Update of the schedule and work format under COVID-19 conditions

In the fight against the coronavirus (COVID-19) worldwide, we continue to offer our collaboration. Currently the need to provide quality medicines for human and veterinary use is especially noticeable. Our activity is focused on improving the level of the pharmaceutical quality system of manufacturers, which contributes to the promotion of safe and quality medicines on the market. The work of our experts continues in all areas.

Taking into account urgent requests from our partners and analysis of trends in non-conformities with GMP standards, identified during inspections of foreign manufacturers (https://gmpreg.com/en/analysis-trends), we continue to perform the remote service of documentation control of pharmaceutical companies for compliance with GMP standards. At the same time, large resources have been destinated for the preparation of the document package, including professional translation.

At the same time, the schedule of face-to-face audits is updated according to the preferences of the manufacturers.
In accordance with the client's request, the assessment is made based on the corresponding guides (EudraLex - Volume 4 - Guide to good manufacturing practices (GMP), The Order of the Ministry of Industry and Commerce of the Russian Federation of June 14 2013 "On Approval of Good Manufacturing Practice Standards" No. 916, Good Manufacturing Practices of the Eurasian Economic Union approved by Council Resolution of the Eurasian Economic Commission No. 77 of November 3, 2016 and others). At the same time, the trend related to the increase in requests for audits according to the Norms of the Eurasian Economic Commission (No. 77) is observed.

Due to the application of new scenarios for inspections by regulatory bodies (document control, controls with the use of audio and video media, etc.), we additionally offer consulting services to prepare for new inspection formats. At the same time we offer the organization of online support and consulting during the course of the inspection. The manufacturer's proactive approach during inspection can go a long way toward achieving a positive result.