March / April 2022

Message from the Chair: ISPE News, & More

Jörg Zimmermann
Jörg Zimmermann

Pandemic or no pandemic, the pharmaceutical industry is growing at an unprecedented pace, and it is very gratifying to be part of that process. COVID-19 has brought our industry to the daily news, and while the public is getting a better grasp of how we work and need to work, there are still so many misconceptions that need clarification.

You might have heard people say that “The vaccines have been developed so quickly, nobody knows what the long-term effects really are.” We in the industry know that the fast development was only possible because of the foundational work that was done over the last 20 years. With a different risk profile, pharma companies and regulatory agencies worked hand in hand to move as fast as possible, working in parallel instead of sequentially, which is how the vaccines made it to conditional approval and widespread use in record time. The misconception here is the belief that development of medicines takes so long because long-term effects are being studied. That’s just not true. There is still so much educational work to be done.

Together Again

After the virtual ISPE Annual Meeting & Expo in 2020, the ISPE family was able to come together for a hybrid Annual Meeting that offered either in-person attendance in Boston or virtual attendance from 31 October–3 November 2021. The level of interaction in the plenary and education sessions, the exhibit hall, and the social activities was excellent. In-person attendees were so happy to be face-to-face again and to interact.

We in the industry know that the fast development was only possible because of the foundational work that was done over the last 20 years.

The 2022 ISPE Aseptic Conference is happening on 14–15 March, maybe even as you are reading this column. I am very proud to be the Chair of the program committee, and together with my Co-Chair Christa Meyers from CRB and the whole team, we have been working year-round to bring you the latest and greatest in aseptic processing. We are especially proud to have very distinguished keynote speakers from regulatory agencies and industry: Paul Gustafson from Health Canada and incoming chair of Pharmaceutical Inspection Co-operation Scheme (PIC/S) will be talking about international regulatory harmonization, Alonza Cruze of the US FDA will provide insights into the FDA’s learnings from remote assessments, and Joyce Hansen, SVP Sterility Assurance at Janssen Pharmaceuticals, is going to talk about the latest developments while also touching on how we can nurture our future leaders in the pharmaceutical industry. As always, another highlight of the conference will be the interactive panel discussion with the regulators, where you can get your questions answered and get into a real dialogue and discussion with FDA and other agencies. Both industry and regulators profit tremendously from this dialogue.

Final preparations are being made for the ISPE Europe Annual Conference in Madrid, Spain, on 25–27 April 2022.

Upcoming Activities

Final preparations are being made for the 2022 ISPE Europe Annual Conference in Madrid, Spain, on 25–27 April 2022. The conference will also be virtual. We are looking forward to connecting with our members, volunteers, and sponsors for this signature conference. Speakers include representatives from European pharmaceutical companies and regulatory agencies, covering all the hot topics in the pharmaceutical industry: Annex 1 and aseptic processing, GAMP®, Pharma 4.0™, advanced therapeutic medicinal products (ATMPs), and automation and robots.

ISPE International has two major projects going on at the moment. A lot of work went into the One ISPE initiative, which redefines the relationship between ISPE International and the ISPE Chapters and Affiliates. The overarching goal of growing ISPE in all corners of the world will be achieved by next-level collaboration and support between International and Chapters and Affiliates and directly between Chapters and Affiliates. This includes the initiatives to bring students to ISPE and help them find their way in the industry. After approval of the charter regulating the relationships, we are on a good path to have this signed by all Chapters and Affiliates. What a great achievement, and a big thanks to all involved with running the project, providing input and comments, and negotiating the best way forward!

In February, the International Board of Directors conducted a two-day workshop on the Strategic Plan for ISPE for 2023–2025. Most initiatives in the existing Strategic Plan have already been implemented, and those that continue to be key topics need to be adapted to the industry’s changing needs. This project is also on a good path, with the results to be officially unveiled at the 2022 ISPE Annual Meeting & Expo in Orlando. This is yet another signature event that you cannot afford to miss!

Celebrating GAMP®

The theme of this issue of Pharmaceutical Engineering® is GAMP. ISPE has been the home of the GAMP community since its early days. After celebrating GAMP’s 30th anniversary in 2021, this issue continues to cover the hot topics in the field.

Open-source software has helped democratize the development of applications, but also introduces additional risks. How can open-source software be used in regulated GxP systems? The many opportunities of the technology are discussed in this issue. Also in this issue is a report on an industry-specific artificial intelligence (AI) maturity model for validation developed by the ISPE D/A/CH (Germany, Austria, and Switzerland) Affiliate Working Group on AI Validation. We also continue our exploration of software as a service (SaaS) with a look at quality agreements for SaaS solutions intended for GxP use.

As you can see, our subject matter experts provide cutting-edge insights into the latest developments.

It makes me very proud to announce the Second Edition of GAMP® 5, which went out for industry peer review in January. GAMP 5 Guide–A Risk-Based Approach to Compliant GxP Computerized Systems was published in 2008. A GAMP 5 Second Edition has been developed based on comprehensive reviews of GAMP 5 content performed in 2017 and early 2020 by the GAMP CoP Global Steering Committee and the GAMP CoP ERB (Editorial Review Board).

The primary purpose and objective of this revision is the publication of a GAMP 5 Second Edition, which will provide updates, clarify the relationship between GAMP 5 and the GAMP® 5 Guide: Records and Data Integrity, acknowledgment of current FDA work on computer software assurance (CSA), and an updated, dynamic, and evolving set of Appendices. GAMP® 5 Second Edition is scheduled to be published this year, so watch for it!

I hope you will enjoy this issue of Pharmaceutical Engineering® magazine and you can apply the learnings from the articles to your daily work.

Stay safe and see you soon at an ISPE event around the world—in person or virtual.