High pharma standards in Rakurs automation
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The seminar “Implementation and Validation of Computerized Systems in the light of FDA 21CFR11 and GxP according to GAMP 5” took place in Rakurs-Engineering Research and Development Centre last week. The training was held as part of Rakurs realization of automation projects for the Russian leading pharmaceutical companies – Geropharm and Biocad.
The seminar lightened the questions of methodology of computerized systems development and implementation for enterprises of pharmaceutical sector. Rakurs specialists were consulted on regulations and instruments, computerized systems validation processes, principals and standard operational procedures.
According to Andrey Sushkov, Director of the Company Engineering Department, new state standards for pharmaceutical sector binding to keep GxP regulations increase requirements to quality and observability of the processes of computerized systems development, implementation and operation. In current projects out specialists use a modern approach based on GAMP5 recommendations which makes this work unique for Russia and Rakurs to be one of the first Russian system integrators working according to the new regulations. Commissioning of Rakurs process automated control system for active pharmaceutical ingredients production for Geropharm company is planned for July 2017.