Pharma 4.0, Industrial IoT – ISPE GAMP 2018 in Warsaw

Data Integrity

Pharma 4.0, Data Integrity, Internet of Things and role of ICH in “Holistic Control Strategy”: These were the main topics of the GAMP conference titled “Automated systems”. Organized by the ISPE Polish Affiliate in Warsaw from March 14th-15th, the conference was hosted by Gerard Halski (Chairman of GAMP Poland) and Rafal Buczek (member of ISPE Poland management board)

As was to be expected with those topics and expert speakers from the pharmaceutical industry on the agenda, it was a remarkable two-day experience with lots of new insights.

Data Integrity built in the Project

Moving to Pharma 4.0 was one big focus – the idea behind it, how it currently works in Industry 4.0 and the ISPE’s approach towards Pharma 4.0.  We learnt about Holistic Strategy Control which is supposed to assure data integrity on project level, based on ICH rules. Which brings us to the concept of Digital Maturity and Data integrity by Design. The big benefit from this concept is data integrity being built-in from the very beginning of the project, thus ensuring quality and compliance.

Plug & Produce – the new Feature

Another hot topic: the Industrial Internet of Things! The audience was introduced to the term “Plug & Produce”. The idea is to adapt the Plug&Play feature, as we know it from our personal computers at home, and to apply it to the pharmaceutical industry, especially production. It simplifies, increases usability and reduces the effort of engineering implementation. It also enables end-to-end integration between equipment across various departments within the company, from Manufacturing to Laboratory/ Analytical Devices, through to LIMS and Process Control Systems. This helps to save a lot of time and effort. A Plug & Produce Guidance document is currently in preparation. A first white paper draft is targeted for end of Q1 2018.

“E”-Possibilities in MES Systems

MES – Manufacturing Execution Systems was the special focus end of day one and on day two. One interesting speech was about identifying problems around data integrity when implementing MES and electronic batch record. Interesting in this context: the “e”-possibilities in terms of reducing paper-based batch recording on production plants. Also the rules to achieve an effective electronic batch record system were considered helpful by great part of the audience, mainly professionals from CSV, Quality Assurance and Control, Manufacturing etc.

Still Vision, but exciting Goals to go for

Personally, I had this feeling that all presenters had one common opinion – there is a long way ahead of us to make these ideas a reality. Today they are still clearly a vision.

One recurrent problem that was addressed within each topic was the authorities. How can they be convinced to accept new approaches? Some went so far as to suggest that we would need to train the authorities how to perform audits and inspections with these new approaches in mind.  Who knows?

Anyway, the conclusion is that no matter how early stage we are talking about and how niche these topics still may be, it would be an amazing adventure to be part of. Being a part of ISPE and the GAMP community helps us stay up-to-date and be within the communication loop for all fresh and firsthand information. I am looking forward to this exciting journey with a great team!

by Jakub Grzanka, Consultant for Quality, Risk & Compliance, CSV


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