Joint GMP inspection training
On 18-20 June a joint pharmaceutical inspection of the Eurasian Economic Union inspectorates, organized within the Working Group on formulating common approaches in regulation of drugs circulation within the Eurasian Economic Union and the Working group, which is currently being established, on issues related to pharmaceutical inspections’ conformity with the rules of Good Practices in the field of drugs circulation within the Eurasian Economic Union under the Board of the Eurasian Economic Commission for pharmaceutical inspectorates cooperation and mutual exchange of experience for the purpose of consolidating single approaches to pharmaceutical inspection of drug manufacturing for compliance with the Rule requirements of the Eurasian Economic Union’s Good Manufacturing Practice.
The inspection took place in the Moscow region at OOO «Firn M», a manufacturer of biotechnological ingredients. Pharmaceutical inspectors from Armenia, Belarus, Kyrgyzstan and Russian participated in the inspection.
As part of this inspection training, inspectorates of member-states of the EAEU were practicing the procedures of mutual exchange procedures with respect to the single approach of the inspection procedure in the following aspects: organization, planning, inspection procedure and result assessment of inspection, that is, approaches to classification of deficiencies.
- What is in the Programme of V GMP-conference?
- The rules of organizing and conducting inspections of drug manufacturers for the compliance with GMP requirements have been changed
- FSI “SID & GP” of the Ministry of Industry and Trade of the Russian Federation and company Sandoz held the first online forum on biotechnologies
- The SID&GP under the auspices of the Ministry of Industry and Trade of the Russian Federation conducted the first online inspection of Roche’s manufacturing site
- Rules for organizing and conducting inspection of pharmaceutical manufacturers for compliance with GMP requirements have been changed