The Life Sciences team knows the right prescription for cost-efficient pharmaceutical buildings. The active ingredients include 3C Management, internationality, and lots of experience.
Sensitive buildings as in the Life Sciences indusries require experts with broad experience and a knack for handling specific requirements. The eight-member team led by Rino Woyczyk knows the panacea for pharmaceutical, medical technology and medical biotechnology facilities. For over ten years, the engineers and architects have been handling production facilities, distribution centers, laboratories and office buildings for the life sciences industry at home and abroad. “ The companies face a double hurdle,” says Rino Woyczyk.“ They not only have their own demanding standards for buildings and systems, but must also satisfy the stringent requirements of the licensing authority in a particular country or continent. This authority checks that the design and execution of the buildings, plant and equipment – and the manufacturing processes for which they are used – comply with the rules of Good Manufacturing Practice (GMP).”
Super fast track processes
In addition to quality demands, the time required for construction is also critical. Nowadays, pharmaceutical projects are completed using the super fast track process, so that the time to market for the product being manufactured is kept as short as possible. And it is precisely here that the Dreso pharma industry experts excel. Together with the GMP consultants Gempex, Drees & Sommer has developed a process for integrated management of Construction, Comissioning and Compliance – called 3C Management for short.
This process describes the interdisciplinary execution of construction projects in the pharmaceutical, biotechnology and medical technology industries. The three Cs stand for the three phases: Construction (planning, execution), Commissioning (of plant and equipment and production lines), and Compliance (GMP compliance). These phases are interdependent and must be considered as one. “For this reason both building design and process planning and qualification measures need to be closely coordinated as early as the project initiation phase. To achieve this, we draw up a detailed schedule in a very early phase of the project. This shows an overview of the individual phases,” explains Ulrich Kaufmann.
When in Rome, do as the Romans
The pharma industry is undergoing huge change. Amongst other things, this is resulting in an increasingly global focus. New plants are needed both at home and abroad to develop new international distribution channels. Countries that were not previously a priority are becoming important markets. But as the saying goes: When in Rome, do as the Romans. “When you go to a different country, you have to be familiar with the general conditions there – climatic, legal, organizational, economic and political,” says Axel Heueis. This means that in addition to project-specific features, country-specific aspects have to be incorporated into an overarching, integrated schedule and cost structure. For this reason, the Drees & Sommer Life Sciences team often travels far and wide, supporting projects in a range of regions and countries including South America, Indonesia and Russia.