SID&GP passed the recertification audit of the Quality Management System according to ISO 9001:2015
In December 2020, SID&GP passed a recertification audit of the Quality Management System for compliance with the requirements of ISO 9001:2015 (national equivalent – GOST R ISO 9001-2015). The previous certificate was issued to the institution in 2018. The branch of the SID&GP – medical unit – also confirmed compliance with international standards.
The standardization system is more than half a century old. Today it has 21,000 standards covering virtually all aspects of business and technology. The most well-known line of standards is ISO 9000. They relate to management practices in manufacturing and business. The ISO 9001 standard was developed in 1984. Today more than a million organizations all over the world are certified according to it. Russia has its national equivalent: GOST R ISO 9001-2015.
“We, ourselves are engaged in auditing and inspecting manufacturers of medicines for compliance with the rules of Good Manufacturing Practices,” says Vladislav Shestakov, Director of SID&GP. – And for this reason the issue pertinent to receiving a certificate for the conformity with the requirements of international quality standards was only a matter of time. Few years ago we have introduced a quality management system in our Institution, then in 2018 we received an ISO certificate, and this year we have successfully affirmed it”.
ISO certificates are developed by experts from all over the world, who have the relevant experience and knowledge in different spheres. The development of ISO standards is done in a way that allows enterprises to function at the optimum level and meet the consumer expectations. ISO certificates are recognized all over the world and with the company holding such certificate, it gives a guarantee that it commits itself to and conforms to the highest quality standards.
Following the results of a re-certification audit, the QMS audit team confirms that FSI “SID & GP” of the Russian Ministry of Industry and Trade and the subsidiary of the FSI “SID & GP” – the Medical unit – have introduced and sustain the quality management system in accordance with the standard ISO 9001:2015 (GOST R ISO 9001-2015) and issue certificate till December, 2023, with an annual confirmation in the form of inspection audits.
- The Cooperation Agreement was signed between State Institute of Drugs and Good Practices and National agency of pharmaceutical products of Algeria
- Russian Federation has submitted an application for the Pharmaceutical Inspection Co-operation Scheme PIC/S accession
- SID&GP experts participated in the ISPE Eurasian Affiliate pre-conference
- Signing of Cooperation agreement between FSI “SID&GP” and Agency for medicinal products and medical devices of Bosnia and Herzegovina
- Director of “SID&GP” has introduced the statistics of identified non-conformities in the registration dossier