Relevance of FMEA in Process Development [Pharma]

v9991

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#1
what is the relevance of FMEA in the process development activities.

especially in pharma, where all the processes are already aligned with respective regulatory/quality requirements; how can we justify the usage of FMEA during development process.

one thing which i can think of is that it captures all the process knowledge/learnings and is made available for all other processes. [viz., common failure modes] Ofcourse, FMEA shall aid in better objective-representation of the process development steps.
thanks in advance for your thoughts
 
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Bev D

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#2
the question may be better phrased as "why wouldn't you use FMEA in process development"?

while many processes are close replicates and there may exist a lot of a priori knowledge to leverage, there will alwasy be something new or different enough to warrant a look. (FMEAs dont' have to start from a blank sheet of paper). In fact the FDA recommends FMEA or a variant of it as a tool to develop appropriate Process Validation...
 
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