3-C-Management by Drees & Sommer and gempex guides builders safely through the construction process

3-C-Management

Ralf Gengenbach

Rino Woyczyk

Construction processes in the Life Sciences industry are comprehensive and not easy to implement. They require careful planning, especially in the preliminary phase, to ensure all necessary steps are included that guarantee a smooth construction process, as well as later technical and qualification procedures: not only must common building regulations be adhered to, but also the industry-specific rules and standards – primarily GMP – must be met. With the 3-C Management from Drees & Sommer and gempex, project owners are on the safe side.

It's an old problem: when a company in the life sciences sector wants to realize a new building, for example for its production technology, they have to think on different scales that have little to do with their daily business. After all, the goal is to realize a building within an economically acceptable timeframe and budget that is functional and simultaneously meets all the requirements of the life sciences industry. This means deadlines must be met, regulations considered, various trades coordinated and harmonized, and ultimately, a final conformity certificate (GMP certificate) must be obtained from the relevant authorities. This requires not only meticulous, detailed planning but also early involvement and leadership of all process participants to ensure a smooth and seamless process.

However, in reality, the construction project, process technology, and qualification are often planned separately, with schedules and necessary actions not carefully coordinated. Additionally, the different trades (construction – process – GMP) often work independently without sufficient coordination or being led by a central contact person. Thus, the architect primarily focuses on the aesthetics and functionality of the spaces, the engineers on the process technology to be installed, and the GMP expert on their guidelines. This leads to errors, delays, and possibly even jeopardizes inspections at the end. Just a one-month construction delay and the resulting production downtime can cause costs in the millions.

Two specialists join forces

To avoid this, expertise and many years of experience are required. Drees & Sommer and gempex bring both: Drees & Sommer has been supporting private and public clients and investors for over 40 years with all questions related to real estate. The partner-led company, headquartered in Stuttgart with a total of 34 locations worldwide, sees itself as an international service provider for development consulting, infrastructure consulting, project management, real estate consulting, and engineering. The focus is on economic efficiency, but sustainable building is also promoted as much as possible.

gempex, on the other hand, is an expert in quality assurance. The company, based in Karlsruhe with additional locations worldwide, is continuously expanding. A large number of engineers and natural scientists from various disciplines with extensive experience in GMP topics are involved, offering services ranging from consulting to implementation, from one-time contacts to multi-year large projects and ongoing support, from creating work instructions to qualifying entire production facilities, and from initial consulting to support during inspections. Together, both companies form an unbeatable team for the benefit of their clients.

The 3-C Management from Drees & Sommer and gempex ensures project success for clients

Rino Woyczyk, Managing Director of Drees & Sommer, and Ralf Gengenbach, Managing Director of gempex GmbH, met and appreciated each other through the pharmaceutical association VIP 3000 e.V. “The problem of separating the individual areas is well known in the industry,” says Gengenbach. “But so far, people have just accepted it.” However, the two entrepreneurs, who repeatedly encountered similar situations in their consulting roles with companies, did not want to accept this unsatisfactory situation: “The industry must and can improve further,” says Woyczyk. “Companies are under strong external pressure, and competition is increasing.” Speed, precision, and expertise are equally demanded. Failures such as delays in construction can no longer be afforded by any company today. “That’s why we wanted to find a solution to this fundamental problem in the industry to optimize the execution of construction projects and implement them according to GMP guidelines,” adds Gengenbach. The result is the 3-C Management.

The 3-C Management from Drees & Sommer and gempex takes a holistic approach. It is based on three components: Construction (design and building), Commissioning (start-up and qualification), and Compliance (GMP implementation and inspection). This means that thanks to the 3-C Management, all details and even the smallest steps across all areas of project management—from planning through awarding contracts to completion of construction and qualification of spaces and their equipment—are recorded and carefully coordinated. Drees & Sommer acts as the project controller, moderating the construction process, coordinating trades and individual construction phases, and communicating among the involved parties. The external perspective guarantees an objective view, and the independence of the partners remains intact. The 3-C Management ensures increased efficiency and transparency for all involved parties, and provides the client with a smooth, timely completion of the construction and process project within the budget framework.