Since 2008, gempex GmbH has been represented in Switzerland with its own branch office, supporting manufacturers and suppliers in the implementation, optimization, and maintenance of quality assurance systems. The focus areas include compliance consulting, qualification, IT validation, and ongoing o…

gempex GmbH, the GMP service provider for the Life Science industry based in Mannheim, has been supporting manufacturers and suppliers since 2002 in the implementation, optimization, and maintenance of quality assurance systems. The focus areas include compliance consulting, qualification, IT valida…

Advanced Therapies are promised to be one of the main pillars in the future of personalized medicine. Manufacturing and clinical evaluation of pharmaceutical products in this field, so called “Advanced Therapy Medicinal Products” (ATMPs), have to meet regulatory requirements of “Good Manufactu…

The gempex GmbH, a GMP service provider from Mannheim, is supporting the ethanol manufacturer BrügmannAlcohol Heilbronn GmbH in obtaining a GMP certificate for ethanol. Ethanol in rectified or unrectified quality is used as an active and excipient in various manufacturing processes of pharmaceutica…

Maas & Peither, the publisher specializing in Good Manufacturing Practice (GMP), and gempex, the GMP expert in the life science industry, are collaborating. Both have pooled their expertise and years of experience in the GMP environment to develop a novel tool for conducting risk analyses.

The focus…

GMP risk analyses are a must. Every technically relevant system today is based on risk analyses. They serve primarily as a foundation for the individual qualification phases – whether for newly constructed systems or existing old installations. They help define the scope and depth of qualification…

During a workshop at the GIRP (European Association of Pharmaceutical Full-line Wholesalers) headquarters in Brussels, quality specialists from European wholesalers discussed the newly introduced regulatory GDP requirements with senior management of GMP consulting and execution company, gempex GmbH…

Qualification is an important instrument of quality assurance in the pharmaceutical industry, used to demonstrate the reliability of technical systems. Qualification involves significant effort, paperwork, time, and costs, and is therefore always a focus of efficiency discussions. For this reason, i…

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 intr…

After the elections in February of this year, the board of VIP3000 (Association of Pharmaceutical Construction Interest Group) convened for the first time in a new composition on April 5, 2013. The meeting took place at gempex GmbH in Mannheim, whose managing partner Ralf Gengenbach has held the cha…