Page 31 - QA and QC

GMP Training – Quality Assurance and Quality Control by www.gmpsop.com

Why does GMP require us to validate processes?
One of the essential GMP requirements is to prevent cross-contamination of
products by using effective cleaning procedures and processes.

There are a few ways to check that products being processed in this tank are not
cross-contaminated:

1. Sample and test the tank after each cleaning.

The tank can be sampled and tested every time, but this is expensive, time-
consuming, and subject to sampling errors.

Additionally, there is a problem of what to test for: should the tank be tested
for detergent residues? Unremoved product? Bacterial contamination?

2. Test the finished product for contaminants.

This approach is not a reasonable or economic approach. Again, what
possible contaminants should be tested for? What will be the cost of rejecting
the batch if a contaminant is found? What would be the health risk to the
patient if the contaminant wasn't detected?
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