Construction of a Prefabricated Modular Building for a Thermal Disinfection and Decontamination Station for Pathogenicity Groups III–IV Effluents

INEX specialists were invited to participate in the CAPA examination of the facilities of NIRC BIOLIFE LLC. CAPA - corrective and preventive actions, the procedure involves monitoring operating systems, taking comments and drawing up a corrective CAPA plan. The CAPA methodology aims to identify and eliminate potential inconsistencies and risks. The procedure is carried out as part of an unscheduled inspection of the facilities of NIRC BIOLIFE LLC, the contractor is the State Institute of Medicines and Good Practices (FSI SID and NP), on behalf of the Ministry of Industry and Trade of Russia (Order of the Ministry of Trade and Trade of the Russian Federation No. 589 dated February 25, 2022 Biolife Laboratories occupy a leading position in the market in the field of confirming the quality and safety of manufactured and put into circulation medicines, medical equipment, biologically active additives, perfumes and cosmetics, reagents for in vitro diagnostics. As part of the ongoing examination and monitoring of CAPA, a number of working meetings were held with specialists from NIRC BIOLIFE LLC and an expert from the Research Institute of Poliomyelitis and Viral Encephalitis named after V.I. M. P. Chumakov. The CAPA examination and the development of new requirements determine the growth in the efficiency and quality of laboratory research, and also form new technological standards in the industry. The comments taken and the corrective plan allowed INEX specialists to make the necessary changes to the project documentation and planning solutions for the new microbiological laboratory.