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Old 16th February 2005, 11:11 AM
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Question Tracebility requirements in Pharma vs Medical Devices - Nonconformance issue
What are the tracebility requirements in Pharama Vs Medical Device?

I am investigating a Non-conformance situtation where I had missing units in a batch during processing? The integrity of the remaining units in the batch is fine. But there is no accountability for the missing units.

My question is that is tracebility is maintained for this situtation? Can I disposition the Catheters as "Use"?

Your Comments will be appreciated.

thanks

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Old 16th February 2005, 01:11 PM
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Is your device a combination product?
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Old 16th February 2005, 07:29 PM
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Default Tracebility Requirement
Its not a Combination Product. But I would also like to know if it is a combiantion product?

thanks

Deep
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Old 17th February 2005, 11:08 AM
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You haven't stated all the information. What is the extent of this issue? How many in the lot and how many are missing?

Pharma requires an investigation when yields are outside their expected range. Medical device regulations do not specifically require this, but you may want to issue a CAPA when this happens. Your CAPA procedure should address this.
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