Commissioning & Qualification (IQ OQ PQ) of Equipment

Learn how to develop test protocols for an equipment system in a GMP regulated environment

  • Develop & write test protocols (IQ, OQ, PQ)
  • Read P&IDs, piping isometrics and loop drawings
  • Complete course from anywhere online in 10 weeks

Beginner

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Online, 10 weeks, 14 hrs / week

Price   |   Syllabus

Learn How to Develop Test Protocols for an Equipment System

What are test protocols (IQ, OQ, PQ)? How do you read P&IDs, piping isometrics and electronical loop drawings? How do you develop test protocols for an equipment system in a GMP regulated environment. In this practical hands-on workshop driven course, you will learn this and more.

Learn how to read the engineering documentation used to specify and design equipment or systems in a manufacturing facility including P&ID’s, piping isometrics and electrical loop drawings.
Design and prepare validation-testing protocols for equipment, instruments and piping systems, automation systems and building facilities.
Have a clear understanding about the design specifications that are required to generate IQ OQ PQ validaton protocols.
Develop test protocols for an equipment system in a GMP regulated environment.
Interpreting P&ID’s
Generation of IQ OQ PQ Tests
URS for an equipment system
Validation Master Plan and Varification Protocol
Component and System Impact Assessment
Testing Traceability Matrix for Equipment and System
Equipment, Instrument and Piping Checksheets
Process Control Verification
Functional Testing
Installation Qualification (IQ) Testing
Deviation and Change Control Procedures
Operational Qualification (OQ) Protocol Content

Watch Video

Watch a sample video from the course on IQ/OQ/PQ and process validation

Online Learning Done Differently

or: Why this is an Online Course You’ll Actually Finish!

Each week, you’ll complete a series of videos, quizzes, interactive activities and projects through our online platform, available to access 24/7.
Online courses can start off great, but staying motivated can be a challenge. So, you’ll get regular feedback reports (and emails or phone calls if you fall behind!) to keep you on track.
Because it’s online, there are no long commutes, traffic jams or crowded trains to deal with on the way to class. Study at home after the kids have gone to bed.
Your working schedules are unpredictable so we offer flexible delivery. Slow down, speed up or pause the delivery of the course.
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GetReskilled Success Stories
IQ OQ PQ

Edel Harkins

“I would highly recommend anyone in my situation who has been out of the industry for a period of time to do these courses. They have contributed to my new found confidence in my existing and new qualifications, my improved interview skills and my new job!”

IQ OQ PQ

Darren Deehan

“I have really enjoyed the course. The course content was very detailed and way surpassed my expectation. While the course was challenging, the online support and access was exceptional. I am really looking forward to progressing to the follow-on/specialization course, “BioValidation” when it becomes available.”

IQ OQ PQ

David Masterson

“The courses are detailed, easily accessible, great to add to your CV or to compliment other qualifications.”

Lecturer

Joe Brady
Joe Brady

Lecturer, Dublin Institute of Technology

Dr. Joe Brady is an assistant lecturer with the Dublin Institute of Technology (DIT), in the School of Chemical and Pharmaceutical Sciences. Joe is a certified trainer, and highly experienced in competency based training. He designs and prepares educational modules and full academic courses ranging from MSc, MEngSc. BSc, to Certificate level, for a range of academic institution.

He is also a supervisor for MSc/MEngSc and PhD theses. Joe has over seventeen years project experience in the pharmaceutical, biopharmaceutical and medical device industries in Ireland, Singapore, China, The Netherlands, France and the USA.

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Syllabus

Week 1 – Interpreting P&ID’s

  • Design Documents Required for the Generation of Installation and Functional Tests
  • User specification for a Reactor
  • Equipment Configuration and Process Sequence for a Reactor
  • Generation of Piping and Instrumentation Diagrams (P&ID)
  • URS for Hot Detergent and Hot PUW Generation and Distribution Skid System
  • Equipment List
  • Instrument List
  • Inline Components List

Week 2 – System Impact Assessment & Traceability Matrix

  • Protocol Content Part 1: Objective, System Description and Scope
  • System Impact Assessment
  • cGMP Testing Principles
  • Valves
  • Piping Line List
  • Testing Traceability Matrix for Equipment Systems

Week 3 – Installation Tests & Equipment Verification

  • Protocol Content – Part 2: Responsibilities and Installation Testing
  • Minimum Elements of a Test Script
  • Good Documentation and Records Management
  • Component Level Impact Assessment – Part-1 Product Contact Components
  • Installation Test P&ID Walk-Down
  • Installation Test and Equipment Verification
  • Pumps

Week 4 – Piping Isometrics & Checksheets

  • Piping Components
  • Piping Isometrics 2D P&ID and 3D CAD Images
  • Piping Isometrics and 3D CAD
  • Piping Material Traceability
  • Piping Tests
  • Heat Exchangers
  • Instrumentation Identification
  • Installation Test Piping Verification GMP-Checklist

Week 5 – Instrument Loops & Checksheets

  • Process Control
  • P&ID Instrument Identification
  • Input Output (1/O) List
  • Process Control Hardware Panels
  • Loop Signal Verification
  • Installation Test Instrument Verification
  • Proportional-Integral-Derivative Controller (PID Controller)

Week 6 – URS & Functional Testing

  • Protocol Content – Part-3 Operational/Functional Testing
  • Component Level Impact Assessment – Part-2
  • Operational Testing Primary Functions GMP Checksheet
  • Testing Traceability Matrix for Equipment System Second Pass
  • User Requirement Specifications (URS)

Week 7 – Assembling the Validation Protocol

  • Protocol Content – Part – 4: General Attachments
  • Protocol General Attachments
  • General Contents of a Validation Master Plan
  • Protocol Deviation Procedure
  • Change Control Procedure
  • Protocol Testing Template
  • Testing Traceability Matrix for Equipment System

Week 8 – Validation Protocol Final Review

  • Conclude List of Installation Tests
  • Conclude List of Functional Tests
  • Final Protocol Template Review

Complete an End of Module Assignment

Write an IQ OQ PQ protocol for a Clean-in-Place system.

Complete the Following Activities and Workshops

You will become familiar with a range of documents used in projects including piping and instrumentation diagrams (P&ID), equipment specifications, instrument specifications, line lists, piping isometrics, 3D layouts, electrical and hardware control – panel diagrams, and wiring and loop diagrams. These design documents are used to generate IQ OQ PQ commissioning and qualification protocols.

You will also become familiar with:

  • User Requirement Specifications (URS)
  • cGMP impact-assessments
  • cGMP design reviews
  • Design Qualification (DQ) reports
  • Specification and testing traceability matrices
  • Typical testing IQ OQ PQ protocol templates

Certified by GetReskilled

You will receive an end of course certificate from GetReskilled which along with others modules can build into an academic accreditation from the Dublin Institute of Technology (Ireland) subject to the following criteria;

  • Passing a written or oral Exam on the materials.
  • The submission of all assessments and the end of module assignment.

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Frequently Asked Questions

This is an advanced and high level course and is not comparable to a two day course both in the range of content covered and the detail it goes into. Furthermore, spreading the learning over 10 weeks rather than trying to cramp everything into a three day or one week event means that you will dramatically improve your retention of the materials.
This available worldwide and in certain US States. Contact us for details.

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