January / February 2023

Communities of Practice Focuses on the Future of Commissioning and Qualification

Marcy Sanford
Communities of Practice Focuses on the Future of Commissioning and Qualification

The Commissioning and Qualification (C&Q) CoP was one of the first Communities of Practices to be established at ISPE. One of its founding members, Steve Wisniewski, Principal Consultant, CAI, said the Communities of Practice was formed in 2004 to identify and promote more efficient approaches that resulted in pharmaceutical facilities being fit for their intended purpose.

For 2023, the Commissioning and Qualification Communities of Practice Steering Committee is focusing on paperless validation and Pharma 4.0™ as areas of interest. They also have plans to distribute a benchmarking survey early this year. “The goal of the survey is to establish an industry data source for current adoption rates for quality risk management (QRM) and integrated C&Q,” said Commissioning and Qualification Communities of Practice Chair Nathan Temple, CQV Business Area Leader, CAI. “The data set will include the cost of Commissioning and Qualification as a percentage of total installed cost (TIC) and other metrics and KPIs. Our goal is to provide industry with the baseline data and thus the rationale to support increased adoption rates for the advanced and efficient Commissioning and Qualification practices contained within the ISPE Baseline Guide Vol. 5: Commissioning & Qualification, 2nd Edition and the ISPE Good Practice Guide: Good Engineering Practice, 2nd Edition.”

“Regulatory compliant and efficient commercial pharmaceutical manufacturing operations are optimally achieved with the application of the body of knowledge available from the C&Q CoP,” said Temple. “Beginning with the original 2001 ISPE Baseline Guide: Volume 5–Commissioning and Qualification V-Model approach to the 2007 ASTM E2500 QRM-based Commissioning and Qualification life-cycle approach and supporting ICH Q8, Q9, and Q10 Guidance, and Regulatory guidance, the Commissioning and Qualification Communities of Practice has traditionally taken the lead in the transformation of qualification of facilities, systems, and equipment in support of process qualification/process validation away from retrospective execution of installation qualification and operational qualification protocols to concurrent project life-cycle execution activities.”

Information Sharing Forum

Traditionally, the Commissioning and Qualification Communities of Practice has provided a forum where regulators, industry leaders, and stakeholders can express ideas and share best practices in support of C&Q associated with the commissioning, qualification, and validation holistic process. The Communities of Practice takes a proactive approach to knowledge development and sharing in its areas of focus through the following activities:

  • Participation, as Commissioning and Qualification subject matter experts (SMEs), in related ISPE Baseline Guides and Good Practice Guides
  • Webinars of defined areas of focus
  • Pharmaceutical Engineering® articles
  • Presentations at ISPE conferences and Affiliate and Chapter events
  • Establishment of task teams with identified scopes of focus such as key deliverables associated with the quality risk management (QRM) Commissioning and Qualification process and paperless validation.
  • Technical input and review in support on the ISPE T40, QRM Commissioning and Qualification training course

As new challenges occur in the pharmaceutical industry, steering committee members will look for ways to continue to discuss and develop best practices to meet industry needs. As the pharmaceutical industry begins to embrace the opportunities presented by the concepts of digital transformation, the Commissioning and Qualification Communities of Practice is looking to provide guidance and best practices on digitization efforts in their areas. “We anticipate additional content from the paperless validation team to include best practice blog posts, initiation of a good practice guide, and collaboration with the Pharma 4.0™ Communities of Practice on a case study,” said Temple.

Benefits of Participation

Temple encourages ISPE members to get involved with the Communities of Practice by participating in the Commissioning and Qualification Communities of Practice Discussion Forum on ISPE Engage or joining a subcommittee or task team established by the steering committee. “I joined the steering committee in 2018 right as the team was finishing the revision to the ISPE Baseline Guide Vol. 5: Commissioning and Qualification, 2nd Edition. It was an exciting time and I wanted to help roll out the vision that others had so masterfully captured in this major update. We had a large group covering multiple technologies and practices; however, everyone focused on optimizing C&Q to meet the goal of equipment fit for purpose using a QRM approach. To me, there has been great value working with the CoP. It is professionally satisfying to work with such a diverse group of professionals.”

Commissioning and Qualification Steering Committee Member Jörg Block, GMP Compliance Engineer, Bayer, joined the Communities of Practice at the ISPE Annual Meeting in 2006. “At that time, developing a balanced Commissioning and Qualification process providing evidence that our facilities, installations, and equipment were fit for purpose was a big effort. Besides the EU GMP Guide Annex 15, the ISPE Baseline Guide 5 was one of the key drivers and the ICH Q9 gave the basis for the development of ASTM E2500. The draft version of ASTME 2500 was heavily discussed at the Commissioning and Qualification Steering Committee meeting and the annual meeting in November 2006. It has been a great value for me to be part of these discussions, to contribute but also to listen and learn from all the other perspectives that were shared. I very much appreciate the opportunities provided working with the Commissioning and Qualification Communities of Practice. The exchange of experiences, ideas, and results, coming to a common understanding on how to proceed and present the topics to the Commissioning and Qualification community, and to receive feedback provides a continuous improvement process. Through my involvement with the Communities of Practice, I’ve had other opportunities with ISPE to the work on guidance documents, present at conferences, and work on articles and webinars. Every experience gives me additional insight and is ultimately a benefit for my company.”

For Wisniewski, the Communities of Practice is a part of the value of ISPE membership. “I attended ISPE’s first Annual Meeting and have been a member since then,” he said. “I joined because I supported ISPE’s stated goal of supporting networking and communication between industry leaders, regulators, and those working in the pharmaceutical industry in support of the efficient manufacture of quality products. As an engineer by training, I always had a focus on manufacturing operations and the associated facilities, systems, and equipment. I realized early on that active participation in ISPE would be a benefit to me professionally and also provide an opportunity to provide a benefit to the pharmaceutical industry. Being a member of a Community of Practice is just one of the ways ISPE members can meet each other.”

About ISPE’s Communities of Practice

ISPE’s Communities of Practice are just one of the benefits available to ISPE members. “Communities of Practice (CoPs) are composed of ISPE members who share ideas, best practices, and their experience across a range of topics in the pharmaceutical industry,” Tim Postlethwaite, Director of Technical Communities, ISPE, explained. “Often, ISPE CoPs and their steering committees spearhead the generation of our gold standard content such as Good Practice Guides, Pharmaceutical Engineering articles, conference presentations, and training programs.” The continuing series of profiles of CoPs being published in Pharmaceutical Engineering recognizes the importance and contributions of CoPs to ISPE and the industry.