Quality and Compliance

Nikolai Butskii

Deputy director general of external relations

nbutskiy@bcph.com.ua

The pharmaceutical industry is subject to a number of regulations. Our company holds and maintains valid Pharmaceutical Wholesaler’s License  ÀÂ ¹ 599571 which confirms compliance of our processes to local regulation "Pharmaceuticals. Good Distribution Practice. CT-N Ministry of Health 42-5.0: 2014 ".

This document designed to update and harmonize the local regulations according to EU Guidelines of November,5 2013 on Good Distribution Practice of medicinal products for human use (Text with EEA relevance) (2013 / C 343/01)" ("Guidance on November 5, 2013 good practice distribution of medicinal products for human use (Text with EEA relevance to) (2013 / C 343/01)) "(the Guide GDP EC)and successful passing of regular regulatory inspections, customer’s and supplier’s audits.

This regulation enforces strict quality standards on pharmaceutical companies to ensure the safety and benefits of the products distributed by them. Risk assessment based Quality Management in our company insures integrity, continuous improvement of processes and rational resources allocation.