Quality by Design (QbD): Beyond Mere Compliance
Quality by Design (QbD) principles have been incorporated into regulatory guidelines for over two decades, so regulated life science companies are familiar with the requirements…
7 Ways to Reduce Chemistry Manufacturing Controls (CMC) Risk
Expedited Approval Pathways Increase Risk and Burden on CMC and Manufacturing: risk reduction strategies include earned value analysis and partnering. As discussed in a recent…
What Does Chemistry Manufacturing and Controls Mean?
At The Windshire Group, Chemistry Manufacturing and Controls (CMC) includes allied activities throughout the product lifecycle... While I believe the term, Chemistry, Manufacturing and Controls (CMC) …