With gempex to GMP certification

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 pharmaceutical preparations. Therefore, Brügmann's customers demand GMP-compliant manufacturing and quality assurance to ensure product safety.

The start of the GMP upgrade was in May 2014, with the goal of holding the GMP certificate by autumn 2015. "This is a great challenge for all involved," said project manager Michael Luippold from gempex. For this purpose, a GMP target-actual analysis was conducted to determine the needs and derive specific measures. A series of different activities are planned: GMP training, qualification and validation tasks, and the adjustment of the existing quality management system to include GMP-relevant topics.

If speed and quality are maintained during implementation, all measures will be completed in 2015. Afterwards, Brügmann can face an inspection by the authorities and – provided a successful audit – obtain the GMP certificate for ethanol.