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    MQA203T

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    Ashima
    This course covers the auditing process for pharmaceutical industries. It aims to help students understand the importance and methodology of auditing, and how to conduct an audit and prepare an audit report. The course contents include introduction to auditing objectives, planning, and classifications of deficiencies. It also covers auditing of vendors, production departments, microbiological laboratories, quality assurance, and engineering departments.

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    MQA203T

    Uploaded by

    Ashima
    225 views1 page
    This course covers the auditing process for pharmaceutical industries. It aims to help students understand the importance and methodology of auditing, and how to conduct an audit and prepare an audit report. The course contents include introduction to auditing objectives, planning, and classifications of deficiencies. It also covers auditing of vendors, production departments, microbiological laboratories, quality assurance, and engineering departments.

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    This course covers the auditing process for pharmaceutical industries. It aims to help students understand the importance and methodology of auditing, and how to conduct an audit and prepare an audit report. The course contents include introduction to auditing objectives, planning, and classifications of deficiencies. It also covers auditing of vendors, production departments, microbiological laboratories, quality assurance, and engineering departments.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    225 views1 page

    MQA203T

    Uploaded by

    Ashima
    This course covers the auditing process for pharmaceutical industries. It aims to help students understand the importance and methodology of auditing, and how to conduct an audit and prepare an audit report. The course contents include introduction to auditing objectives, planning, and classifications of deficiencies. It also covers auditing of vendors, production departments, microbiological laboratories, quality assurance, and engineering departments.

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    © All Rights Reserved
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    of 1

    GUJARAT TECHNOLOGICAL UNIVERSITY

    M.Pharm
    PHARMACEUTICAL QUALITY ASSURANCE
    SEMESTER: I
    Subject Name: AUDITS AND REGULATORY COMPLIANCE
    Subject Code: MQA203T

    Scope: This course deals with the understanding and process for auditing in pharmaceutical industries. This
    subject covers the methodology involved in the auditing process of different in pharmaceutical industries.

    Objectives: Upon completion of this course the student should be able to


    1. To understand the importance of auditing
    2. To understand the methodology of auditing
    3. To carry out the audit process
    4. To prepare the auditing report
    5. To prepare the check list for auditing

    Sr Course Contents Total Hrs


    No
    1 Introduction: Objectives, Management of audit, Responsibilities, Planning 12
    process, information gathering, administration, Classifications of
    deficiencies
    2 Role of quality systems and audits in pharmaceutical manufacturing 12
    environment: cGMP Regulations, Quality assurance functions, Quality
    systems approach, Management responsibilities, Resource, Manufacturing
    operations, Evaluation activities, Transitioning to quality system approach,
    Audit checklist for drug industries
    3 Auditing of vendors and production department: Bulk Pharmaceutical 12
    Chemicals and packaging material Vendor audit, Warehouse and weighing,
    Dry Production: Granulation, tableting, coating, capsules, sterile production
    and packaging
    4 Auditing of Microbiological laboratory: Auditing the manufacturing process, 12
    Product and process information, General areas of interest in the building raw
    materials, Water, Packaging materials
    5 Auditing of Quality Assurance and engineering department: Quality 12
    Assurance Maintenance, Critical systems: HVAC, Water, Water for Injection
    systems, ETP

    REFERENCES:
    1. Compliance auditing for Pharmaceutical Manufacturers. Karen Ginsbury and Gil Bismuth,
    Interpharm/CRC, Boca Raton, London New York, Washington D.C
    2. Pharmaceutical Manufacturing Handbook,Regulations and Quality by Shayne Cox Gad. Wiley-
    Interscience, A John Wiley and sons, Inc., Publications
    3. Handbook of microbiological Quality control. Rosamund M.Baird, Norman A.Hodges,StephenP.
    Denyar.CRC Press.2000
    4. Laboratory auditing for quality and regulatory compliance. Donald C. Singer, Raluca-loana
    Stefan, Jacobus F. Van Staden. Taylor andFrancis (2005).

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