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2017-05-04 11:20

Posting: # 17304
Views: 599

 Bilingual SOPs [GxP / QC / QA]

Dear All,

I have shifted to China to set up a Bio-Analytical unit for a Chinese Bio-equivalence organization. We are in the initial stages of building up a laboratory in China. I have some query regarding preparation of SOP and related forms to be used in regulated bio-analysis. We are planning to target studies for USFDA, EMEA, ANVISA, UK-MHRA, MCC and also CFDA.

Is it required to prepare every SOP bi-lingual i.e. in Chinese as well as English language? Can we prepare the SOP's in English language only. We are planning to recruit staff with English proficiency only from China, India or other countries. So will it be mandatory by CFDA that we prepare these SOP's in chinese also?

Also, regarding protocols and reports, can we submit English version of these to CFDA? or do they require the documents in Chinese language only?

Thanking you in advance.

Edit: Category changed; see also this post #1. [Helmut]

2017-05-08 16:20

@ varadpradhan
Posting: # 17319
Views: 288

 Bilingual SOPs

Hi varadpradhan

I'm not expert on Chinese regulation so please take the following with caution.

As far as I know, for CFDA you'll need documents (SOP, protocol etc) in Chinese. So even if all your staff are fluent in English, I'd suggest bilingual documentation system to avoid problem. Otherwise each time when you submit something to CFDA you'll have to do translation.

All the best,

2017-05-09 02:51

@ Shuanghe
Posting: # 17331
Views: 286

 Bilingual SOPs

Dear Shuanghe,

Thanks for your reply. Yes, we are thinking on the same grounds. We are planning to prepare all SOP's, Protocols in the English language and a translation copy of the same will be made available for CFDA.

I think, this would enable us to do submissions to any regulatory easier and reliable.

Thank you once again.
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