Discussion Forum

RE: KSM usage in process validation

Contribution from Nick written on 4/20/2012 at 07:15

Original contribution: KSM usage in process validation written by vasks on 4/18/2012 at 02:43)

It’s a nice topic. Let me express my view point on this. You know, if three different KSM suppliers are used to produce the API and proposed to regulatory authorities.
What they want to see that the quality equivalency of the API batches produced from all 3 sources. Hence, it would be wise to take 3 API batches using all 3 vendors KSM.
As by dong this you would be striking two aims with one stone. I.e. you could be able to prove the process consistency & reproducibility of your process as a core requirement of process validation. So,accomplishing your process validation requirements.
And simultaneously you could be able to prove all the 3 sources afford the API identical in all terms & respects of quality parameters.
I hope it helps. Any comments from Forum are welcomed.
Regards,
Nick

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