Examples of Design and Process FMEA for Pharmaceutical Product Development

v9991

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#1
i have found couple of examples of design and process fmea for engineering; and i believe that it is mandatory part for devices as well...

can anyone pl. provide an example document for pharmaceutical product development and optimization/manufacturing.
 
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Chennaiite

Never-say-die
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#3
i have found couple of examples of design and process fmea for engineering; and i believe that it is mandatory part for devices as well...

can anyone pl. provide an example document for pharmaceutical product development and optimization/manufacturing.
V9991, could you tell us what you exactly mean by fmea for product development and optimization? Do you mean the product development 'process'?
 

v9991

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#4
yes' exactly,
risk associated with each individual product and its implementation of product/process development processesis my query....
 

pkost

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#5
I'm not sure if you are confusing terms.

Medical devices are required to have a risk management process. FMEA is a technique that can but is not required to be used to carry out the risk assessment

You then start talking about an example FMEA for pharmaceutical product development, which is different from medical devices
 

v9991

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#6
pl. help me ask right question or get right reference....
let me try
how to implement/adopt FMEA for process development and process optimization/manufacturing stages?

can we get examples of failure modes and causes for process development stage of pharmaceutical product
 

v9991

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#8
As it is some way outside my experience all I can suggest is something like this:-

http://www.amazon.co.uk/Pharmaceuti...+process+development+and+process+optimization
thank you for the reference, its a good reference; though, i checked out the book (on google books) ....FMEA ... its more from a operations/manufacturing point of view.
but anyways, thank you for the help.

here's another very usefull reference.....
Risk Management in the (Bio)Pharmaceutical and Device Industry

(but still not with specific FMEA examples for development and optimization of pharma)
 
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