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  • GMP Record QA

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    Royal Aircon
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    This document contains a checklist for quality assurance documentation. It lists various master documents, logs, records, and reports including lists of master documents, standard operating procedures, batch manufacturing records, change control reports, equipment qualifications, and validation documents. It also includes quality management system documents like the site master file, quality manual, and documentation for inspections, deviations, complaints and HVAC validation.

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    GMP-Record-QA-

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    This document contains a checklist for quality assurance documentation. It lists various master documents, logs, records, and reports including lists of master documents, standard operating procedures, batch manufacturing records, change control reports, equipment qualifications, and validation documents. It also includes quality management system documents like the site master file, quality manual, and documentation for inspections, deviations, complaints and HVAC validation.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
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    7 views1 page

    GMP Record QA

    Uploaded by

    Royal Aircon
    This document contains a checklist for quality assurance documentation. It lists various master documents, logs, records, and reports including lists of master documents, standard operating procedures, batch manufacturing records, change control reports, equipment qualifications, and validation documents. It also includes quality management system documents like the site master file, quality manual, and documentation for inspections, deviations, complaints and HVAC validation.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
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    of 1

    QUALITY ASSURANCE

    Check points Yes No NA


    1.0 MASTER DOCUMENTS
    1.1 List of Master documents
    1.2 List of Master SOps
    1.3 List of Master BMR
    1.4 List of Master BPR
    1.5 List master Product Specification
    1.6 List master Product STP
    1.7 Logbook of Issuance records of Control documents
    1.8 Logbook of Issuance records of un-control documents
    1.9 Logbook of Destruction record of documents
    1.10 Training Records of QA employees
    1.11 Logbook of Issuance records of BMR
    1.12 Logbook of Issuance records of BPR
    1.13 Logbook of Issuance records of Format
    1.14 Issuance records of Logbooks
    1.15 List of Validation Documents
    1.16 List Of AHU
    2.0 Quality Management System Documents
    2.1 Site Master File
    2.2 Validation Master Plan
    2.3 Quality Manual
    2.4 Equipment’s Qualification
    2.5 Process Validation Report
    2.6 Cleaning Validation Report
    2.7 Change Control Report and Logbook
    2.8 Deviation Records and Logbook
    2.9 Incident Records and Logbook
    2.10 Out Of Specification and Logbook
    2.11 Self-Inspection Report and Logbook
    2.12 Annual Product review and Logbook
    2.13 Market Complain Report and Logbook
    2.14 HVAC Validation Report
    2.15 Re-validation and re-qualification report

    Page 1 of 1

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