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    SOP For Retesting Schedule of Raw Material (For API) Pharmaceutical Guidelines PDF

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    SOP For Retesting Schedule of Raw Material (For API) Pharmaceutical Guidelines PDF

    Uploaded by

    Mosub Al.Dirdiry
    345 views1 page

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    SOP for Retesting Schedule of Raw Material (For API) Pharmaceutical Guidelines.pdf

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    345 views1 page

    SOP For Retesting Schedule of Raw Material (For API) Pharmaceutical Guidelines PDF

    Uploaded by

    Mosub Al.Dirdiry

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
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    SOP for Retesting Schedule of Raw Material (For API) : Pharmaceutical ... https://www.pharmaguideline.com/2011/07/sop-for-retesting-schedule-of...

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    SOP for Retesting Schedule of Raw Material (For API)


    Standard operating procedure to prepare the retesting schedule for Raw Material.

    1.0 OBJECTIVE
    To ensure compliance with quality of approved raw material at regular interval during storage.

    2.0 SCOPE
    This procedure is applicable for retesting of approved raw material which is stored in the raw material store.

    3.0 RESPONSIBILITY
    3.1 Doing: Technical Assistant
    3.2 Checking: Executive/ Manager

    4.0 ACCOUNTABILITY
    Head of the Department

    5.0 PROCEDURE
    5.1 On receipt of raw material, enter retesting date on MRR and on all approved label.
    5.2 Retest due date shall not be more than the expiry date of the raw material.
    5.3 Give two years retest due date for all materials from the date of sampling.
    5.1 For the material having lower expiry date than 2 years retest period, assign the retest date for 1 year in that case.
    5.5 Receive the information from stores one month in advance for the material due for retesting.
    5.6 Sample the material for retesting as per √n+1 formula as per the list received from stores Dept and verify against previous records.
    5.7 Put the sampled stamp on the drums selected for sampling.
    5.8 Affix Retest label on each container.
    5.9 Carry out the following test for each raw material.
    Description
    L.O.D/Water content
    Chromatographic purity or similar purity test
    Assay
    pH, Acidity/Alkalinity
    6.0 Prepare a test report after analysis if it conforms to specification assign a new retest due date on the approved label.
    6.1 If the material fails, initiate the disposition of the material after due scrutiny by concerned authorities.
    Related: SOP for Collection and Storage of Retained Samples of Raw Material

    6.2 ABBREVIATION
    6.1 L.O.D = Loss on drying
    6.2 Q.C. = Quality Control
    6.3 GRN = Good Receipt note
    6.4 Dept = Department

    Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read
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