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    Yield and Recon

    Uploaded by

    Prince Moni
    This document provides a procedure for calculating reconciliation and yield percentages during drug manufacturing and packaging. Reconciliation is calculated by accounting for all material used in production. Yield is the quantity of product physically produced, calculated as a percentage of the batch size. The procedure specifies acceptable yield percentages of at least 98% for granulation, 96.5% for compression, and 96% for packaging.

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    Yield and Recon

    Uploaded by

    Prince Moni
    1K views1 page
    This document provides a procedure for calculating reconciliation and yield percentages during drug manufacturing and packaging. Reconciliation is calculated by accounting for all material used in production. Yield is the quantity of product physically produced, calculated as a percentage of the batch size. The procedure specifies acceptable yield percentages of at least 98% for granulation, 96.5% for compression, and 96% for packaging.

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    Yield and Recon

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    This document provides a procedure for calculating reconciliation and yield percentages during drug manufacturing and packaging. Reconciliation is calculated by accounting for all material used in production. Yield is the quantity of product physically produced, calculated as a percentage of the batch size. The procedure specifies acceptable yield percentages of at least 98% for granulation, 96.5% for compression, and 96% for packaging.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    1K views1 page

    Yield and Recon

    Uploaded by

    Prince Moni
    This document provides a procedure for calculating reconciliation and yield percentages during drug manufacturing and packaging. Reconciliation is calculated by accounting for all material used in production. Yield is the quantity of product physically produced, calculated as a percentage of the batch size. The procedure specifies acceptable yield percentages of at least 98% for granulation, 96.5% for compression, and 96% for packaging.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 1

    Procedure for calculating reconciliation and yield during the

    manufacturing and packaging of the drug products.


    1.0. OBJECTIVE:
    To provide procedure for calculating reconciliation and yield during the manufacturing and
    packaging of the drug products.
    2.0. SCOPE:
    This procedure is applicable for calculation of the % reconciliation and % yield of the drug
    products.
    3.0. RESPONSIBILITY:
    3.1. Manufacturing and packaging personnel are responsible for calculation of the yield and
    reconciliation.
    3.2. QA personnel are responsible for verifying the calculation.
    4.0. PROCEDURE:
    4.1. % Reconciliation: Accounting of the material used in the manufacturing and packaging.
    4.2. The formula is
    % Reconciliation = Qty. Used + Qty. Returned + Samples + Others x 100
    Qty. Issued
    4.3. % Yield: Quantity physically produced or manufactured at the end of the operation.
    % Yield = Qty. manufactured x 100
    Qty. Issued (Batch Size)
    4.4. Reconciliation and yield shall be calculated in percentage.
    4.5. The specification for reconciliation and yield calculation is as follow:
    Stage % Yield
    (At the end of the
    stage)
    Granulation NLT 98%
    Compression NLT 96.5%
    Packaging NLT 96.00%
    5.0. ANNEXURE:
    Nil
    6.0. REFERENCES:
    7.0. ABBREVIATION :
    Abbreviation used Full form of abbreviation used
    SOP Standard Operating Procedure
    QA Quality Assurance
    QAD Quality Assurance Department
    QTY Quantity
    % Percentage
    8.0. DISTRIBUTED TO:
    Quality Assurance
    Manufacturing
    9.0. REVISION HISTORY:
    Revision Change Control Reason for the Modifications
    Number

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