Qualifying cGMP Warehouse Space

Hello, good people of the world! So you have a cGMP warehouse you need to qualify? Well, this post will provide plenty of information to get you started.

First, how do you know your warehouse is a “cGMP” warehouse. Well, it is if:

• The warehouse will house any raw material, excipient, intermediate, or finished product
• The warehouse will house equipment or process consumables, such as filters, bags, disposable tubing, etc.
• Any cGMP operations will occur in the warehouse, such as sampling, dispensing, kitting, track and trace, etc.

Any examples of common or even possible non-cGMP warehouse space in the Biopharma industry? Please leave a comment below.

Deviations, Discrepancies, Variances, Exceptions – You Know You’re Gonna Have ‘Em

So what do you do? I hope you already have a SOP to handle these. If not, let me get you started!

HOT NEW TREND: Risk-Based Validation

Risk Management Options

IQ, OQ, PQ – Where Did These Terms Come From?

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.

Welcome to Mike Williamson Validation

Welcome good people of the world! Whether you’re an Engineer at a pharmaceutical company, a Quality representative in Biotech, or just someone interested in learning a bit more, you are making the world a better place.

Commissioning, Qualification, Verification, Validation – what does it all mean?

This blog contains FREE INFORMATION – always and forever.

I have over 10 years of validation experience, and am here to share what I’ve learned and to learn from you – please comment!

What topics would you like to see posted?