Inspection activities aimed at confirming the compliance of a manufacturer of veterinary medicinal products with the requirements of Good Manufacturing Practice (GMP) are carried out by the Federal Service for Veterinary and Phytosanitary Surveillance (Rosselkhoznadzor).
An institution authorized to conduct inspections of manufacturers of veterinary medicinal products manufactured outside the Russian Federation (foreign manufacturers) is the Federal State Budgetary Institution “The All-Russian State Center for Quality and Standardization of Veterinary Drugs and Feed” (FSFI “VGNKI”)
In accordance with the inspection schedule published on the official website of the Rosselkhoznadzor 30.07.2019 , the largest number of applications for the issuance of the conclusion was submitted to the Rosselkhoznadzor for manufacturing sites located in Spain, France, and the USA.
REASONS FOR REFUSAL TO ISSUE A CONCLUSION
According to the register of issued conclusions published on the official website of the Rosselkhoznadzor 09.08.2019 , the reasons for refusing to issue a conclusion to foreign manufacturers were:
– non-compliance of the manufacturer with the GMP Rules requirements (32 refusals, which is 64% of the total number of refusals);
– the decision of the authorized body to refuse to conduct inspections (12 refusals, which is 24% of the total number of refusals);
– failure to eliminate violations when submitting an application and/or lack of confirmation of the fact of payment for issuing a conclusion (6 refusals, which is 12% of the total number of refusals).
RESULTS OF INITIAL INSPECTIONS
In the period from June 2017 to June 2019, employees of FSFI “VGNKI” conducted 56 initial inspections of manufacturing sites of foreign manufacturers:
- in 2017 – 18 inspections (11 refusals to issue a conclusion, which is 61% of the total number of inspections performed);
- in 2018 – 27 inspections (13 refusals to issue a conclusion, which is 48% of the total number of inspections performed);
- in the first half of 2019 – 11 inspections (7 refusals to issue a conclusion, which is 64% of the total number of inspections performed).
The average percentage of refusals following the results of initial inspections conducted from June 2017 to June 2019 was 55%.
An analysis of the results of initial inspections shows that manufacturing sites located in the USA and France received the refusals more often.
All 6 sites inspected in the USA were refused to issue a conclusion, and only one of the 9 sites inspected in France received a positive conclusion.
The average percentage of refusals following the results of initial inspections of the manufacturing sites of the largest foreign manufacturers and the sites of their contract manufacturers (CMO) amounts to more than 60% of the total number of inspections carried out at these sites.
In 2018, employees of the FSFI “VGNKI” performed 5 follow-up inspections of manufacturing sites of foreign manufacturers who were refused in 2017. Based on the results of these inspections, all sites were issued conclusions on compliance with the GMP Rules requirements.
In the first half of 2019, 2 follow-up inspections were performed. Based on the results of these inspections, a conclusion was issued to one site, and the other site received a refusal.
The average percentage of refusals following the results of inspections conducted from June 2017 to June 2019, taking into account the results of follow-up inspections, amounted to 51%.
PLANS FOR THE SECOND HALF OF 2019
In accordance with the inspection schedule, for the second half of 2019, more than 20 inspections of manufacturing sites of foreign manufacturers in Brazil, Germany, Spain, Italy, China, Romania, the USA, France, Switzerland, and Estonia are planned (including follow-up inspections).
On September 24, 2019, in Svetlogorsk city (Kaliningrad region), within the framework of the IV All-Russia GMP Conference with international participation, a panel discussion will be held on the topic “Issues of regulating the production and circulation of veterinary medicinal products“. It will be organized by the Federal State Budgetary Institution “The All-Russian State Center for Quality and Standardization of Veterinary Drugs and Feed” (FSFI “VGNKI”) subordinate to the Rosselkhoznadzor. GMP-conference is organized by The Ministry of Industry and Trade of Russia together with the Federal State Institution “The State Institute of Drugs and Good Practices” (FSI “SID & GP”). Registration is open on the official website of the Conference – http://gosgmp.ru/. .
The presented material was prepared using data analysis published on the official websites of the authorized body and the authorized institution. In the case of additional information, this data can be updated.
Konstantin Morozov, GMP Specialist of Ceva Sante Animale LLC