If you are anywhere around the commissioning and qualification space, you know how important it is to any Pharmaceutical facility. There are so many resources out there to understanding how to approach these processes and on today’s episode of the Modern Biopharma Podcast I spoke with Jon Brown about his experience coming into a new facility and how he approached the substantial task of managing the commissioning of one of the largest Water For Injection (WFI) systems in the world.
Jon is a graduate of the University of Utah and currently works as a consultant in the RTP area serving manufacturers there. I really enjoyed getting to know Jon through our conversations
Questions we cover in the podcast:
Tell me a little about yourself and what you currently do.
2:05 - What is a book that you’ve recently read that you especially enjoyed? Algorithms to Live By (already started it and really enjoying it)
6:00 - Today we’re going to talk about commissioning and qualification of water systems…tell me more about why you enjoy working on water systems
8:00 What was your “task” and how did you approach CQ differently for this project?
15:00 - What do you care about in your quality system?
26:00 - How do we determine system boundaries?
36:30 - How important is it to both define those boundaries and DEFEND those boundaries from a quality perspective?
49:40 - What’s the number #1 thing you’d encourage a CQV team to do as they embark on a new system?
As some follow-up reading, here is a great article about Good Engineering Practices in Risk-Based Commissioning and Qualification by Chip Bennett.
ispe.org/pharm...