• Home
  • Blog
  • Have we really embraced the “new” Process Validation?

Have we really embraced the “new” Process Validation?

Since 1987 there has only been one major modification to the FDA’s Process Validation Guidelines, and that was in January 2011. Still viewed as a relatively “new” approach to Process Validation in the pharmaceutical, medical device, and biosimilar sectors, the fact is that these guidelines are nearing a decade old (!) and I’m not sure how well they’ve been embraced and implemented in our industry? So, what changed between 1987 and 2011? For most of us across the world we’ve seen a massive shift in how we consumed our entertainment and conducted our everyday living. VCRs, cassette tapes,...

Global Leader in Industrial Automation Solutions