E
Good morning all
We recently had an FDA inspection which resulted in a 483. One of the observations was:
Procedures for monitoring and control of process parameters for a validated process have not been established.
Specifically, no process validation procedures have been established.
As we always verified 100% of our product, we did not have an established procedure. We recently developed an in-house software system for use by our manufacturing staff. It was validated, but we didn't have a procedure in place before the validation describing the validation process.
Does anyone have a good process validation template I can use?
Thank you.
We recently had an FDA inspection which resulted in a 483. One of the observations was:
Procedures for monitoring and control of process parameters for a validated process have not been established.
Specifically, no process validation procedures have been established.
As we always verified 100% of our product, we did not have an established procedure. We recently developed an in-house software system for use by our manufacturing staff. It was validated, but we didn't have a procedure in place before the validation describing the validation process.
Does anyone have a good process validation template I can use?
Thank you.
