Design Pharmaceutical Qualification Processes Efficiently

Know How!
The question of whether pharmacists implement GMP compliant qualification of production facilities or the validation of associated processes no longer arises today. Today, the question is how the effort can be kept as efficient (low) as possible in order to ensure GMP compliant product quality, whilst maintaining productivity at the same time. 

In an interview with PQX Pharma Quality Exchange, Ralf Gengenbach, Managing Director of gempex GmbH, explains where there is room for optimization in qualification.

Further topics are difficulties in understanding the implementation oft he qualification, qualification of equipment oft he suppliers, scope of qualoification, interpretation of the specifications, importance of Good Engineering Practice, risk analysis as central tool, cooperation of supplier and pharmaceutical manufacturer, lean qualification concepts.

The interview is available for download at and was published on the PharmaQualityExchange platform.

Ralf Gengenbach is available for questions and to exchange ideas on the topic. Please address via