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    PQ Template For Students

    Uploaded by

    Yejin Jang
    This performance qualification protocol outlines a study to validate a system called "Name of system (Tag No)". The 4-page document details the purpose, scope, responsibilities, safety precautions, materials, testing procedures, acceptance criteria, deviation reporting requirements, and references for the validation study. Key personnel in charge of organizing and approving the study are listed. All test data, results, and personnel involved must be documented and attached to the final report.

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    Download as PDF, TXT or read online from Scribd

    PQ Template For Students

    Uploaded by

    Yejin Jang
    43 views4 pages
    This performance qualification protocol outlines a study to validate a system called "Name of system (Tag No)". The 4-page document details the purpose, scope, responsibilities, safety precautions, materials, testing procedures, acceptance criteria, deviation reporting requirements, and references for the validation study. Key personnel in charge of organizing and approving the study are listed. All test data, results, and personnel involved must be documented and attached to the final report.

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    PQ Template for students

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    This performance qualification protocol outlines a study to validate a system called "Name of system (Tag No)". The 4-page document details the purpose, scope, responsibilities, safety precautions, materials, testing procedures, acceptance criteria, deviation reporting requirements, and references for the validation study. Key personnel in charge of organizing and approving the study are listed. All test data, results, and personnel involved must be documented and attached to the final report.

    Copyright:

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

    PQ Template For Students

    Uploaded by

    Yejin Jang
    This performance qualification protocol outlines a study to validate a system called "Name of system (Tag No)". The 4-page document details the purpose, scope, responsibilities, safety precautions, materials, testing procedures, acceptance criteria, deviation reporting requirements, and references for the validation study. Key personnel in charge of organizing and approving the study are listed. All test data, results, and personnel involved must be documented and attached to the final report.

    Copyright:

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

    Performance Qualification Protocol No: PQ PPP-XXX

    Title: Name of system (Tag No) Page 1 of 4

    PERFORMANCE QUALIFICATION PROTOCOL

    ITEM: NAME OF SYSTEM (TAG No)

    Responsibilities Name / Title Signature Date


    Protocol Prepared by

    Protocol Reviewed by

    Protocol Approved for Execution by:

    Name Title Signature Date


    QA Department
    Performance Qualification Protocol No: PQ PPP-XXX

    Title: Name of system (Tag No) Page 2 of 4

    Table of Contents

    1.0 Introduction
    2.0 Purpose and Scope
    3.0 Responsibilities
    4.0 Data Collection and Personnel Identification
    5.0 Precautions and Safety
    6.0 Materials
    7.0 Performance Testing Procedure
    8.0 Acceptance Criteria
    9.0 Deviation Reports
    10.0 References and Related Documents
    Performance Qualification Protocol No: PQ PPP-XXX

    Title: Name of system (Tag No) Page 3 of 4

    1.0 Introduction

    This section provides background information of the purpose and scope of the performance
    qualification study.

    2.0 Purpose and Scope

    2.1 Purpose

    In this section outlines what the validation study is going to prove.

    2.2 Scope

    In this section gives the scope of the study.

    3.0 Responsibilities

    Appoint a study director who will be responsible for the organization of this study and report

    4.0 Data Collection and Personnel Identification

    All personnel authorised to perform this study must be stated on the PQ report. All test data and
    results collected must be attached to the PQ report as attachments.

    5.0 Precautions and Safety

    5.1 In this section, state the precautions to be taken for the safety of operators, equipment and
    product. Use sub-sections as necessary.

    6.0 Materials

    6.1 In this section states all materials needed for the validation study.

    7.0 Performance Testing Procedure

    7.1 Provide detailed procedures on how to perform the validation study.

    8.0 Acceptance Criteria

    8.1 Provide acceptance criteria for the parameters or characteristics of the equipment/method in
    this validation study.
    Performance Qualification Protocol No: PQ PPP-XXX

    Title: Name of system (Tag No) Page 4 of 4

    9.0 Deviation Reports

    State all deviations that occurred during the execution of this protocol.

    10.0 References and Related Documents

    List all related documents (e.g., SOPs, WIs, book, articles, batch records etc.) as detailed as
    possible related to this validation study.

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