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    Sop For BPR

    Uploaded by

    Dolly Bijani
    This SOP outlines procedures for creating, reviewing, approving, and maintaining batch production records to ensure regulatory compliance and consistency in manufacturing. The production department creates BPRs according to procedures while quality assurance reviews and approves them before release. All involved must be trained on this SOP.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd

    Sop For BPR

    Uploaded by

    Dolly Bijani
    122 views2 pages
    This SOP outlines procedures for creating, reviewing, approving, and maintaining batch production records to ensure regulatory compliance and consistency in manufacturing. The production department creates BPRs according to procedures while quality assurance reviews and approves them before release. All involved must be trained on this SOP.

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    sop for bpr

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    This SOP outlines procedures for creating, reviewing, approving, and maintaining batch production records to ensure regulatory compliance and consistency in manufacturing. The production department creates BPRs according to procedures while quality assurance reviews and approves them before release. All involved must be trained on this SOP.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    122 views2 pages

    Sop For BPR

    Uploaded by

    Dolly Bijani
    This SOP outlines procedures for creating, reviewing, approving, and maintaining batch production records to ensure regulatory compliance and consistency in manufacturing. The production department creates BPRs according to procedures while quality assurance reviews and approves them before release. All involved must be trained on this SOP.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
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    Standard Operating Procedure (SOP) for Batch Production Record (BPR)

    SOP Number: [Insert SOP Number]

    Effective Date: [Insert Effective Date]

    Review Date: [Insert Review Date]

    1.0 Purpose:

    This SOP outlines the procedures to be followed for the creation, review, approval, and maintenance
    of Batch Production Records (BPRs) to ensure consistency, accuracy, and compliance with regulatory
    requirements in the manufacturing process.

    2.0 Scope:

    This SOP applies to all personnel involved in the generation, review, approval, and maintenance of
    BPRs within [Company Name] for all manufacturing activities.

    3.0 Responsibilities:

    The Production Department is responsible for creating and maintaining BPRs.

    The Quality Assurance Department is responsible for reviewing and approving BPRs.

    The Regulatory Affairs Department is responsible for ensuring compliance with regulatory
    requirements.

    4.0 Procedure:

    4.1 Creation of BPRs:

    BPRs shall be created by the Production Department in accordance with approved manufacturing
    procedures and batch records.

    BPRs should include information on raw materials, equipment, process steps, in-process controls,
    and any deviations encountered during production.

    4.2 Review of BPRs:


    The Production Department shall review the BPR for accuracy and completeness before submitting it
    for review.

    The Quality Assurance Department shall review the BPR for compliance with cGMP (current Good
    Manufacturing Practices) regulations, accuracy, and consistency.

    4.3 Approval of BPRs:

    BPRs must be approved by the Quality Assurance Department before the batch is released for
    distribution or further processing.

    The approved BPR should be signed and dated by the authorized personnel.

    4.4 Maintenance of BPRs:

    BPRs should be maintained in a secure and controlled environment to prevent unauthorized access
    or alterations.

    BPRs should be retained as per regulatory requirements and company policies.

    5.0 Records:

    All BPRs, including any revisions or updates, must be maintained as controlled documents in
    accordance with company policies and regulatory requirements.

    6.0 Training:

    All personnel involved in the creation, review, approval, and maintenance of BPRs shall receive
    training on this SOP as part of their onboarding and ongoing training requirements.

    7.0 References:

    [List any relevant references, documents, or regulations]

    8.0 Revision History:

    [List all revisions and their respective dates]

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