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.