Bioequivalence and Bioavailability Forum

Hi Mittyri,

❝ 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!")

Also here.

“The situation with the inspection of foreign sites is diametrically opposite. In 2016-2017, 1167 applications were submitted to the Ministry of Industry and Trade, 589 inspections were carried out, 497 conclusions were issued. Almost 25% of manufactures were refused. The largest share of failures is accounted for manufactures located in Europe, »which, I emphasize, have been living for several decades in the regime of existence of regulatory requirements for production and inspection», Vladimir Shipkov commented.”

And some real examples from the head of Association of International Pharmaceutical Manufactures which represents the interests of foreign companies in Russia:
“The head of the AIPM cited examples of violations that were recorded by Russian inspectors: »Racks and floors are covered with a large layer of dust», »the fact of using chewing gum by a senior chemist is noted», »the laboratory has windows that are not identified as emergency exits.»” Looks funny, especially about gum .

However the representative from the Ministry answered:
“»Each time, assessing the degree of risk, we evaluate the entire set of comments. And when we see on the European site that by chance or negligence the manufacturer has made appropriate changes to the dossier for one country, and for Russia has not, and it means, the tablets are actually produced in India on an unknown site. When such situations arise, the question arises: how does the producer relate to the country where he delivers the drug? Does he have respect, responsibility? Probably not. This is expressed in the statistics that you give», – he said.”

Last paragraph is quite tough.

So, looks like the child is going to teach Daddy?