FSI “SID & GP” certified for conformity of the quality control system to international standard requirements ISO 9001:2015 (GOST R ISO 9001-2015)
Certificates for conformity of the quality management system accepted by FSI “SID & GP” to international standard requirements ISO 9001:2015(GOST R ISO 9001-2015) were handed out in a ceremony held on February 9, 2018. Vladislav Shestakov, director of the FSI ‘SID & GP’, received the certificates from Natalya Prokofyeva – a representative of the country’s largest licensing and expert organization “Russian Register” and head of the Russian Register – Baltic Inspection LLC.
The issued ISO certificates are internationally recognized by the Dutch Council for Accreditation (an IAF member) as well as the International certification network IQNet which includes 37 world’s leading certification regulators.
Russian Register’s auditors carried out a two-fold certification of the Institute’s quality management system in November-December 2017 which demonstrated that the system has been successfully developed and implemented in accordance with the annual plan.
“Leadership of your director who ensured effective interaction and involvement of the entire staff in achieving mutual goals, active teamwork aimed at the analysis and improvement of every process in the Institute ensured successful certification and conformity of the Institute’s quality management system with the requirements of ISO 9001: 2015 (GOST R ISO 9001-2015): it is now properly implemented and fully operational “, – said Natalia Prokofieva at the ceremony.
In his turn, Vladislav Shestakov reiterated significance of this event for the Institute, ‘This step that we just made on the road to the Institute’s excellence will no doubt take us to a higher quality level. The certification audit has proven we are moving in the right direction. Let us not forget – however – that we are only in the beginning of the journey: now that the system has been implemented it is of great importance to ensure its seamless operation and integration in all internal processes.’
- The workshop «Risk analysis in planning of validation at pharmaceutical manufacture»
- Fifty experts of the pharmaceutical industry took part in the the expert-advisory workshop «Requirements and application of GMP rules for API manufacture»
- A meeting with the professor of the Sechenov University was held in the State Institute of Drugs and Good Practices
- A meeting of the Council for Professional Qualification in Pharmacy was held in Moscow
- SID & GP – being ahead of time