Qualification according to GMP ensures that technical equipment and systems work as desired and are suitable for their intended use. Often, this qualification is only to be done for companies at relatively high cost. However, there are ways to achieve significant efficiency gains in this area.
One key to substantial time and cost savings lies in Good Engineering Practice (GEP). This is because the test processes and associated records established there can, with prior, targeted coordination, be beneficially integrated into the qualification or used as a basis for setting up the qualification processes.
Ralf Gengenbach, Managing Director of gempex GmbH, will address this topic in his presentation "GEP – The Basis for Qualification" at the "Equipment Qualification Forum 2025," which the ECA Academy is offering as a live online seminar on November 18 and 19, 2025.
Key points of the presentation are:
- Basic engineering workflows (CD, BD, DD – EPCMQ projects)
- Process-, equipment engineers and more – the full picture
- Key documents in engineering processes
- FAT, SAT, and commissioning
- How a supplier can support qualification
- Typical pitfalls
This presentation represents an appeal based on many years of GMP practice in successful qualification projects: Good Engineering can form a basis for efficient qualification and GMP compliance.
Other topics on the event agenda include the ECA Good Practice Guide Qualification and Validation, inspector’s expectations in the validation life cycle, user requirement specification, AI and qualification, Pixi booklet, and lean validation case study.
The full program for the event, registration details, and further information are available on the organizer's website at qualificationvalidation.gmp-compliance.org.
If you have any questions about efficient qualification according to GMP, please contact Ralf Gengenbach at contact@gempex.com.
This might also interest you:
GMP Consultancy