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    Sop For Preparation of BMR

    Uploaded by

    Dolly Bijani
    This standard operating procedure outlines guidelines for preparing Batch Manufacturing Records (BMRs) to ensure consistency, accuracy, and regulatory compliance. It specifies roles and responsibilities in BMR preparation, the document control process, steps for creating BMRs including data entry and documentation, review and approval procedures, distribution and storage of BMRs, retention periods and archiving, and training requirements for personnel.

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

    Sop For Preparation of BMR

    Uploaded by

    Dolly Bijani
    349 views1 page
    This standard operating procedure outlines guidelines for preparing Batch Manufacturing Records (BMRs) to ensure consistency, accuracy, and regulatory compliance. It specifies roles and responsibilities in BMR preparation, the document control process, steps for creating BMRs including data entry and documentation, review and approval procedures, distribution and storage of BMRs, retention periods and archiving, and training requirements for personnel.

    Original Title

    SOP FOR PREPARATION OF BMR

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    This standard operating procedure outlines guidelines for preparing Batch Manufacturing Records (BMRs) to ensure consistency, accuracy, and regulatory compliance. It specifies roles and responsibilities in BMR preparation, the document control process, steps for creating BMRs including data entry and documentation, review and approval procedures, distribution and storage of BMRs, retention periods and archiving, and training requirements for personnel.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    349 views1 page

    Sop For Preparation of BMR

    Uploaded by

    Dolly Bijani
    This standard operating procedure outlines guidelines for preparing Batch Manufacturing Records (BMRs) to ensure consistency, accuracy, and regulatory compliance. It specifies roles and responsibilities in BMR preparation, the document control process, steps for creating BMRs including data entry and documentation, review and approval procedures, distribution and storage of BMRs, retention periods and archiving, and training requirements for personnel.

    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 Preparation of Batch Manufacturing Records (BMR)

    Objective: To establish guidelines for the preparation of Batch Manufacturing Records (BMR) to
    ensure consistency, accuracy, and compliance with regulatory standards.

    Scope

    This SOP applies to all personnel involved in the preparation of BMRs.

    Responsibilities

    Specify the roles and responsibilities of individuals involved in BMR preparation.

    Document Control

    Describe the document control process, including version control and approval.

    BMR Preparation

    Detail the steps for creating BMRs, including data entry, calculations, and documentation of
    manufacturing processes.

    Review and Approval

    Outline the review and approval process for BMRs, involving relevant personnel.

    Distribution and Storage

    Explain how BMRs should be distributed to production areas and stored securely.

    Retention

    Specify the retention period for BMRs and the procedures for archiving.

    Training

    Include requirements for training personnel involved in BMR preparation.

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