September / October 2022

Message From the Chair: Heading Toward a New Annex 1 and ISPE Annual Meeting

Jörg Zimmermann
Message From the Chair - Jörg Zimmermann

Summer is over and we are all back to our workplaces. This year has been different than the two previous years with vaccination against SARS-CoV 2 decoupling the infection rates from hospitalization, intensive-care units, and fatalities. That is an unprecedented achievement in such short time, and we as the pharmaceutical industry have helped make it happen to get back to a new normal.

Travel for leisure and work has largely resumed, and at the same time, some form of mobile work has been carried over. This new flexibility helps balance work and life, but also requires a different self-discipline. How has it been for you? I have enjoyed traveling again very much, to the ISPE Europe Conference in Madrid and to universities in Germany and Austria for lectures. I was able to host the ISPE International Board of Directors at Vetter in Germany, and we visited friends and family in Italy and elsewhere. On the other hand, I was not able to spend as much time on my road bike as during the lockdowns—something has to give.

Focus on Regulatory and Quality

This issue of Pharmaceutical Engineering® magazine has regulatory trends and quality initiatives as its theme. These two areas are core to ISPE’s mission of bringing quality medicines to patients. ISPE is very active in commenting on draft regulations, both in the US and Europe, and the regulatory agencies listen to ISPE as an independent voice of the industry. Drug shortage prevention has been an area of work for the organization for about 10 years now, and it did not need the COVID-19 pandemic for our experts to be ready to show how more resilience can be built into the supply chains and to prevent shortages. With the current geopolitical situation, this continues to be of utmost importance.

Regulatory agencies listen to ISPE as an independent voice of the industry.

Annex 1 Revision

We should be holding a final version of Annex 1 in our hands now, which updates the regulations for sterile products manufacturing. This is one of the central documents for our industry. As the latest version is issued concurrently by the European Medical Agency (EMA), World Health Organization (WHO), and Pharmaceutical Inspection Co-operation Scheme (PIC/S), it will set the standards worldwide. I have personally been involved in this and in the previous revision in 2006, where we as industry were able to convince the regulators to mandate grade A air supply for the crimping process for vials, instead of going to a straight grade A classification. This is just one example where the dialogue between industry and regulators has led to an acceptable path forward for everybody. The two rounds of consultations held for this revision were done with a large group of subject matter experts from ISPE involved in the commenting.

What has transpired in the discussions is that both industry and regulators from different regions have positions that are defined by their culture and by their quality culture.

Jean-Francois Dulière, ISPE’s European Regulatory Advisor, has been leading the group, consolidating hundreds of individual comments into an ISPE position. In panel discussions with regulators from around the world at conferences and webinars, the dialogue continued and helped enhance the understanding of some of the thinking and backgrounds. It remains to be seen if the high ambition to make a global document by EMA, WHO, and PIC/S will succeed or not.

What has transpired in the discussions is that both industry and regulators from different regions have positions that are defined by their culture and by their quality culture. There is not one industry position: yes, the products need to be sterile, but the requirements are different, whether producing small-volume parenterals and biologics or filling terminally sterilized infusion bags with saline and buffer solutions. Large Pharma, biopharma, start-ups, and manufacturers of advanced therapy medicinal products (ATMPs) need to adapt to the different requirements, while maintaining quality standards.

In my experience, while regulatory convergence and harmonization are a goal, agencies will focus on different aspects. In cultures where adherence to the word of the regulations is common, a manufacturer might say, “Tell me what to do. If you tell me 5, I will do 5. If you tell me 10, I will do 10. I do not need to understand it, but I am fulfilling the requirement, so I have to be in compliance. And on the other side of the spectrum are companies that have fully embraced International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q8, Q9, and Q10. They will therefore know exactly why maybe 6, 5 is the right value, and they will have scientific data to back it up and justify why using 6, 5 will lead to the right result.

Overall, there is great consensus on the principles of Annex 1, for example, on the contamination control strategy. While it has always been the goal of aseptic processing of sterile products to keep microbial, endotoxin, and particle contamination under control, the measures taken now also need to be described in an overarching strategy document. Putting this document together, starting with a process-and-gap analysis, makes companies rethink their processes and puts them in a better position to defend their systems.

ISPE Annual Meeting

By now, your travel preparations for the 2022 ISPE Annual Meeting & Expo in Orlando, Florida, should be finalized. The committee has put together a fantastic program, covering regulatory and quality, digital transformation, manufacturing trends, supply chain optimization, therapy innovations, and many more topics.

2022 ISPE Annual Meeting & Expo

I am very much looking forward to the keynote address by Thomas Wozniewski, PhD, Takeda’s Global Manufacturing and Supply Officer. The story of a Japanese company becoming a truly global player with a number of acquisitions around the world is unique and learning about it firsthand will be most insightful.

Michael Kopcha, PhD, RPh, Director, Office of Pharmaceutical Quality, US Food and Drug Administration, will be talking about “Quality: A Key Ingredient for Stable Pharmaceutical Supply Chains” in the regulatory keynote address. In the general program, there will be sessions on everything from blockchain, aseptic processing, facilities, ATMPs to combination products. It will be difficult to choose which track to attend!

One thing I always enjoy at the Annual Meeting is the 5K, but this year, we are adding morning yoga and a golf tournament to the mix. The golf tournament will serve to collect donations to the ISPE Foundation, which means that some of the money will help students attend future events like the Annual Meeting in Las Vegas, Nevada, in 2023.

Orlando has a lot to offer besides the ISPE Annual Meeting, so why not take the opportunity to prolong your stay before or after the conference with a visit to Walt Disney World, SeaWorld Orlando, or Cape Canaveral?

I sure hope to see you in Orlando!

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