The manufacturing of pharmaceutical active ingredients and medicines takes place in a strongly regulated environment. For reasons of patient safety, impurities and cross-contaminations as part of the production process must be able to be ruled out. The authorities place great value on effective and validated cleaning processes for the removal of unwanted materials and coverings from surfaces and production items.
The legal regulations can be found for example in the PIC/S-Guidelines, the EG-GMP guidelines on Good Manufacturing Practice or in the Guide to Validation of Cleaning Processes from the FDA.
Are you looking for an analysis partner for cleaning validation? Do you require advice in the interpretation of legal requirements or do you need support in planning the analysis of your cleaning validation?
As a GMP-certified and FDA-approved test laboratory in Switzerland with many years of experience, we can provide you with support in method development, validation and routine testing of the analyses as part of your cleaning validation. We will test for you in accordance with legal guidelines or to your own specifications. Take advantage of our experience. We will be happy to advise you.
Read on here for more information or contact us.