On 29.06.2021 ANO NSC of Pharmacovigilance together with “Zavod Medsintez” LLC conducted an audit*, the scope of which was critical processes of pharmacovigilance.
Medsintez pharma plant specializes in the production of pharmaceutical products and devices
The company produces infusion solutions, finished dosage forms and human insulin substances, solid and liquid dosage forms. “Medsintez” is one of the first Russian industrial manufacturers of finished dosage forms of genetically engineered human insulin that meet GMP EU requirements.
*PharmacovigilanceSystem Audit(PSA) is a systematic, structured, and independent audit of the system to obtain objective and documented information describing its quality. As a rule, PSA is part of a quality system audit, so before conducting the audit, indicators should be defined in advance, by which the performance of the pharmacovigilancesystem is evaluated.