gempex GmbH, the GMP service provider from Mannheim assists the ethanol producer BrüggemannAlcohol Heilbronn GmbH in obtaining a GMP certificate for ethanol. Ethanol in denatured or undenatured quality is used in various production processes of pharmaceutical preparations as active ingredient and excipient. BrüggemannAlcohol customers therefore demand GMP-compliant production and quality assurance to ensure product safety.
The GMP upgrade kicked off in May 2014 with the objective to obtain the GMP certificate in autumn 2015. “This is a big challenge for everyone involved,” said project manager Michael Luippold of gempex. Using a GMP target-actual analysis the demand was determined and specific measures were derived from it. A whole range of activities are planned, such as GMP training, qualification and validation tasks and the adaptation of the existing QM system to incorporate GMP-relevant topics.
If the pace and quality are maintained in the implementation, all measures will be completed in 2015. When all is completed, BrüggemannAlcohol can be inspected by the authorities and – assuming a successful audit – obtain the GMP certificate for ethanol.