How does the customer benefit?
In difficult and complex situations practicable concepts for process validation are developed and implemented despite time pressure, so they later can be audited by FDA successfully.
Case 1:
A leading global pharmaceutical company decided to validate all API processes of their major production site (65% of the world wide output then). We developed a feasible concept, produced the master plan and templates for all documents, built up 3 labs with 14 FTE and validated 80 chemical steps within 2 years. Prior to this improvement the company was able to validate only 2 processes within several years. The project was very successful and the company decided to roll out the concept into the whole corporation per a global guideline. We co-authored this guideline.
Case 2:
As consequence of FDA pressure, a leading global pharmaceutical company had to re-validate all FDF processes (approx. 600) of one of their major production sites. A feasible concept had to be developed within a very short time frame before a FDA follow up audit. MVLSC developed the concept in the required time. The FDA audit was a success. Then, MVLSC designed a validation group, and helped to build (20 FTE), train and start it. The validation group continued successfully and autonomously their work after MVLSC left.
