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    Helix Pharma (Private) Limited: Validation Protocol

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    ziauddin bukhari
    This document outlines a validation protocol for the design qualification of a pass box. It details the objectives, scope, responsibilities, equipment details, team members, prerequisites, design and working principle, design qualification specifications, deficiency reporting, and a conclusion. The pass box is designed to maintain a Class 100/ISO-5 environment for sterile areas. The protocol verifies that the proposed pass box design is suitable for its intended sterile use through specification compliance checks.

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

    Helix Pharma (Private) Limited: Validation Protocol

    Uploaded by

    ziauddin bukhari
    345 views4 pages
    This document outlines a validation protocol for the design qualification of a pass box. It details the objectives, scope, responsibilities, equipment details, team members, prerequisites, design and working principle, design qualification specifications, deficiency reporting, and a conclusion. The pass box is designed to maintain a Class 100/ISO-5 environment for sterile areas. The protocol verifies that the proposed pass box design is suitable for its intended sterile use through specification compliance checks.

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    DQ protocol pass box

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    This document outlines a validation protocol for the design qualification of a pass box. It details the objectives, scope, responsibilities, equipment details, team members, prerequisites, design and working principle, design qualification specifications, deficiency reporting, and a conclusion. The pass box is designed to maintain a Class 100/ISO-5 environment for sterile areas. The protocol verifies that the proposed pass box design is suitable for its intended sterile use through specification compliance checks.

    Copyright:

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

    Helix Pharma (Private) Limited: Validation Protocol

    Uploaded by

    ziauddin bukhari
    This document outlines a validation protocol for the design qualification of a pass box. It details the objectives, scope, responsibilities, equipment details, team members, prerequisites, design and working principle, design qualification specifications, deficiency reporting, and a conclusion. The pass box is designed to maintain a Class 100/ISO-5 environment for sterile areas. The protocol verifies that the proposed pass box design is suitable for its intended sterile use through specification compliance checks.

    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-DQ-046
    TITLE: Issue # 01
    Effective Date 26-02-2020
    DESIGN QUALIFICATION OF PASS BOX Review Date 26-02-2024
    Supersede # 00
    Page 1 of 4
    PREPARED BY: REVIEWED BY: APPROVED BY:

    _______________ _____________ _________________


    A.M. QA Production Manager Senior Manager QA GM Engineering GM Quality Operation Director Regulatory
    Affairs & QA

    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 List of team members 2
    6.0 Design qualification pre-requisites 2
    7.0 Equipment design and principle of working 3
    8.0 Design qualification specification 3-4
    9.0 Deficiency or Corrective action report 4
    10.0 Conclusion & summary 4
    HELIX PHARMA (PRIVATE) LIMITED
    VALIDATION PROTOCOL
    Document # VP/PRD/EQP-DQ-046
    TITLE: Issue # 01
    Effective Date 26-02-2020
    DESIGN QUALIFICATION OF PASS BOX Review Date 26-02-2024
    Supersede # 00
    Page 2 of 4
    PREPARED BY: REVIEWED BY: APPROVED BY:

    _______________ _____________ _________________


    A.M. QA Production Manager Senior Manager QA GM Engineering GM Quality Operation Director Regulatory
    Affairs & QA

    1.0 OBJECTIVE:
    Purpose of design qualification is to ensure there is documented verification that the
    proposed design is suitable for the intended purpose.

    2.0 SCOPE:
    This design qualification protocol is applicable to pass boxes in sterile area.

    3.0 RESPONSIBLITIES:
    3.1 QA responsible for generating the DQ 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:


    Dynamic Pass box is designed to obtain cleanliness level complies with Class 100/ISO-5
    at rest condition and ability to sweep away contaminants generated during handling and
    to maintain the required classified conditions.

    5.0 LIST OF TEAM MEMBERS:


    Members Designation Department

    6.0 DESIGN QUALIFICATION PRE-REQUISITES


    6.1 URS of Pass box
    6.2 Purchase order
    6.3 Quotation
    6.4 Specifications
    6.5 SOPs of operation and cleaning of Pass box.
    HELIX PHARMA (PRIVATE) LIMITED
    VALIDATION PROTOCOL
    Document # VP/PRD/EQP-DQ-046
    TITLE: Issue # 01
    Effective Date 26-02-2020
    DESIGN QUALIFICATION OF PASS BOX Review Date 26-02-2024
    Supersede # 00
    Page 3 of 4
    PREPARED BY: REVIEWED BY: APPROVED BY:

    _______________ _____________ _________________


    A.M. QA Production Manager Senior Manager QA GM Engineering GM Quality Operation Director Regulatory
    Affairs & QA

    7.0 EQUIPMENT DESIGN AND PRINCIPLE OF WORKING


    Vertical air pass through window/ Dynamic pass through window- with a vertical air
    current, the wind come out from punch hole on two sides, which cause the flow in chaos
    and whirlpool easily. It has low effect to get rid of the dust and bring the rising dust into
    clean room easily. Vertical Dynamic pass through window is adopted fan, HEPA filter, and
    return wind system to compose the shower device. The fan produces a high wind speed
    which is filtered by HEPA filter. Efficiency of HEPA filter 99.99%. Then forms a high speed
    clean air current that comes out by multi-hole on top. The wind speed is more than
    22m/s. Then wind returns from the bottom of Dynamic pass through window. Due to
    vertical air current, the velocity of air current at any spot keep accordance the air current
    press down vertically likes a plunger to bring the dust particle which covers the body
    quickly.

    8.0 DESIGN QUALIFICATION SPECIFICATION

    Vendor Compliance
    S. No. Parameters URS
    Specification status
    1 Size (width x depth
    x height) internal
    2 Size (width x depth
    x height) external
    3 Material of
    construction
    4 Pre-filter
    5 HEPA Filter
    6 Quantity
    7 UV light
    8 Quantity
    9 On/off switch for
    blower
    HELIX PHARMA (PRIVATE) LIMITED
    VALIDATION PROTOCOL
    Document # VP/PRD/EQP-DQ-046
    TITLE: Issue # 01
    Effective Date 26-02-2020
    DESIGN QUALIFICATION OF PASS BOX Review Date 26-02-2024
    Supersede # 00
    Page 4 of 4
    PREPARED BY: REVIEWED BY: APPROVED BY:

    _______________ _____________ _________________


    A.M. QA Production Manager Senior Manager QA GM Engineering GM Quality Operation Director Regulatory
    Affairs & QA

    10 On/off switch for


    UV light
    11 Door handles and
    hinges

    Checked by: Name: Sign:

    Designation: Date:

    Verified by: Name: Sign:

    Designation: Date:

    9.0 DEFICIENCY AND CORRECTIVE ACTION REPORT


    (If any)

    10.0 CONCLUSION AND SUMMARY


    The design qualification of Pass box has been performed by DQ team. The specifications
    provided in URS meets/ does not meet with vendor specification. Execution of Design
    qualification states that intended purpose of proposed design has been/ has not been
    fulfilled successfully.

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