GMP certificate from Russia with love [GxP / QC / QA]

posted by mittyri – Russia, 2018-01-17 22:40 (2347 d 01:20 ago) – Posting: # 18197
Views: 6,089

Hi Helmut,

❝ Well, I don’t think that US manufactures which are regularly inspected by the FDA will tremble with fear when inspectors of the CDSCO wearing tin foil hats will enter their facilities.

Indeed some time ago a service was created in Russia for independent GMP inspection.
FDA? EMA? No, if you want to manufacture the substances/IMP for Russia, you need to get Russian GMP certificate (will be raised to EAUnion level soon)

Indian and European (HUGE European) manufacturers filed an application for GMP inspection immediately ("We spent thousands of hours with FDA/EMA inspectors, we can teach Russians to inspect in proper manner!")
You know what?
For non-speakers:
At 21th of July, 2016 Russian GMP certificates were given to 3 (THREE) foreign companies, 16 (SIXTEEN) companies are refused.
There are no public data regarding the reasons of refusal, only some roumors.
Some colleagues told me that the main reason is disrepancy between Russian and original documentation (was no up-to date).
Head of inspectors said:
The manufacturers are getting used to use desktop-oriented approach. 27% of findings are related to documentation.
There are some cases with no validation of processes.
There is a case with no (!) manufacturing line.
There are some cases with no data regarding abnormal toxicity tests performed but provided with submission.

Kind regards,

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