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    Control Sample Destruction

    Uploaded by

    Jai Murugesh
    Control sample destruction

    Copyright:

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

    Control Sample Destruction

    Uploaded by

    Jai Murugesh
    3 views3 pages
    Control sample destruction

    Original Title

    Control sample destruction

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    © © All Rights Reserved

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    DOCX, PDF, TXT or read online from Scribd

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    Control sample destruction

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    3 views3 pages

    Control Sample Destruction

    Uploaded by

    Jai Murugesh
    Control sample destruction

    Copyright:

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

    SOP for Destruction of Controlled

    Samples
    1. OBJECTIVE
    To lay down the procedure destruction of controlled sample (Raw Material and
    Finished Product)

    2. SCOPE
    This procedure is applicable to Quality assurance and Quality Control Department

    3. RESPONSIBILITY
    • Officer QA
    • Manager QA

    4. SAFETY INSTRUCTIONS
    • All these activity shall be performed in the presence of QA supervisor.

    5. PROCEDURE
    5.1 Control sample will be taken for disposal one year after expiry as per the
    following procedure:
    5.2 Blister & Strip packed tablets and capsules
    5.2.1 The carton cover shall be depacked and content shall be defoiled and shall be
    collected in a double layer polybag.
    5.2.2 The carton/insert box etc shall be destroyed by shredding.
    5.2.3 The content (Tablet/ Capsule) shall be destroyed by dissolving in a container
    with water/crushing. These will then be poured in to the pit of ETP plant.
    5.3 Bulk packed tablets and capsules
    5.3.1 Empty the contents in a double polythene bag.
    5.3.2 The content (Tablets/ capsules) shall be destroyed as given in point 5.2.3.
    5.3.3 Bulk container shall be deshaped/ crushed and disposed in a drum/ container
    at the garbage area.
    5.3.4 The labels shall be destroyed in the shredder.
    5.4 Powder packed in laminated pouches or vials
    5.4.1 Empty the contents in a container with water than this slurry shall be poured
    into the pit of ETP plant.
    5.4.2 Pouches shall be destroyed by means of crushing in the shredder.
    5.5 Liquid packed in vials, bottles or jars
    5.5.1 Unseal the container and pour the content in water and then pour into the pit of
    ETP plant.
    5.5.2 Store the empty containers in a drum. Remove the labels and destroyed all
    batch printed packing material by shredding.
    5.6 Raw Material, Active Ingredients and Bulk Drug Substances
    5.6.1 Empty the contents in a double polythene bag.
    5.6.2 Empty the content in a container with water and then pour it in to the pit of ETP
    plant.
    5.6.3 All the activity shall be performed in the presence of QA supervisor.
    6. RELATED DOCUMENTS
    Destruction of Controlled Samples Record – Annex. I

    7. DISTRIBUTION INDEX
    Original Copy will be retained by Quality Assurance Department.

    DISTRIBUTION INDEX

    Distributed To Copy No. Received By/Date

    Quality Control Department 01 ,

    8. ABBREVIATIONS
    Q.A Quality Assurance Department
    ETP Effluent Treatment Plant

    9. REVISION HISTORY

    Revision No. Issue Date Supersedes Reason of Change / Description

    Revision No. Dated

    00 10/08/2022 00 N/A First Version

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