ASTM WK60084

    New Practice for Quality Management System (QMS) on Corrective Action Preventive Action (CAPA) for Cannabis Cultivation, Processing, Manufacturing, Testing, and Distribution

    (What is a Work Item?)

    Developed by Subcommittee: D37.02 | Committee D37 | Contact Staff Manager



    WK60084

    1. Scope

    1.1 This practice applies to all entities that cultivate, process/manufacture, test, and distribute cannabis products. 1.2 This practice shall define the role of the corrective action preventive action (CAPA) system and the significance of an effective CAPA system within the quality management system (QMS). 1.3 This practice shall provide guidance on the establishment of adequate processes and procedures for the detection, measurement, analysis, and improvement of quality issues in the QMS related to CAPA. 1.4 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 and health practices and determine the applicability of regulatory limitations prior to use.


    Keywords

    cannabis; CAPA; corrective action preventive action; hemp

    Rationale

    A Quality Management System (QMS) is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organizations activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis. The Corrective Action Preventive Action (CAPA) subsystem is a critical component of an effective QMS. Most regulatory actions taken by the FDA and other regulatory bodies are linked to inadequate CAPA systems. The purpose of the CAPA subsystem is to collect information/data to detect product and quality problems, investigate root cause of product and quality problems, identify and implement appropriate corrective and/or preventive actions to prevent recurrence or occurrence, and monitor effectiveness of implemented corrective and/or preventive actions through a change management system. The change management system is used in verifying and validating corrective and preventive actions before implementation, properly disseminating information regarding corrective and preventive actions and documenting all CAPA related activities are essential to ensuring the CAPA subsystem is compliant, effective, and efficient. A CAPA subsystem shall be a closed loop system that quantifies system inputs and outputs. CAPA applies a systematic approach to problem resolution and shall maintain a close relationship with other quality systems subsystems. All CAPA related activities shall use a risk-based approach to prioritize existing or potential issues or both based on the criticality and magnitude of the situation.

    The title and scope are in draft form and are under development within this ASTM Committee.

    Citing ASTM Standards
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    Work Item Status

    Date Initiated:
    08-07-2017

    Technical Contact:
    Kathleen May

    Item:
    002

    Ballot:
    D37 (19-02)

    Status:
    Ballot Item Approved

    Item:
    003

    Ballot:
    D37 (19-02)

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    Ballot Item Approved

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    004

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    D37 (19-02)

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    Ballot Item Approved

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    005

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    D37 (19-02)

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    Ballot Item Approved

    Item:
    006

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    D37 (19-02)

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    Ballot Item Approved

    Item:
    007

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    D37 (19-02)

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    Ballot Item Approved

    Item:
    008

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    D37 (19-02)

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    Ballot Item Approved

    Item:
    009

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    D37 (19-02)

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    Ballot Item Approved

    Item:
    010

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    D37 (19-02)

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    Ballot Item Approved

    Item:
    011

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    D37 (19-02)

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    Ballot Item Approved

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    012

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    D37 (19-02)

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    Ballot Item Approved

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    013

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    D37 (19-02)

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    Ballot Item Approved

    Item:
    014

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    D37 (19-02)

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    Ballot Item Approved

    Item:
    013

    Ballot:
    COS (19-05)

    Status:
    Ballot Item Approved as D8229-2019 and Pending Publication