T
todayssunny
Hi All,
Imagine I have a devation in the manufacturing process in place.
The deviation was requested and approved before the work order was started. a) It is applicable for a defined period of time only.
or
b) ... applicable for a certain number of lots/batches.
How is FDA expecting me to link such a deviation to the DMR?
Some consultants adviced us to get rid of the deviation process as for the time of the deviation in place, we do not manufacture according to the approved DMR.
Any reply is highly appreciated...
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just for clarification... by DMR I mean Device Master Record (Medical Devices) --> sorry for any confusion caused
Imagine I have a devation in the manufacturing process in place.
The deviation was requested and approved before the work order was started. a) It is applicable for a defined period of time only.
or
b) ... applicable for a certain number of lots/batches.
How is FDA expecting me to link such a deviation to the DMR?
Some consultants adviced us to get rid of the deviation process as for the time of the deviation in place, we do not manufacture according to the approved DMR.
Any reply is highly appreciated...
---------------------------------
just for clarification... by DMR I mean Device Master Record (Medical Devices) --> sorry for any confusion caused
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