Which documents should be in English for the FDA

[Dudes]

Our internal documentation as well as our whole Quality Management System are written solely in the local language. Does the FDA have any regulation (or guidelines) on what should be available in English?

I'm not talking about the documentation submitted to get a 510(k), but about all the internal docs that they could look at during an audit...

 

[Ajit Basrur]

Our internal documentation as well as our whole Quality Management System are written solely in the local language. Does the FDA have any regulation (or guidelines) on what should be available in English?

I'm not talking about the documentation submitted to get a 510(k), but about all the internal docs that they could look at during an audit...

Great question

We had discussed this earlier in Do Quality System Documents have to be in English (for USFDA onsite inspection)

Usually Organizations in non English speaking countries have the Level 1 (Quality Manual) and Level 2 (Procedures) made bilingual - local language + English to benefit both the employees and second / third parties.

From FDA perspective, there is one reference for English documents at SUBCHAPTER 1.1 - ENGLISH LANGUAGE REQUIREMENT FOR FDA DOCUMENTS

 

[Dudes]

Great question

Usually Organizations in non English speaking countries have the Level 1 (Quality Manual) and Level 2 (Procedures) made bilingual - local language + English to benefit both the employees and second / third parties.

From FDA perspective, there is one reference for English documents at SUBCHAPTER 1.1 - ENGLISH LANGUAGE REQUIREMENT FOR FDA DOCUMENTS

Thank you! Apparently, there is no requirement have the documents bilingual.

The link provided for FDA perspective applies to the documents made by the FDA (as far as I understood it at least). My concern is that all our internal documents (starting with the quality manual) are in the local language. And I wouldn't want to have a problem if and when they come to inspect...

 

[Ajit Basrur]

Thank you! Apparently, there is no requirement have the documents bilingual.

The link provided for FDA perspective applies to the documents made by the FDA (as far as I understood it at least). My concern is that all our internal documents (starting with the quality manual) are in the local language. And I wouldn't want to have a problem if and when they come to inspect...

You are right - there is no requirement for documents to be bilingual but as I mentioned earlier, most organizations opt this so that the auditors / inspectors could find it easy.

 

[Pads38]

The link provided for FDA perspective applies to the documents made by the FDA (as far as I understood it at least). My concern is that all our internal documents (starting with the quality manual) are in the local language. And I wouldn't want to have a problem if and when they come to inspect...

You don't say which country you are in. In the UK many of the FDA inspections are actually performed by BSi staff, under contract to FDA. Do you have a similar situation where you are? If so local language shouldn't be any problem.

 

[MIREGMGR]

I believe in those countries where inspections are performed by contractors, the contractors essentially follow the rules established for the AP ("Authorized Party") program.

The AP guidance says:

FDA expects the APs' reports and any clarifying information requested by FDA to be provided in English. Any documents collected from the manufacturer may be in the operational or working language used in the manufacturer’s facility. However, the time necessary to translate the firm’s documents may delay FDA’s endorsement.

My understanding is that when the FDA conducts other-country inspections itself, it uses a similar procedure, i.e. the inspector prepares a report with analysis and recommendations, and sends that report to Washington where it is reviewed in detail and a determination made. If the supporting information for that report is not in English, I believe the translation work in done in the Washington office, where the foreign manufacturer has no control over translation accuracy.

My view would be that a manufacturer that for some reason needs especially quick FDA responses would be well served to make sure that everything the FDA needs is already in English and well translated; but, this is voluntary.

 

[Ronen E]

You are right - there is no requirement for documents to be bilingual but as I mentioned earlier, most organizations opt this so that the auditors / inspectors could find it easy.

I understand the benefits but there would also be a double burden - every time a document is revised. Plus, sometimes there are subtleties that are not conveyed very well through translation, and worse, if translation is not very careful even new and unintended meanings could be introduced - which would bring up the question: which version rules?

 

[treesei]

I understand the benefits but there would also be a double burden - every time a document is revised. Plus, sometimes there are subtleties that are not conveyed very well through translation, and worse, if translation is not very careful even new and unintended meanings could be introduced - which would bring up the question: which version rules?

There is always such risk in any translation. When inconsistency occurs, the original language version rules.

 

[Ronen E]

There is always such risk in any translation. When inconsistency occurs, the original language version rules.

As a rule that makes sense, however, that would require a bilingual auditor by default - otherwise how would you convince the auditor that a deviation is due to inconsistency in translation?

 

[treesei]

As a rule that makes sense, however, that would require a bilingual auditor by default - otherwise how would you convince the auditor that a deviation is due to inconsistency in translation?

A bilingual auditor could be a two-fold sword.

To a non-bilingual auditor, if s/he knows anything about translation s/he will understand that no translation can deliver all subtle measings in a language. What I would do: 1) Do a good job in translation. a document full of grammar/spell mistakes will lead to questions about its content accuracy. 2) Tell him/her with confidence that your translation is good. The use of professional translation services may add value (with cost). 3) If inconsistency is found during the audit, convince him/her that what you actually follow is the ruling original document, not the wrong translation. And thank him/her for finding the mistake.

A competent auditor will not believe that a translation is absolutely accurate but will understand the situation unless the audit is going down to a horrible direction.