Cleaning procedures must be validated on a risk-based approach
Valicare offers a basic training to step in the cleaning validation. In addition, we advise and support our customers in implementing validation.
In pharmaceutical production and especially in multipurpose facilities cleaning processes have to be validated. The new european guideline introduced by the European Medical Agency in 2015 switched limit requirements from chemical to toxicological values, the so-called permitted daily exposure or PDE-values.
The maximal daily exposure of a patient was set as binding standard for the evaluation of cross contaminations in pharmaceutical products.
The leading document for execution of cleaning validation in Europe is the annex 15 of the EU GMP guideline, describing a risk-based approach for any definition of validation measures.
Valicare GmbH offers intensive educational training on the basics of cleaning validation. In addition we offer to our customer topic related consultancy and documentation work irrespectively to that whether cleaning validation execution is planned in line with new toxicological evaluation or standard chemical criteria basically used during former years.
A key competence of Valicare GmbH is the application of product and equipment bracketing. Development and installation of GMP- compliant cleaning processes and cleaning validation for manufacturing of medical devices complete the scope of services in this area.