Course Certificate

Svetlana A completed this course and earned a Pharmuni certificate.

Performing Phase of GMP Equipment Qualification

Pharmuni Course Certificate

ISO 9001

Quality Management System

Certificate Registration No.: 12 100 60610 TMS

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ISO 9001
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About the Performing Phase of GMP Equipment Qualification

Performing Phase of GMP Equipment Qualification explains how qualification plans are executed in practice to confirm that GMP equipment is installed correctly, operates as intended, and performs reliably under routine conditions. This course focuses on the performing stage of GMP equipment qualification and shows how execution, testing, documentation, calibration, deviation handling, and collaboration support successful qualification outcomes.
You will gain a practical understanding of how qualification work moves from planning into action. The course explores the execution of IQ, OQ, and PQ, the role of equipment classes in shaping qualification activities, protocol development and execution, detailed reporting, deviation management with CAPA, calibration of supporting tools, and collaboration with manufacturers to resolve challenges and improve qualification performance.
The course focuses on key aspects of performing GMP equipment qualification in practice, including:
    • Executing IQ, OQ, and PQ activities according to GMP requirements
    • Applying qualification plans to different equipment classes
    • Developing, executing, and documenting qualification protocols
    • Managing deviations, calibration needs, and manufacturer collaboration
Through structured explanations and practical examples, this course helps learners understand how qualification is performed in a controlled, traceable, and audit-ready way. It is best suited to professionals involved in validation, engineering, quality assurance, equipment qualification, or GMP manufacturing support.

Learning Objectives

By the end of this course, you will be able to:

  • Learning Objective 1

    Execute equipment qualification plans according to GMP standards and equipment classes (A, B, C)

  • Learning Objective 2

    Perform and document test protocols, ensuring coordination with trained staff and external technicians.

  • Learning Objective 3

    Analyze qualification data to identify deviations and implement corrective and preventive actions.

  • Learning Objective 4

    Prepare detailed qualification reports, including proper handling of attachments and calibration certificates.

  • Learning Objective 5

    Ensure the calibration and accurate use of supporting tools, such as temperature sensors during temperature mapping.

  • Learning Objective 6

    Collaborate effectively with equipment manufacturers to resolve challenges and optimize the qualification process.