GMP Knowledge for Plant Manufacturers and Suppliers

The gempex GmbH, headquartered in Mannheim with a branch in Sisseln, Switzerland, specializes in the implementation of GMP. For over 10 years, they have supported not only pharmaceutical manufacturers but also equipment and machinery builders as well as suppliers in the GMP environment with the introduction, optimization, and maintenance of quality assurance systems. What makes gempex unique is the combination of services offered. Depending on the need, gempex provides consulting (Compliance Consulting), comprehensive project management (Project Execution), or staffing solutions for peak personnel requirements (Expert Leasing) – tailored individually and according to requirements.

The extensive expertise of many employees, gained through years of experience in the GMP environment, is willingly and gladly shared; and not only with the pharmaceutical industry. For example, in April, they organized a GMP info day together with VDMA Food Machinery and Packaging Machinery on the topic “Machine Documentation in the Pharmaceutical Environment,” where they were able to bring the participants – all from the supplier sector – closer to the topic of GMP and the essential requirements for suppliers from the customer’s perspective, thus highlighting common misunderstandings and cost pitfalls.

But gempex is not only familiar with work at the interface with suppliers. At the 15th VDI Conference on Cleanroom Technology (from the VDI Knowledge Forum, June 12–13, 2013), the managing director of gempex GmbH, Mr. Ralf Gengenbach, will share his expert knowledge and provide insights into possible future developments on the technical side. In his presentation “Trends in Facility Qualification – New Approaches in the Pharmaceutical Industry,” he will examine the development of qualification, which is indispensable for quality assurance but always involves significant effort, paperwork, time, and costs, and is therefore often a focus of efficiency discussions. The presentation will highlight, among other things, the importance of manufacturers of technical systems, which is gaining weight for a possible concept of modern qualification to reduce future efforts to what is necessary without risking quality losses.