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    01 Corrective and Preventive Action CAPA V1 3 P3

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    him_che1272
    This procedure will provide guidance on the requirements and use of the system as well as the procedure for processing CAPAs. The CORRECTIVE AND PREVENTIVE ACTION system assures the tracking and trending of issues requiring mid-term and long-term corrective actions. This may include, but is not limited to: - Deviations / non-conformance - procedure - Product Complaints - procedure for Handling Product Complaints - External and internal audit observations - Annual Product Reviews - Annual Product Review -

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    01 Corrective and Preventive Action CAPA V1 3 P3

    Uploaded by

    him_che1272
    434 views1 page
    This procedure will provide guidance on the requirements and use of the system as well as the procedure for processing CAPAs. The CORRECTIVE AND PREVENTIVE ACTION system assures the tracking and trending of issues requiring mid-term and long-term corrective actions. This may include, but is not limited to: - Deviations / non-conformance - procedure - Product Complaints - procedure for Handling Product Complaints - External and internal audit observations - Annual Product Reviews - Annual Product Review -

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    This procedure will provide guidance on the requirements and use of the system as well as the procedure for processing CAPAs. The CORRECTIVE AND PREVENTIVE ACTION system assures the tracking and trending of issues requiring mid-term and long-term corrective actions. This may include, but is not limited to: - Deviations / non-conformance - procedure - Product Complaints - procedure for Handling Product Complaints - External and internal audit observations - Annual Product Reviews - Annual Product Review -

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    434 views1 page

    01 Corrective and Preventive Action CAPA V1 3 P3

    Uploaded by

    him_che1272
    This procedure will provide guidance on the requirements and use of the system as well as the procedure for processing CAPAs. The CORRECTIVE AND PREVENTIVE ACTION system assures the tracking and trending of issues requiring mid-term and long-term corrective actions. This may include, but is not limited to: - Deviations / non-conformance - procedure - Product Complaints - procedure for Handling Product Complaints - External and internal audit observations - Annual Product Reviews - Annual Product Review -

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
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    of 1

    Company Name Page 3 of 8

    Department SOP No.+ Version No.

    CORRECTIVE AND PREVENTIVE Supersedes: SOP No.

    ACTION (CAPA) SYSTEM Attachments: 2 (2 pages)


    Effective date:

    1. Regulatory Basis, Reference Documents


    21CFR210, 211, 600, and 820
    2. Purpose
    The Corrective and Preventive Action (CAPA) system assures the tracking and
    trending of issues requiring mid-term and long-term corrective actions. This
    procedure will provide guidance on the requirements and use of the system as well
    as the procedure for processing CAPAs.
    3. Scope
    This system will be used to track and trend corrective and preventative actions
    planned to address known issues or to implement quality improvements. These
    requirements apply to all GMP operations and areas.

    This may include, but is not limited to:


    - Deviations/Non-conformance – Procedure
    - Product Complaints – Procedure for Handling Product Complaints
    - External and internal audit observations
    - Annual Product Reviews – Annual Product Review
    - Regulatory Issues
    - Any issues that require mid-term and long-term corrective or preventative
    action, with formal tracking and documentation
    - Recommendations of executed validations

    4. Responsibilities and Accountabilities


    4.1 Responsible Area Manager
    The manager (or his/her responsible designee) of the department where the issue is
    identified is responsible for preparing an action plan as described in this procedure.
    The Head of the area or Product/Process Team Leader of the department where the
    issue is identified is responsible for reviewing and approving the plan by signoff. The
    Head of the department is responsible for ensuring adequate support to complete
    the actions according to the approved plan.

    4.2 Quality Assurance


    Quality Assurance (QA) is responsible for issuing a CAPA number and maintaining
    the CAPA log.
    Quality Assurance (QA) representing the area where the CAPA is issued is
    responsible for handling and maintaining the official CAPA form until complete.
    Quality Assurance (QA) representing the area where the CAPA is issued is
    responsible for identifying lots that are to be placed on hold and entering these lots
    into the CAPA log.
    Contents copyrighted © GMP-ONLINE-CONSULTANCY.COM
    Reproduction, photocopying, storage or transmission by magnetic or electronic means strictly prohibited. Authorization to photocopy
    items for internal or personal use is granted by GMP-Online-Consultancy. Violation of copyright will result in legal action, including civil
    and/or criminal penalties, and suspension of service.

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