Friday, April 01, 2022 12:48:57 PM
After Northwest Bio applies for an MAA, the MHRA will still need to conduct another inspection of Sawston to insure that Advent’s Quality Management Systems are designed to meet the challenges, and comply with the principles of Good Manufacturing Practice for a commercial product.
It seemed to me that everyone was equating Flaskworks certification with commercial production readiness, which isn’t necessarily true, and why I wrote a post a while ago about the necessity of commercial process development. If the Flaskworks system is simply certified for use in investigational medicinal products, it would be an important validation for the system, but it would later require process validation for commercial production, which doesn’t make sense to me, unless commercialization is further away than I thought.
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