- Seminar on February 02, 2023 in Rheinfelden, Switzerland
- GMP expertise from gempex for practice
- Basics, PDE concept, authority view, practice
The revision of Annex 15 to the EU GMP Guideline brought fundamental changes to the requirements for setting limits for cleaning validation. A scientific, substance-specific justification in the limit value calculation for active ingredient and cleaning agent residues is required. The toxicological criterion PDE as well as the validation of service lives are required, for example.
The aim is to provide evidence that contamination of the product is excluded in the respective pharmaceutical production. This is the focus of an increasing number of inspections by the authorities.
The seminar "Cleaning Validation in the GMP Environment" of SCC Swiss Cleanroom Concept on February 02, 2023 in Rheinfelden provides clear basic knowledge about cleaning procedures, fundamentals and acceptance criteria and trains the implementation in GMP-regulated production. The PDE criterion "Permitted Daily Exposure" will be presented.
gempex brings GMP expert knowledge from practice to the seminar. Jörg Koppenhöfer, Senior Consultant gempex GmbH, has been supporting companies in the pharmaceutical and chemical industries with GMP compliance topics for many years. In the seminar, he will speak on the following topics:
Basics of cleaning validation
- Legal requirements
- When is cleaning validation needed?
- Bracketing and matrixing sampling (swab, rinse, microbiology)
Practical implementation in active ingredient production
- Contamination in active ingredient production
- Use of risk analysis
- Handling inventory data and data gaps
Further contents of the technical seminar are sampling procedures, risk analysis, milestones, analytics in cleaning validation and the view of the authority.
The detailed program and the registration form are available on the website of the organizer SCC Swiss Cleanroom Concept.
For questions on the subject of cleaning validation, please contact Jörg Koppenhöfer via contact@gempex.com.