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    Sop - F-P Storage

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    kundanrana
    1) The document provides guidelines for collecting and storing finished product control samples. 2) Control samples equivalent to 200 tablets/capsules or one carton pack are collected and stored separately from the packaged batch in the retained sample room. 3) The samples are labeled "CONTROL SAMPLE - NOT FOR SALE" and stored for one year after the batch expiry to allow for quality testing if needed.

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

    Sop - F-P Storage

    Uploaded by

    kundanrana
    772 views3 pages
    1) The document provides guidelines for collecting and storing finished product control samples. 2) Control samples equivalent to 200 tablets/capsules or one carton pack are collected and stored separately from the packaged batch in the retained sample room. 3) The samples are labeled "CONTROL SAMPLE - NOT FOR SALE" and stored for one year after the batch expiry to allow for quality testing if needed.

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    sop -f-p storage

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    1) The document provides guidelines for collecting and storing finished product control samples. 2) Control samples equivalent to 200 tablets/capsules or one carton pack are collected and stored separately from the packaged batch in the retained sample room. 3) The samples are labeled "CONTROL SAMPLE - NOT FOR SALE" and stored for one year after the batch expiry to allow for quality testing if needed.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    772 views3 pages

    Sop - F-P Storage

    Uploaded by

    kundanrana
    1) The document provides guidelines for collecting and storing finished product control samples. 2) Control samples equivalent to 200 tablets/capsules or one carton pack are collected and stored separately from the packaged batch in the retained sample room. 3) The samples are labeled "CONTROL SAMPLE - NOT FOR SALE" and stored for one year after the batch expiry to allow for quality testing if needed.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    of 3

    Dr.

    Kumar’s
    Pharmaceuticals
    # 17-18, INDUSTRIAL AREA, BILASPUR (H.P.) 174001
    Department : Quality Assurance SOP No.-
    Standard Operating Procedure for Revision no.-
    Preparation of Master Formula Page no.-1 of 5
    Issue date-
    Effective Date-
    Next Review-

    Prepared By Checked By Approved By Authorized By


    Sign
    Date
    Department

    Purpose
    To provide guidelines for collection and storage of finished product control samples.
    Scope

    This SOP is applicable for collection and storage of finished products and control samples.
    Responsibility

    QA Manager & Executive QA

    General conditions

    1. The control sample should be kept in their final packaging and stored under the
    recommended conditions.

    Precautions
    1. Any withdrawal from the control sample should be registered in the control sample
    register
    (Format given below under the heading of Format of recording )
    Procedure
    1. QA Chemist should draw the samples at intervals of packaging of the product.
    2. Samples drawn at each interval should be placed separately in the place provided for
    the same.
    3. After completion of packing of the batch, pool the samples and collect units (blisters/
    strips) equivalent to 200 tablets/capsules or at least one carton pack as per Annexure
    –I
    e.g. For 10’s pack - 20 units, For 7’s pack - 29 units or for Ecosprin one carton of 25
    x 14’s

    4. The blisters/strips should be collected in over printed cartons.

    5. Paste the “ CONTROL SAMPLE – NOT FOR SALE“ sticker on carton and each
    strip/Blister, duly signed and dated.
    6. Keep the control samples on the rack as per location provided in A/c retained sample
    room. The sample should be kept from left to right direction on the rack.

    Dr. Kumar’s
    Pharmaceuticals
    # 17-18, INDUSTRIAL AREA, BILASPUR (H.P.) 174001

    Department : Quality Assurance SOP No.-


    Standard Operating Procedure for Revision no.-
    Preparation of Master Formula Page no.-3 of 5
    Issue date-
    Effective Date-
    Next Review-
    4. About 120 tablets/ filled capsules shall be collected from all the containers, which hold
    the compressed tablets/ filled capsules.
    5. The collected samples shall be pooled.
    6. After sampling, Chemist QA/Officer QA shall ensure that the containers are properly
    closed and shall affix “SAMPLED” Stamp on the status label.
    7. Chemist QA/Officer QA handover the sample to Executive QC along with technical
    information sheet & register the sample with the batch details & sampling quantity in
    Core Tablets Inward Register .
    8. Executive QC shall keep the samples in drawer labeled as “ Core, Coated tablet &
    Filled capsules for analysis”.

    Acceptance criteria
    The control samples of each batch should be retained for one year after the expiry of
    the batch.

    Frequency
    After completion of packing of every batch.

    Reason for revision


    First Edition

    Format for recording

    Control sample register

    Control sample sticker

    CONTROL SAMPLE

    NOT FOR SALE


    Sign : Date :

    RH + RT Record

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