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    Helix Pharma (Private) Limited: Validation Protocol

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    ziauddin bukhari
    This validation protocol outlines performance qualification of three air showers. It details objectives to qualify air shower performance, equipment details, responsibilities of roles in reviewing the protocol, and a functional test to check HEPA filter integrity. Upon verification, a conclusion will determine if equipment has been qualified successfully based on a performance qualification report from a third party vendor.

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    © All Rights Reserved
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    Helix Pharma (Private) Limited: Validation Protocol

    Uploaded by

    ziauddin bukhari
    778 views4 pages
    This validation protocol outlines performance qualification of three air showers. It details objectives to qualify air shower performance, equipment details, responsibilities of roles in reviewing the protocol, and a functional test to check HEPA filter integrity. Upon verification, a conclusion will determine if equipment has been qualified successfully based on a performance qualification report from a third party vendor.

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    PQ protocol Air shower

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    This validation protocol outlines performance qualification of three air showers. It details objectives to qualify air shower performance, equipment details, responsibilities of roles in reviewing the protocol, and a functional test to check HEPA filter integrity. Upon verification, a conclusion will determine if equipment has been qualified successfully based on a performance qualification report from a third party vendor.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    778 views4 pages

    Helix Pharma (Private) Limited: Validation Protocol

    Uploaded by

    ziauddin bukhari
    This validation protocol outlines performance qualification of three air showers. It details objectives to qualify air shower performance, equipment details, responsibilities of roles in reviewing the protocol, and a functional test to check HEPA filter integrity. Upon verification, a conclusion will determine if equipment has been qualified successfully based on a performance qualification report from a third party vendor.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 4

    HELIX PHARMA (PRIVATE) LIMITED

    VALIDATION PROTOCOL
    Document # VP/PRD/EQP-PQ-045
    TITLE: Issue # 01
    Effective Date 12-05-2020
    PERFORMANCE QUALIFICATION OF AIR SHOWER Review Date 12-05-2024
    Supersede # 00
    Page 1 of 4
    PREPARED BY: APPROVED BY:

    REVIEWED BY:

    A.M. QA Director Regulatory


    Affairs & QA

    _______________ _____________ _________________


    Production Manager Senior Manager QA GM Engineering GM Quality Operation

    TABLE OF CONTENTS
    Sectio
    Description Page No.
    n
    1.0 Objectives 2
    2.0 Scope 2
    3.0 Responsibilities 2
    4.0 Equipment details 2
    5.0 Performance qualification specification 3
    6.0 Summary and conclusion 3
    HELIX PHARMA (PRIVATE) LIMITED
    VALIDATION PROTOCOL
    Document # VP/PRD/EQP-PQ-045
    TITLE: Issue # 01
    Effective Date 12-05-2020
    PERFORMANCE QUALIFICATION OF AIR SHOWER Review Date 12-05-2024
    Supersede # 00
    Page 2 of 4
    PREPARED BY: APPROVED BY:

    REVIEWED BY:

    A.M. QA Director Regulatory


    Affairs & QA

    _______________ _____________ _________________


    Production Manager Senior Manager QA GM Engineering GM Quality Operation

    1.0 OBJECTIVE:
    Purpose of performance qualification is to ensure and qualify the performance of Air
    shower.

    2.0 SCOPE:
    This performance qualification protocol is applicable to air shower in sterile area.

    3.0 RESPONSIBLITIES:
    3.1 QA responsible for generating the PQ protocol.
    3.2 QA, QC, Production, Engineering are responsible for reviewing the protocol.
    3.3 Director RA & QA responsible for approval of protocol.

    4.0 EQUIPMENT DETAILS:


    Air shower is a fully self-contained unit. They are fully equipped to provide complete de-
    contamination solutions to the clean room or manufacturing/assembly area from
    personnel entering the space.
    Three Air showers has been purchased and their details are mentioned below:

    Item Item Quantit PO No. Vendor Manufacturer


    code Name y
    FA-PMC- Air shower 03 13300581 Technocratic Shanzhen Xiangnan
    0152 services High-Tech Purify
    Equipment Co, Ltd.
    Hong Kong.
    HELIX PHARMA (PRIVATE) LIMITED
    VALIDATION PROTOCOL
    Document # VP/PRD/EQP-PQ-045
    TITLE: Issue # 01
    Effective Date 12-05-2020
    PERFORMANCE QUALIFICATION OF AIR SHOWER Review Date 12-05-2024
    Supersede # 00
    Page 3 of 4
    PREPARED BY: APPROVED BY:

    REVIEWED BY:

    A.M. QA Director Regulatory


    Affairs & QA

    _______________ _____________ _________________


    Production Manager Senior Manager QA GM Engineering GM Quality Operation
    HELIX PHARMA (PRIVATE) LIMITED
    VALIDATION PROTOCOL
    Document # VP/PRD/EQP-PQ-045
    TITLE: Issue # 01
    Effective Date 12-05-2020
    PERFORMANCE QUALIFICATION OF AIR SHOWER Review Date 12-05-2024
    Supersede # 00
    Page 4 of 4
    PREPARED BY: APPROVED BY:

    REVIEWED BY:

    A.M. QA Director Regulatory


    Affairs & QA

    _______________ _____________ _________________


    Production Manager Senior Manager QA GM Engineering GM Quality Operation

    5.0 PERFORMANCE QUALIFICATION SPECIFICATION


    5.1 Functional test for performance: HEPA filter integrity test
    Objective
    Pre-requisites
    Procedure
    Test results
    Acceptance criteria
    Deviation

    Checked by: Name: Sign:

    Designation: Date:

    Verified by: Name: Sign:

    Designation: Date:

    6.0 CONCLUSION AND SUMMARY


    The performance qualification of Air shower has been performed by Third party vendor
    “TBM Associate”. The PQ report demonstrates that equipment has been/ has not been
    qualified successfully and correctly.

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