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.