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English requirement for FDA regulated records?

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Bartholamew

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Posted 13 May 2022 - 06:29 PM

During a recent conversation with an experienced (albeit retired) process authority, he mentioned a requirement that process records for LACF must be documented and available to investigators in English. I've searched all relevant sections of the CFR that I can think of without success; the closest I found was guidance from FDA indicating that English documents may not be available in international facilities, but that copies not in English shall be collected for review by CFSAN.

 

To me, this implies that English documents would be available for FDA regulated plants within the US and therefore an expectation. Is this the case? Where can I find more information?


Edited by Bartholamew, 13 May 2022 - 06:29 PM.


Spidey

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Posted 13 May 2022 - 08:33 PM

When I went through my FSVP training, they talked about the language of records.  As long as you have an employee who can translate or have the ability to hire a translator, it is acceptable to keep records in a language other than English.  See pages 233 and 235 of the attached manual.

 

I don't know how this relates to domestic FDA documentation.

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Charles.C

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Posted 14 May 2022 - 06:27 AM

During a recent conversation with an experienced (albeit retired) process authority, he mentioned a requirement that process records for LACF must be documented and available to investigators in English. I've searched all relevant sections of the CFR that I can think of without success; the closest I found was guidance from FDA indicating that English documents may not be available in international facilities, but that copies not in English shall be collected for review by CFSAN.

 

To me, this implies that English documents would be available for FDA regulated plants within the US and therefore an expectation. Is this the case? Where can I find more information?

Re ^^^blue -

from guidance -

There must be some form of documentation on hand at the factory; at least a letter or other similar transmittal from the processing authority, which details all factors critical to the delivery of the scheduled process.

 

Must is not an imperative but seems definitive.

 

Documents perhaps not necessarily available to the public and possibly not in English if the actual language was directly understandable to relevant review personnel.

 

Logically ask FDA if more info. required.


Kind Regards,

 

Charles.C






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