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
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