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 pharmaceutical 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.

https://ispe.org/pharmaceutical-engineering/may-june-2020/good-engineering-practice-risk-based-commissioning