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    1 Quality Assurance 6th Sem PCI

    Uploaded by

    krishna

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    © All Rights Reserved
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    1 Quality Assurance 6th Sem PCI

    Uploaded by

    krishna
    6 views13 pages

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    © © All Rights Reserved

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    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    6 views13 pages

    1 Quality Assurance 6th Sem PCI

    Uploaded by

    krishna

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
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    Quality Assurance and Quality

    Management Concepts
    Definitions, concept of QC, QA and GMP

    1
    Learning Outcomes:
    The learners will be able to
    Know the various terms in Quality Assurance Subject
     Know the definitions of various terminologies in Quality
    Assurance Subject

    2
    Some Definitions

    ACTIVE PHARMACEUTICAL INGREDIENT


    (API)
    Any substance or mixture of substances intended to be
    used in the manufacture of a pharmaceutical dosage
    form and that, when so used, becomes an active
    ingredient of that pharmaceutical dosage form. Such
    substances are intended to furnish pharmacological
    activity or other direct effect in the diagnosis, cure,
    mitigation, treatment, or prevention of disease or to
    affect the structure and function of the body.

    3
    standard operating procedure (SOP)
    An authorized written procedure giving instructions for
    performing operations not necessarily specific to a given
    product or material (e.g. equipment operation, maintenance
    and cleaning; validation; cleaning of premises and
    environmental control; sampling and inspection). Certain
    SOPs may be used to supplement product-specific master and
    batch production documentation.
    starting material
    Any substance of a defined quality used in the production of a
    pharmaceutical product, but excluding packaging materials.
    validation
    Action of proving, in accordance with the principles of GMP,
    that any procedure, process, equipment, material, activity or
    4 system actually leads to the expected results (see also
    qualification).
    Quality Management (QM)
    • A quality management system is a Good Manufacturing Practices (GMP)
    management technique used to • Performance standards that WHO and
    communicate to employees what is many national governments
    required to produce the desired established for pharmaceutical
    quality of products and services and manufacturers covering, for example,
    to influence employee actions to personnel, facilities, packaging, and
    complete tasks according to the quality control.
    quality specifications.

    5
    QC INTERRELATIONSHIP

    TQM

    6
    7
    Developme DISTRIBUT
    nt ION

    Areas
    of QA
    INSPE
    QC CTION
    PRODU
    CTION
    8
    Product meets
    specifications To identify &’
    & mfd as per prepare necessary
    std. of GMP SOP’s to control
    To ensure quality
    quality policies
    adopted by a Responsibiliti
    company are es of QA
    followed
    Assess the operations
    Responsibility of continually, advise,
    quality guide for compliance of
    monitoring or internal & external
    audit function regulations

    9
    Quality assurance framework
    DOCUMENT REVIEW

    INSPECTION OF LOCAL/IMPORTED PRODUCT SAMPLES, MANUFACTURING SITES, MARKET


    PLACE

    DATA DECISION
    ANALYS MAKING &
    IS AND ENFORCEMENT
    EVALUA
    PRODUCT TESTIING
    TION

    REPORTING

    10
    DETERMINANTS
    OF
    PHARMACEUTIC
    AL QUALITY

    11
    PRACTICAL APPROACHES FOR QA

    Procedure to establish comprehensive QA program


    divided into 3:
    1. Procedures to ensure that quality standard medicine
    products are purchased. These are
    Careful product selection
    Careful supplier selection
    Certificate of analysis for each batch of product
    Certification of GMP
    Batch certification (like WHO )
    Inclusion of detailed product – quality specifications in
    contract
    12
    2. Procedures to verify that shipped goods meet
    specifications:
    Pre and post shipment inspection
    Analytical Pharmaceutical testing
    3. Procedures to monitor & maintain the quality of
    pharmaceuticals from the moment they are received
    until the medicine is finally consumed by the patient.:
    Proper storage & distribution procedures
    Appropriate dispensing
    Instructions to the patient on proper use of medication
     Product defect and pharmacovigilance reporting
    programs
    13

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