A Practical Approach to Pharmaceutical Commissioning and Qualification - A Symbiotic Relationship

Timothy D. Blackburn, MBA, P.E.

Course Outline

An initial response to the recommendation to do Pharmaceutical Commissioning is that it is just an additional step - another roadblock to engineering success and something repeated during Qualification. However, effective Commissioning supports engineering and Qualification success. This course addresses efficient Commissioning techniques and synergizing with Qualification. Examples presented are not all definitive, and documentation may exceed or not include certain elements - Commissioning (and Qualification) must be structured for the project. This course contains much of the material basic Commissioning course, but focuses on the Pharmaceutical industry and recent initiatives at Commissioning. The Author has been a leader in the Pharmaceutical industry in the application of documented Commissioning to minimize the regulated paperwork required for Validation/Qualification. He shares his learned experiences in this course in the practical application of commissioning as it specifically relates to Pharmaceutical projects. (Note: See the course entitled "Commissioning Fundamentals and a Practical Approach" for a cost efficient method to apply Commissioning also.)

Commissioning as it relates to the Pharmaceutical industry is examined. Include are discussions on the following:

• Commissioning streamlines Qualification;
• Validation/Commissioning: the Distinctions;
• The "W" Model;
• InVEST Wisely in Commissioning;
• Establishing Commissioning and Documentation Requirements;
• Enhanced Commissioning;
• FAT/SAT Considerations;
• Commissioning Test Plans;
• Impact Assessments;
• SMART Commissioning and Qualification Acceptance Criteria/Ranges; and
• Specific Examples/Approaches
  

This course includes a multiple choice quiz at the end, which is designed to enhance the understanding of the course materials.

Learning Objective

At the conclusion of this course, you will:

• Learn how Commissioning can benefit Qualification;
• Learn how to synergize Commissioning with Qualification;
• Understand the definitions of and the differences between Validation and Commissioning;
• Understand the distinction of Qualification versus Validation;
• Know what is IQ/OQ/PQ;
• Learn about the "W" Model?
• Understand how Commissioning supports and benefits Qualifications;
• Learn practical acrostics InVEST - learn how to deliver effective and efficient Commissioning;
• Learn practical acrostic SMART - learn to assign practical acceptance criteria;
• Understand the primary commissioning documents/vehicles and when to use them;
• Learn about the Commissioning Documentation hierarchy;
• Learn about Enhanced Commissioning to reduce the Qualification regimen;
• Learn about Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT);
• Learn about Self-Contained Commissioning Checklists useful for small projects;
• Review GMP Impact Assessments;
• Learn typical ranges to be considered for design and acceptance criteria
  

Intended Audience

This course is intended for all engineering disciplines, especially those involved in Commissioning for projects and are interested in or work on Pharmaceutical projects. As well, Architects, Contractors, and Owners will benefit.

Benefit to Attendees

This course explains Commissioning as it relates to the Pharmaceutical industry, and offers practical approaches. The Attendee should be better able to implement effective and efficient commissioning, which offers better first-time start-up and reduced "after-the-fact" problems in projects, as well as supports lower cost/more efficient Qualification.

Course Introduction

Commissioning is an essential step in delivering a project, and is even more crucial for regulated industries such as Pharmaceuticals. Without it, we cannot have assurance of a quality outcome. This course offers an overview specific to the Pharmaceutical industry.

Course Content

The course content is in a PDF file (86 KB) A Practical Approach to Pharmaceutical Commissioning and Qualification - A Symbiotic Relationship . You need to open or download this document to study this course.

Course Summary

Commissioning Documentation and Qualification are symbiotic when properly applied. Qualification helps define what is important for Commissioning to emphasize, while Commissioning minimizes the Validation effort and supports its success. Remember to "InVEST" wisely (Integrate Commissioning with Qualification, Verify, Ensure Qualification Success, Sensible, Traceable/Document it) and set SMART Acceptance Criteria in the beginning (Sensible, Maintainable, Accurate, Range, Traceable). To get more information, see various trade organizations (ASHRAE, etc.). Tried and tested GEP approaches and documents are available, and translate easily into documented GEP Commissioning and Enhanced Commissioning. Of course, ISPE has many publications available, including the excellent "Commissioning and Qualification" Baseline guide. But mostly, learn by doing it!

Quiz

Once you finish studying the above course content, you need to take a quiz to obtain the PDH credits.

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DISCLAIMER: The materials contained in the online course are not intended as a representation or warranty on the part of PDH Center or any other person/organization named herein. The materials are for general information only. They are not a substitute for competent professional advice. Application of this information to a specific project should be reviewed by a registered architect and/or professional engineer/surveyor. Anyone making use of the information set forth herein does so at their own risk and assumes any and all resulting liability arising therefrom.

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