For over 20 years, Valicare has been providing validation services to the pharmaceutical, biotech, and medical device manufacturing industries. Valicare works with a GMP-compliant procedure based on Annex 15 of the EU GMP guidelines and the ECA handbook on integrated qualification and validation.

In addition to the routine application of the globally applicable GMP guidelines, including Annex 15 of the EU GMP Guideline, we apply the ECA Foundation’s good practice guide on Integrated Qualification and Validation on your request.

GMP validation must be risk-based to estimate the effects of deviations on process stability and product quality on the one hand, and t ...