In July «BioEq» has successfully passed a 2-days audit of a multinational company (one of the top-10 Pharma). The audit was conducted by the company representative and an external auditor from Germany. The purpose was to evaluate «BioEq» as a phase I and bioequivalence unit.
During the audit Sponsor’s representatives examined the center thoroughly: wards for volunteers, an intensive care unit, examination rooms, treatment rooms, a biosamples handling room, a laboratory, an archive, a warehouse and a pharmacy. They have also investigated the processes of the unit applicable for Phase I studies and Bioequivalence studies conduct, interactions with Local Ethics Committee and thoroughly studied the internal Standard Operating Procedures (SOPs).
Auditors were satisfied with the unit and its operating procedures. As a result of the audit no major findings were identified.
«BioEq» has already successfully passed over 10 audits as a Phase I and Bioequivalence unit including a regulatory body inspection – RosZdravNadzor (the Federal Service on Surveillance in Healthcare of the Russian Federation). No major findings were identified at any of the audits/inspections.