How to handle Nononformances in Clincal Manufacturing ?

1

123pr

Ok, here is my first Elsmar post ever!!!
We are starting the first clinical trial at a commercial manufacturing facility.Does anyone know if we will be required to use our existing Nonconformance system to track “deviations” during our clinical production run?We are only doing one run, and are performing it as a protocol….very similar to a Validation Protocol.Any input is appreciated.Thank you!!!
 
1

123pr

Since it is done under a protocol...I was thinking we won't have them defined as NCs. They would merely be discrepancies to the protocol/ Thoughts/suggestions?
Appreciate the response!
 
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