With the entry into force of the revision of Annex 15 EU GMP Guideline in 2015, the requirements for limit value determination for cleaning validation became more stringent. A substance-specific, scientific justification for the limit value calculation for active ingredients and cleaning agent residues is required.
In addition, authorities such as the FDA or national monitoring bodies also check the documentation for cleaning validation very intensively in their inspections. After all, this proves that product contamination can be excluded in pharmaceutical manufacturing.
Every year, SCC (Swiss Cleanroom Concept) presents a training course on "Cleaning Validation in the field of GMP". Also this year on 03 March 2021. Accordingly, the topic is in high demand even more than five years after the entry into force of the Annex 15 revision.
GMP expert Jörg Koppenhöfer, Senior Consultant and cleaning validation specialist at gempex, will support the event with expert lectures from the field:
Basics of Cleaning Validation
- Legal requirements
- When is cleaning validation needed?
- Bracketing and matrixing
- Sampling (swab, rinse, microbiology)
Practical Implementation in API Production
- Contamination in API production
- Use of risk analyses
- Dealing with inventory data and data gaps
Further topics of the technical seminar are cleaning procedures, the PDE concept and cleaning validation from the authority's point of view. Speakers here are, among others, the “GMP-Verlag Peither AG” and an inspector from the “Regionales Heilmittelinspektorats der Nordwestschweiz” (RHI).
For further questions on this topic, please contact Jörg Koppenhöfer at info@gempex.com.