BrüggemannAlcohol offers GMP-compliant ethanol production for its customers
As a manufacturer of high-purity ethanol, BrüggemannAlcohol Heilbronn GmbH offers its products to the food, pharmaceutical and medical product industries. More and more customers expect GMP-compliant production and quality assurance due to increasing regulation. That is why BrüggemannAlcohol Heilbronn GmbH decided to implement a comprehensive GMP upgrade with the goal of obtaining an official GMP certificate for the production of pharmaceutical active substances. gempex supported the ethanol producer’s project from the outset.
In addition to risk analyses for processes, automation and facilities, a detailed validation concept was introduced. New SOPs were prepared, existing ones were reviewed and revised as needed. Historical process and analysis data were also evaluated in the course of process validation. The qualification of rooms and systems was on the agenda along with extensive GMP training for Brüggemann’s employees. The preparation, realisation and follow-up for the one-day inspection by the Tübingen regional commission took place in close cooperation with gempex.
Rainer Krisam, consultant at gempex GmbH, is pleased: “Such projects are not only enjoyable but truly add value for our customers as well! Thanks to GMP certification, BrüggemannAlcohol Heilbronn GmbH is able to effectively guarantee production that meets the requirements of its customers and therefore the product safety they demand going forward.”