FBU “GILLS and NP” held the first online inspection of pharmaceutical production

Russian state GMP Inspectorate conducted the first online on Swiss plant Roche (Basel), which produces drugs for the treatment of cancer, spinal muscular atrophy and flu. This is the first inspection for the international manufacturing sites whose products are supplied to Russia.

As usual, visual inspection of the production was carried out by two inspectors with the participation of representatives of Roche. Within two days of the five allotted for the inspection, was conducted online inspection of production areas, in accordance with the plan of the production site and plan inspections. The manufacturer was demonstrated industrial premises, zones of storage of pharmaceutical substances, finished dosage drugs, weighing of raw materials, laboratory internal monitoring and control of microbiological purity of medicines, area engineering systems and auxiliary areas (water and vazduhopolovna). Also presents information on the functioning and maintenance of engineering systems.

The Inspectorate of the FBI “GEELS and NP” of the Ministry of industry and trade believes that the online inspection is an interim measure and will not be able in the future to completely replace the inspection of the courts at the place of implementation of activities. This requirement is fixed in all the recommendations of international regulators, in particular, in recommendation of the European medicines Agency EMA/572454/2014 Rev 17 Compliance and Inspection Compilation of Community Procedures on Inspections and Exchange of Information, PIC/S PI 048-1 1 June 2018 GMP INSPECTION RELIANCE.

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