Rheinfelden, Schweiz, February 3, 2022:
The requirements for setting limits for cleaning validation have become more stringent with the entry into force of the revision of Annex 15 EU GMP Guideline in 2015. Since then, a substance-specific, scientific justification for the limit value calculation for active ingredient and cleaning agent residues has been required.
Authorities such as the FDA or national monitoring bodies also check the documentation for cleaning validation very intensively during inspections - as proof that product contamination can be ruled out within pharmaceutical production.
Even a few years after Annex 15 came into force, the topic is in high demand. The Swiss GMP and cleanroom seminar provider SCC (Swiss Cleanroom Concept) therefore organizes a seminar on "Cleaning Validation in the Field of GMP" every spring. For many years, GMP expert Jörg Koppenhöfer, senior consultant and cleaning validation specialist at gempex, has been supporting the event with expert contributions from the field:
Basics of cleaning validation
- Legal requirements / regulations
- Cleaning validation procedure
- Overview and preliminary work
- Risk analysis cleaning
When is a cleaning validation to be performed?
Inventory of equipment, products, processes
Bracketing & matrixing, selection of products, equipment, procedures - Documentation of cleaning validation
Cleaning validation plan (sampling procedures and methods)
Execution of cleaning validation
Cleaning validation report
Practical implementation in active ingredient production
- Legal requirements / regulations
- Statements
- Contaminants in active ingredient production
- Biological, Chemical
- Solids, solutions
- Materials
- Use of risk analysis
- Identify risks
- Goal
- Implementation
- Result
- Dealing with inventory data and data gaps
- Use of TTC value
- Calculation of PDE value
Further topics of the seminar are cleaning procedures, the PDE concept and cleaning validation from the point of view of the authorities, among others also presented by an inspector of the RHI.
Jörg Koppenhöfer will be happy to answer any further questions on this topic: info@gempex.com