Performing Phase of GMP Equipment Qualification

Performing Phase of GMP Equipment Qualification

Version 1.0

Released on 07/01/2025

An intermediate course focusing on executing GMP equipment qualification, covering test protocols, calibration, deviations, and collaboration to ensure compliance and operational reliability.

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Performing Phase of GMP Equipment Qualification

Version 1.0

Released on 07/01/2025

Performing Phase of GMP Equipment Qualification

Released on 07/01/2025

  • intermediate
  • + Certificate
  • Available on app
  • Online at your own pace
  • Shareable certificate of completion

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.

TUV Certificate

ISO 9001

Quality Management System
Certificate Registration No.: 12 100 60610 TMS
Completion with

Pharmuni Certificate

Certificates issued by

Zamann Pharma Support GmbH

a TÜV-certified company in

Personnel qualification in the field of pharmacy, medical technology and quality assurance.

Consulting service in the field of pharmacy, medical technology and quality assurance.

Your 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.

This course is included in these career paths

Discover tailored career paths designed to help you grow in the pharmaceutical industry. Whether you're just starting out or looking to specialize, find the roles, skills, and learning steps that align with your goals.

Benefits of this Course

Get valuable resources, and ISO backed certification through our assessment of your knowledge and access global jobs only for Pharmuni alumni.

  • Downloadable Resources
  • Fast-Tracked Qualification
  • Exclusive Assessment Quiz
  • Skill Tree Levelup
  • Customer Support
  • Sharable & Downloadable Certification

FAQs

This course is suitable for professionals involved in carrying out GMP equipment qualification activities. It is particularly valuable for learners working in validation, engineering, quality assurance, or manufacturing support roles where qualification execution and documentation are part of the job.

By completing this course, you will build a stronger understanding of how qualification work is performed and documented under GMP expectations. This can help you contribute more confidently to qualification execution, improve how you manage protocols and deviations, and strengthen your readiness for roles involving validation, qualification support, technical compliance, or equipment-related GMP activities.

This course introduces the key principles of performing GMP equipment qualification, including:

  • How IQ, OQ, and PQ are executed in practice
  • How qualification plans differ by equipment class
  • Test protocol development, execution, and reporting
  • Deviation management, CAPA, calibration, and manufacturer support

The course includes:

  • Structured lessons with supporting text
  • Practical examples of qualification execution and common issues
  • Explanations of IQ, OQ, PQ, CAPA, calibration, and reporting concepts
  • Visual and concept-based learning elements to support understanding
  • A certificate of completion upon successfully finishing the course

Yes, the course is fully self-paced. You can begin at any time, progress through the material at your own speed, and revisit content whenever needed while you have an active subscription.