How does the customer benefit?
In difficult and complex situations practicable concepts for cleaning validation are developed and implemented despite time pressure, so they later can be audited by FDA, EMA or other authorities successfully.
Case 1:
A leading global pharmaceutical company decided to validate all cleaning processes for their biggest API site world-wide. Our team developed the concept, the master plan and the templates for the plans and reports. we developed the matrices for risk assessment of the equipment, products and change-overs (approx. 10’000 data points), which significantly simplified the task. The concept has been reviewed and accepted by the FDA. Because it was very practical, lean and FDA compliant, the company decided to roll out the concept worldwide. M. Vavrecka was the co-author of the global guideline.
Case 2:
A mid-sized global pharmaceutical FDF company had to improve their cleaning validation concept based on findings of the local authority in an audit. For the follow-up audit MVLSC helped the company to prepare the matrix for the calculation of the residue contamination for all possible production equipment chains, developed the concept for the worst case products, a risk assessment of PDE versus daily dose based acceptance limits and the matrix for the risk assessment of all possible cross-overs. The follow up audit was very successful.
