions associated with these activities (for example, purchasing, testing, storing, and so forth). 1.3 Although this practice mentions the importance of health and safety, it is done so in the context of overall management responsibility. This practice does not address details of a health and safety system, but it identifies the importance of this as a management responsibility. 1.4 This practice encompasses a single component of the QMS (management responsibilities) that, when combined with the other elements, satisfies the requirements of a complete QMS. 1.5 The practices described in this standard are intended to apply to all products of a cannabis plant including those that can be classified as hemp and which contain cannabinoids and can be consumed/ingested via mouth, nose, skin (whether described as medicine, supplements, food, cosmetics, and so forth.). 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ASTM D8398-22 is classified under the following ICS (International Classification for Standards) categories: 03.120.10 - Quality management and quality assurance; 11.120.99 - Other standards related to pharmaceutics. The ICS classification helps identify the subject area and facilitates finding related standards.

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