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Homepage>ASTM Standards>ASTM D8556-24 - Standard Practice for Requirements of a Quality Management System for Cannabis and Hemp Operations
Released: 01.07.2024

ASTM D8556-24 - Standard Practice for Requirements of a Quality Management System for Cannabis and Hemp Operations

Standard Practice for Requirements of a Quality Management System for Cannabis and Hemp Operations

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Standard number:D8556-24
Released:01.07.2024
Status:Active
Pages:13
Section:15.10
Keywords:cannabis; CAPA; change management; consumer safety; continuous improvement; CQI; deviations; document control; GACP; GLP; GMP; hemp; internal audit; process control; QMS; qualifications; quality; quality management system; recall; SOPs; training;
DESCRIPTION

1.1 This practice covers a concise set of requirements for the elements of an effective quality management system (QMS) for the cannabis industry's agriculture, processing, and testing operations. Related ASTM guides and practices are available or are being written for each of the QMS elements. The available guides and practices are referenced throughout this practice. Guide D8222 provides guidance for establishing a quality management system.

1.2 Understanding the significance and use of these requirements in Section 4 is important to properly meet the requirements.

1.3 This practice applies to all types of operations from cultivation, processing, testing, distribution, and other related operations. If some QMS elements do not apply to a specific type of operation it shall be documented in the operations quality manual as described in 6.2.

1.4 Laws and regulations from authorities having jurisdiction supersede requirements within this practice.

1.5 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.

1.6 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.