Scribd Logo
Upload

Welcome to Scribd!

  • 1 views

    Equipment Qualification - Copy

    Uploaded by

    rahat.pharmacy

    Copyright:

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

    Equipment Qualification - Copy

    Uploaded by

    rahat.pharmacy
    1 views10 pages

    Copyright

    © © All Rights Reserved

    Available Formats

    PPTX, PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    1 views10 pages

    Equipment Qualification - Copy

    Uploaded by

    rahat.pharmacy

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    You are on page 1of 10

    1

    Equipment Qualification
    (Advanced Pharmaceutical Technology)
    Ph.D. Pharmaceutics

    For Madam Dr. Rahat


    By Rabia Khokhar (Class of 2020)
    Introduction

    • Qualification is defined as:


    “Action of proving and documenting that any premises, systems and
    equipment are properly installed, and/or work correctly and lead to the
    expected results”

    • It is the entire process by which products are obtained from manufacturers or


    distributors, examined and tested, and then identified as a qualified product.

    2
    Objectives

    • To ensure that system/equipment installed conforms to the purchase


    specifications and the manufacturer details and literature
    • To determine that the system/equipment operates according to
    specifications
    • To determine that the systems/equipment perform as intended by
    repeatedly running the system on its intended schedules and recording all
    relevant information and data.

    Results must demonstrate that performance consistently meets pre-


    determined specifications under normal conditions, and where appropriate for
    worst case situations.
    3
    Relationship between Validation and Qualification

    • Validation and qualification are essentially components of the same concept.


    • The term qualification is normally used for equipment, utilities and systems,
    and validation for processes. In this sense, qualification is part of validation.

    4
    5
    Qualification stages

    • There are four stages of qualification


    – Design Qualification (DQ)
    – Installation Qualification (IQ)
    – Operational Qualification (OQ)
    – Performance Qualification (PQ)
    • All SOPs for operation, maintenance and calibration
    should be prepared during qualification.
    • Training should be provided to operators and training
    records should be maintained.

    6
    • Design qualification
    – Design qualification should provide documented evidence that the design
    specifications were met.

    • Installation qualification
    – Installation qualification should provide documented evidence that the installation
    was complete and satisfactory.
    – The purchase specifications, drawings, manuals, spare parts lists and vendor details
    should be verified during installation qualification.
    – Control and measuring devices should be calibrated.

    7
    8
    9
    10

    REFERENCE
     Annex 4 Supplementary guidelines on good manufacturing practices: validation
    https://www.who.int/medicines/areas/quality_safety/quality_assurance/Supplem
    entaryGMPValidationTRS937Annex4.pdf?ua=1

    You might also like