The ISPE Guides – How Useful Are They?


Welcome back good people of the world! If you’ve been in “the industry” long, you’ve surely run across ISPE and maybe you’re even a member. I’ve been a member most of my career but don’t have any other strong affiliation, and feel like I talk about the group in an unbiased way.

ISPE publishes a lot of information. They have a bimonthly (every two months) magazine called Pharmaceutical Engineering which includes technical articles on everything Pharma, including commissioning/qualification/validation. These articles are typically  written by industry professionals and include case studies presented in a semi-academic format.

A question for you audience: if you’ve read these articles, how accessible do you find them? How often is one applicable to your day-to-day work?

The other major set of publications from ISPE are the so-called “Baseline Guides” and “Good Practice Guides.” These are typically around 200 pages and cost $150-200 to purchase. A list of guides available is here.

Which guides do you use? Can you describe an instance where the guides have helped you solve a real-world problem?

3 thoughts on “The ISPE Guides – How Useful Are They?”

  1. ISPE Guide “Applied Risk Management for Commissioning and Qualification” might be a place to start, but I honestly don’t know if you’re going to get your moneys worth. I would try freely available guidance from ICH, FDA, EMA, and various blogs/websites first. Hope this helps!

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