Pharmaceutical Industry Says No to Process Capability Oversight
This article was originally published in The Gold Sheet
Executive Summary
The pharmaceutical industry urges FDA to drop or modify process capability as a reportable metric in its draft quality metrics guidance and say that it does not provide a clear answer to whether a process is robust. FDA officials insist however, that with or without the metric, manufacturers need to do a better job of ensuring that their processes are in a state of control.
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