Hallo together
We want to buy some semiautomatic machines for visual inspection of injections.
Is anybody there who can give me an idea how to validate this process?
And are there some regulations written down by FDA or something else?
Thank you
kind regards
Mattlin80
The visual inspection forum is there in PDA site.
You have to become a member there first.
You can download some documents .
You must also see Knapp test that was written in this forum.
Won’t find anything from FDA. It’s up to you to define requirements and validate to those requirements. Of course, the requirements have to be sound; i.e., if your requirements say it doesn’t have to find any defects, that’s not very robust.
The standard model for validation of such equipment would be IQ / OQ / PQ. This is not a prescribed organization but I find it thorough and is generally acceptable (if done correctly).
PDA ; PARENTERAL DRUG ASSOCIATION
There is a visual inspection forum. You need to have membership to log on and there are technical articles called Technical Report series TRS.
PDA Technical Report No. 43, Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing
Thank you for your answers! I will try to get a member by the PDA.
If anybody has other References please let me know!