During inspections, authorities such as the FDA or national regulatory authorities also closely examine the documentation of cleaning validation as proof that product contamination can be ruled out in pharmaceutical production. The revised Annex 1 also explicitly requires this proof and demands clear documentation.
The revision of Annex 15 to the EU GMP guidelines brought fundamental changes to the requirements for cleaning validation and the setting of limit values. The calculation of limit values for active ingredients and cleaning agent residues is required as a scientific, substance-specific justification. The toxicological criterion PDE and the validation of down times are also required.
The aim of the seminar "Cleaning Validation in the GMP Environment," offered by SCC Swiss Cleanroom Concept on November 5, 2025, in Rheinfelden, Switzerland, is to provide solid basic knowledge about cleaning procedures, fundamentals, and acceptance criteria. Training will be provided on implementation in GMP-regulated production, and the PDE criterion "Permitted Daily Exposure" will be presented.
gempex supports the event with practical GMP expertise. Jörg Koppenhöfer, Senior Consultant at gempex GmbH, has been active for many years in GMP compliance issues for companies in the pharmaceutical and chemical industries.
In the seminar, he will speak on the following topics:
Basics of cleaning validation
- Regulatory requirements
- When is cleaning validation required?
- Bracketing and matrixing Sampling (swab, rinse, microbiology)
Practical implementation in active ingredient production
- Contamination in active ingredient production
- Use of risk analyses
- Dealing with inventory data and data gaps
Sampling procedures, risk analysis, milestones, analytics in cleaning validation, and the perspective of the authorities are further topics covered in the specialist seminar.
The detailed program and registration form are available on the website of the organizer, SCC Swiss Cleanroom Concept.
For any questions on the subject of cleaning validation, please contact Jörg Koppenhöfer via contact@gempex.com .
This might also interest you:
Detailed technical articles on the topic of cleaning validation are available at gempex.de/GMP-Wissen:
Reinigungsvalidierung (German language)
Regularien und Guidelines / Toxikologie-Akzeptanzkriterien / Beispiele aus der Praxis
Raimund Brett, gempex GmbH
Published in: pharmind 12/2021
Reinigungsvalidierung in der Wirkstoffherstellung (German language)
Prinzipien, Risikoanalyse/ Risikobetrachtung, regulatorische Anforderungen und Akzeptanzkriterium PDE-Wert
Jörg Koppenhöfer, gempex GmbH
Published in: pharmind 06/2019