January / February 2023

Message from the Chair: GAMP® Rings in the New Year

Michael L. Rutherford
Message from the Chair: Michael L. Rutherford

As we head into 2023, it is hard to believe that it has been four years since the COVID-19 pandemic started to impact our lives and transition us to a new normal. It is also amazing how much technology and innovation continued to advance in those four years to allow our industry to develop new vaccines and innovative products to meet the world’s challenges.

This time has also resulted in major advancements in our ability to communicate, work remotely, and share information through improvements in computerized systems and infrastructure technology. The latter are the focuses of the GAMP® Community of Practice (CoP) and the theme of this issue of Pharmaceutical Engineering®.

GAMP® is near and dear to my heart, although through my involvement in ISPE International, I know that ISPE is much more than GAMP® as demonstrated by our numerous Communities of Practice and technical conferences that highlight the amazing innovations within our industry every year. ISPE brings together a very diverse group of technical disciplines and expertise, which drives innovation within our pharma industry. These advances, not only in our industry, but in all aspects of our lives, have been heavily impacted by rapid changes in computerized systems and infrastructure capabilities and technology.

Almost everything we do these days, whether it is control systems for manufacturing equipment and technology, data acquisition, data management, data analysis, artificial intelligence and intelligent automation, supply chain management, medical devices, laboratory technology, and training and education programs, involves the use of computer and infrastructure technology and the cloud. Ensuring these systems function as intended is critical to ensuring the safety of our products and the integrity of the data we generate, which is what GAMP® is all about.

ISPE brings together a very diverse group of technical disciplines and expertise, which drives innovation within our pharma industry.

Groundbreaking GAMP

The GAMP® Community of Practice celebrated its 30th anniversary in 2021 and is one of the larger ISPE Communities of Practice. The GAMP® 5 Guide, written in 2008, has been the leading industry guidance on computerized system compliance. The guide facilitates the interpretation of regulatory requirements and promotes a system life-cycle approach based on good practices. It also emphasizes the importance of the integrity of critical records, data, and decisions, as well as those aspects affecting physical attributes of the product.

While the GAMP® 5 framework and key concepts remained appropriate, current, and unchanged, and quality risk management approaches remained in place, an incremental revision was necessary to facilitate the adoption of more recent innovations. These included such innovations as Agile methodologies, cloud computing, automated tools, blockchain, artificial intelligence and machine learning, and open source software. To address these innovations and to remain current with industry trends, GAMP® 5 Guide, 2nd Edition was released in July 2022.

In September 2022, the US Food and Drug Administration released their draft guidance on “Computer Software Assurance for Production and Quality System Software,” which described computer software assurance (CSA) and the various methods and testing activities that may be applied to establish it. (Comments on the guidance were due in November 2022; the final guidance is pending.) This guidance, which was under development for a number of years, reinforced the risk-based approach that GAMP® 5 had driven for more than 14 years.

GAMP® 5 Guide, 2nd Edition and the CSA draft guidance emphasize the use of critical thinking to strengthen the risk-based approach to computerized system life cycles, and encourage the application of patient-centric, risk-based approaches aimed at quality and safety, versus primarily compliance-driven approaches. They also focus on quality versus compliance as a critical emphasis for our industry and for ISPE because that focus ensures we are delivering safe, quality medicines and products to patients with the integrity in the data to support the use of those products. Enjoy this GAMP-themed edition of Pharmaceutical Engineering®.

The Power of Volunteering

One of our objectives in the 2023–2025 ISPE Strategic Plan is to improve the ISPE volunteer experience. ISPE is heavily dependent on our volunteers to provide technical content and resources for our members and professionals in the pharmaceutical industry in Communities of Practice, committees, Chapters, Affiliates, projects, and conferences.

When I volunteered to present at a GAMP® Forum in January 2003 and share content from a pivotal regulatory inspection, I didn’t understand the impact that decision would have on my career, the support of ISPE’s initiatives, and the influence that would have on our industry and ultimately on the patients we serve. That decision to “get involved” has led to some of the best, most rewarding, but also challenging 20 years of my ISPE life. It has helped shape my career and opened doors I had never considered. The network of industry professionals I have established, the colleagues and individuals I now call friends, the knowledge I have acquired and shared, and the impact those efforts have had on our industry and my area of expertise, are invaluable.

Yes, at times it does feel like a second full-time job as my involvement has increased with my participation on the International Board and Foundation Board, but you really get out of it what you put into it. For me, the benefits have far outweighed the time invested: a really good ROI.

The efforts of our volunteers often are not recognized outside of their specific Community of Practice, committees, Affiliates, and Chapters. So, in 2022, ISPE held a number of volunteer recognition events in conjunction with several of our key international conferences. These events celebrated the volunteers who helped ISPE provide technical resources to members and professionals in the pharmaceutical industry worldwide. The response has been very positive and provided another public opportunity to say thank you. Look for other recognition opportunities in the future as ISPE continues to improve the volunteer experience and encourages participation by our membership.

I encourage you to become an ISPE volunteer: get involved at the various levels of the organization and contribute to the future success of ISPE. You will be surprised what kind of impact it can have for you and the pharma industry.

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