gempex GmbH – THE GMP-EXPERT

Besselstraße 6
68219 Mannheim
Germany

LinkedIn
Contact WebSite

Founded in 2002 with a team of 15 experts, the company now has more than 70 employees worldwide who assist clients with the implementation, optimization, and maintenance of quality assurance systems.

Its client base includes leading companies in the chemical, pharmaceutical, biotechnology, cosmetics, and medical device industries, as well as their suppliers. The company’s services focus on consulting and project implementation in the areas of GMP compliance, commissioning and qualification, IT validation, and GMP routine. The range of services extends from initial analysis through the development and implementation of concepts to expert leasing.

Clients value gempex’s full-service offering and its proven expertise in the area of “Good Practices” (e.g., GMP, GSP, GDP) and comparable quality assurance systems.

Article

Topics • Strategy

Tomorrow’s Pharmaceutical Market?

There's been no trace of the original gold-digging market for a long time. The hyperbole and initial euphoria have been followed by disillusionment and stark reality.

Topics • Technology

Gempex supports European wholesalers in implementation of new GDP guidelines

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.

Topics • Technology

IT Validation – the Direct Way to Compliance

There is rarely a topic which polarizes experts more than the validation of IT-systems. Some would even comprehensively validate systems which only have a remote influence on product quality while others undervalue the meaning of obviously critical systems. A huge uncertainty can be observed everywhere as well as constant competition between too much and too little until the point of a complete and an escape to the good old world of paper.

Topics • Technology

China 3rd Party Audits – Last Call

Gempex and gemro respectively will be your partner when sourcing critical material from China.

Topics • Chemistry

7 Steps to GMP Compliance

Updating Chinese GMP Guidelines - The Chinese know that implementing good manufacturing practice (GMP) is a prerequisite for a certificate but in the past, the Chinese GMP system could not be compared to Western GMP standards.