FSI “SID and GP” of the Russian Ministry of Industry and Trade became the winner of the SCM Pharm award

 
FSI “SID and GP” of the Russian Ministry of Industry and Trade and PQE CIS became winners of the SCM Pharm award in the Quality Project of the Year category, presenting a joint development, i.e. the guidelines on “Integrity Data and Validation of Computer Systems”. 

The team of authors of the Guide includes: V.N. Shestakov, N.N. Chadova, T.V. Nikolko, I.V. Falkovsky, N.B. Arkhipova, M.M. Sottaeva, V.V. Gorychkin, S.V. Orlov, V.A. Orlov, Gilda D’Incerti, Danilo Neri, and Yu.A. Sandler. It has been available to wide audience since 2018, and in 2022 it was approved by the Working Group of the Eurasian Economic Commission on the formation of common approaches to phamaceutical regulation within the Eurasian Economic Union.

In total, six projects were submitted in the Quality Project of the Year category, two of which scored the maximum number of points: these are the project by the Federal State Institution “SID and GP” of the Ministry of Industry and Trade of Russia jointly with PQE CIS and the project by the S.M. Kirov Military Medical Academy. 

The guidelines were created with the aim of developing the GMP rules of the Eurasian Economic Union, and, according to the working groups of the EEC and the ISPE Eurasian Economic Union Affiliate, will ensure:

• the effectiveness of inspection processes for assessing the compliance of pharmaceutical manufacturers with GxP requirements, based on the authenticity of the documents provided, and, ultimately, on the integrity of the initial data;
• providing consolidated, visual guidelines to regulated companies on risk-based control strategies based on compliance with data integrity and reliability requirements in the context of modern industry practices;
• support for the efficient implementation of data integrity elements in the planning and realisation of the qualification process for GxP critical suppliers;
• Replenishment of the procedural base corresponding to the regulatory requirements for the management of computerized systems set out in Annex 11 to the GMP Rules of the EAEU (Decision No. 77 of November 3, 2016 of the Council of the Eurasian Economic Commission).

You can read the Guidelines on the website of the FSI “SID and GP” https://gilsinp.ru/?page_id=4818