You need to understand your process, define what the acceptance criteria is, and then challenge the process. The idea is once you have a validated process, you don’t have to look at the acceptance criterion each time, just monitor that the process is under control.
Monitor process while performed under controlled conditions
Define successful results beforehand
Challenge the process
Determine efficient ways to monitor the successful process
Document the process testing
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.
Continue reading Qualifying cGMP Warehouse Space
So what do you do? I hope you already have a SOP to handle these. If not, let me get you started!
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. Continue reading The ISPE Guides – How Useful Are They?