ISPE European Annual Meeting 2018 - the first day

Industry 4.0 in Pharma: Thomas Zimmer opened with this big buzzword topic the ISPE European Annual Meeting 2018 in Rome. He focused on the question what ?Industry 4.0“ could that mean for the pharmaceutical industry. Estimated 250 people followed the presentation in the executive forum of the 1st day. I made some posts today and summaries the ideas in this article.

Industry 4.0 - inspiration for the pharmaceutical industry?

The first session seems to be a more inspiring session with some good insights especially with Gunter Breitinger from Siemens, he took the participants on the journey to Industry 4.0, which includes topics about time-to-market, flexibility and qualiy: The goal for Siemens is to meet 6-Sigma! And with that goal we remember all the quality guru Deming, who promoted these and other quality goals as the basis for improvement.

For 15 years Siemens is working on this goal, now they took the hurdle of 5-Sigma. Now the processes are better than 5-Sigma but still have the goal of 6-Sigma on the agenda. This is really a longterm timeline. I wonder: Where is the pharmaceutical industry today? I guess there is there is a long way to go!

Andreas Breitinger showed an example about X-Ray testing in their manufacturing site, where they reduced 42% of the testing by using predictive analytic models. Do you have a clue how much could be saved by reducing testing in our medicinal drug manufacturing facilities? Why don‘t you start tomorrow? 

Thomas Uslaender started his talk about Industry 4.0 from the view of Fraunhofer IOSB. And gain the examples are coming from a lot of industries except pharma. When will we have the first case studies from pharma? R. Uslaender talkes about some obstacles we have to overcome when using the internet in a business environment. The presentation covered also some harmonisation initiatives in this area. This is surely a key expertise of Fraunhofer Institutes.

Roman Hipp from an automotive consulting company made the last presentation in the Industry 4.0 session - the weakest talk of the round. 

He tries to make conclusions by talking about buzzwords like agility, operational excellence, innovativeness and digitalization. A lot of promotion and less helpful information. He shows that the gros margins in the pharmaceutical industry are still very high - higher than in most industries and he is worrying about the stagnation on this high level! Worrying? I think we have other problems in the industry as we can see in the second session of the day.

He again presents no examples from the pharmaceutical industry and ignores in some cases the specific restrictions in the pharma industry. Yes we should improve the processes and factories - but we have to fulfill existing requirements like change control and deviation management and other regulatory and GMP topics - it is more complicated than some consultants from the automotive industry think (remember Deming - he worked evolutionary). Sorry to ask this question: Is this helpful for the pharma industry? The coffee break was more helpful.

Nothing new about Brexit and MRA

Arielle North (former EMA) started the 2nd session with Brexit and MRA between U.S. and EU. Unfortunately, she couldn’t make it to Rome - she presented on remote with some communication problems, but it worked.

She talked about the timeline since the Brexit vote but no new information for experts that followed the recent discussions. EMA shall be temporarily in Amsterdam in Jan 2019 and permanently in Nov 2019. The milestones can be tracked on EMA’s website.

The presentation of the MRA focused also on the established facts. No surprise.

Mass Serialization

Mass Serialization - Chances, Risks and Challenges. This was the topic of Andre Overmeyer who works for Merck as Head of Logistics. 

Overmeyer brought the participants to the shop-floor of his manufacturing site and focused on real problems in the mass serialization challenge. Counterfeiting is one of the real problems today. Up to 1 million patients die every year due to counterfeited drugs - and it is not only a Asien problem - it is present in Europe, too.

This problem triggered the mass serialization initiatives. The goal: To track each unique package through the complete supply chain. The 4 pillars of Merck’s product security approach are: Secure Supply Chain - Authentication - Verification - Integrity

The journey started in 2012 due to market needs in China. In some markets serialization is already implemented. The Merck system covers meanwhile the full supply chain. The hard work is the regulatory framework (changes) and not the technical approach, said Andre Overmeyer.

This was a great talk! Deep insight into real challenges with clear numbers and a lot of tips. Outstanding - thank you! 

And finally: ?Yes, mass serialization will meet its goals in Europe!“ This was the message of Andreas Walter, Director General of the EMVO (Euopean Medicines Verification Organisation).

The global dimension of counterfeiting is obvious - the criminals play in the global dimension. An EUIPO study showed that also in Europe 4.4% of the sales are counterfeited drugs, that means 440 million packs per year! Andreas Walter dived into the deep of the specific numbers and showed also some ?dry“ facts of the Falsified Medicines Directive (FMD).

EMVOs 4 pillars are: Safety features - Reinforcing the distribution chain - Active substances - Internet sales. ?The internet sales are the weak part of the supply chain,“ said Walter. It is a focus of the initiative.

He explained also some technical aspects like the Unique Identifier. End-to-end verification was also covered as the repository system and their architecture. Andreas Walter:?The invested money will have a high ROI.“

Two great presentation at the end of a conference day with some real highlights! Hopefully the 2nd day starts in the same way as the 1st ended. 

#ispe, #gmppublishing

19 March 2018, Rome, Thomas Peither, Maas & Peither AG, GMP-Publishing

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