All posts by MikeWilliamson

Interested in collecting and analyzing data through software while travelling the world

Qualifying cGMP Warehouse Space

Warehouse

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.

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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?

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

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