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    SOP On Packaging and Labeling Operations

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    Yousif
    This standard operating procedure outlines guidelines for packaging and labeling operations during drug manufacturing. It applies to production chemists and operating staff and aims to prevent mix-ups and cross contamination during labeling. Key steps include identifying drug products with a lot number to track manufacturing history, examining packaging and labeling materials for correctness before use, and inspecting facilities between operations to ensure no leftover materials remain.

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    SOP On Packaging and Labeling Operations

    Uploaded by

    Yousif
    3K views2 pages
    This standard operating procedure outlines guidelines for packaging and labeling operations during drug manufacturing. It applies to production chemists and operating staff and aims to prevent mix-ups and cross contamination during labeling. Key steps include identifying drug products with a lot number to track manufacturing history, examining packaging and labeling materials for correctness before use, and inspecting facilities between operations to ensure no leftover materials remain.

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    SOP on Packaging and Labeling Operations

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    SOP on Packaging and Labeling Operations

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    This standard operating procedure outlines guidelines for packaging and labeling operations during drug manufacturing. It applies to production chemists and operating staff and aims to prevent mix-ups and cross contamination during labeling. Key steps include identifying drug products with a lot number to track manufacturing history, examining packaging and labeling materials for correctness before use, and inspecting facilities between operations to ensure no leftover materials remain.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    3K views2 pages

    SOP On Packaging and Labeling Operations

    Uploaded by

    Yousif
    This standard operating procedure outlines guidelines for packaging and labeling operations during drug manufacturing. It applies to production chemists and operating staff and aims to prevent mix-ups and cross contamination during labeling. Key steps include identifying drug products with a lot number to track manufacturing history, examining packaging and labeling materials for correctness before use, and inspecting facilities between operations to ensure no leftover materials remain.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 2

    SOP on Packaging and Labeling Operations

    1.0 Purpose: This SOP describes the guidelines for packaging and labeling operations for

    manufacture of a drug batch

    2.0 Scope: This SOP applies to Production Chemist and operating staff.

    3.0 Responsibility: Production Chemist to ensure that procedure is followed.

    4.0 Materials and Equipment: As required.

    5.0 Procedure: The procedures are designed to assure that correct labeling and packaging

    materials are used for drug products. These procedures incorporate the following features

    – 

    5.1 Prevention of mix-ups and cross contamination by physical or spatial separation from

    operations on other products.

    5.2 Identification and handling of filled drug product containers that are set aside and

    held in unlabeled condition for future labeling operations to preclude mislabeling of

    individual containers, lots, or portions of lots. Identification need not to be applied to

    each individual container but it is sufficient to determine name, strength, quantity of

    contents, and lot or control number of each container.


    5.3 Identification of drug product with a lot or control number that permits determination

    of history of manufacture and control of batch.

    5.4 Examination of packaging and labeling materials for suitability and correctness

    before packaging operations, and documentation of such examination in batch production

    record.

    5.5 Inspection of packaging and labeling facilities immediately before use to assure that

    all drug products have been removed from previous operations. Inspection is also made to

    assure that packaging and labeling materials not suitable for subsequent operations have

    been removed. Results of inspection are documented in batch production records

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