The perfect pharmaceutical project

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Every three years, the association Interest Group Pharmabau e.V., better known as VIP3000 e.V., offers a platform during a public event where prominent industry representatives meet with interested parties.

This meeting took place in April 2019 at the Gastwerk in Hamburg. The impressive venue alone was worth the journey. Built 120 years ago as a gasworks, today it combines modern design with historic architecture in the carefully restored industrial monument made of brick and glass, creating a fascinating harmonious presentation – the Gastwerk, Hamburg's first design hotel.

The client and planner always desire a project that, considering international GMP requirements including the application of modern aspects of integrated qualification and the use of the latest automation and IT tools, is executed professionally within the full time and cost framework.

That is actually impossible. To get closer to this goal, VIP3000 invited renowned representatives of the pharmaceutical industry to an expert dialogue in Hamburg on April 11 and 12, 2019. In a series of thematically diverse workshops, experiences with pharmaceutical projects in new builds and renovations were exchanged. Here, there was an opportunity to learn from case studies, hear what went wrong, and how to improve. Topics discussed ranged from contract design, planning tools, regulatory negotiations, to automation, qualification, and selecting the right personnel.

After registration and welcome, the first day of the event began with an introductory lecture by Hitoshi Takeda: "Good is better than perfect. The future in the era of speed and digital transformation." Mr. Takeda, responsible for Lean Management at Toyota, Japan, and also serving renowned clients in Europe, delivered his speech with perfect simultaneous translation into German.

In the afternoon of the first day, the workshop theme "The Perfect Pharmaceutical Project" was addressed in seven sessions.

All beginnings are difficult – setting up projects correctly.
According to the old wisdom that mistakes made at the beginning are hardly or no longer correctable later, the quality of a "perfect pharmaceutical project" must start with the right structure. Questions such as "What does an optimal project organization structure look like today?" and "What are the tasks and responsibilities of the investor before the feasibility study?" were discussed in group work led by Silvester Scholz (Takeda).

Perfection with modern Technology 4.0
Building Information Modeling (BIM) is the central buzzword for Industry 4.0 in construction management. BIM offers much more today than just 3D drawings. By leveraging data from nearly all components, today's networking enables unprecedented possibilities to select the right components early on. And this not only with regard to quality but also price. "How do modern systems influence project management in practice, and which ones make sense in terms of cost, time, and quality?" was one of the questions posed by Uwe Schwarzat (Boehringer Ingelheim) to the group.

When the Quality Unit Has a Say – GEP & GMP
Building in the pharmaceutical environment requires consideration of GEP and GMP requirements. Gert Moelgaard (Moelgaard Consulting) clarified questions such as "How far have the approaches of the American standard ASTM E2500 (focusing on GEP) already been implemented in the EU?" and "How to involve suppliers of equipment parts in the qualification process?"

The final word always belongs to procurement?
Increasingly, cost-efficient projects with consistently high-quality requirements are the focus. A key point here is procurement, which, due to economic considerations and necessities, has a significant say in the project process. The workshop led by Jochen Bucher (Merck KGaA) addressed questions around procurement: "What is the right procurement plan: package or individual awards?", "What if there is no planning for a partial award? How to determine the price?" and more.

Hurdles – Authorities are involved
In a globalized and now highly complex technical world, in addition to the demanding GMP regulations, various regional authority requirements must be observed. Thomas Elger (ELGES s.r.o.) worked with his group to answer questions like "Are requirements actually increasing, or are controls simply becoming stricter?", "How can such topics be bundled to avoid unnecessarily delaying construction processes?" and so on.

Smart Building Infrastructure – Possibilities and Limits
Modern management platforms for building infrastructure combine building automation and GxP monitoring in one system. "Does increasing automation always bring benefits?" This and other questions were addressed by the group around Thorsten Schmitt (Siemens). "Does the interaction of all trades necessarily lead to greater safety for the operator and their product?" "Do cross-trade and intuitive dashboard visualizations facilitate work in critical environments?" were additional topics.

The evening event at Rhainvilles Elbterrassen took place directly above the famous fish market and started with a sparkling wine reception and breathtaking views over Hamburg harbor. During the evening, information about the workshops was exchanged over excellent food, laughter was shared, and personal networks were expanded in a relaxed atmosphere. Around midnight, participants returned to the hotel.

The second day of the VIP3000 expert dialogue circle was different. Divided into workshops, half of the participants left the venue early in the morning for an extraordinary tour at European XFEL, where both a scientific and a technical part explained X-ray laser spectroscopy. It was later described as an impressive experience. The groups remaining at the hotel worked on consolidating the insights from the first workshop day and, upon the return of the first tour group, naturally also immersed themselves in the fascinating world of X-ray laser flashes from VIP3000 member XFEL.

After a joint lunch at the hotel, all workshop groups presented their previously processed results to the assembled participants, ensuring everyone gained the same level of knowledge after two days of intensive engagement with the topic. The second day of the expert dialogue concluded socially over coffee and cake, and with a participant certificate in hand, everyone headed home.