GDP Implementation in Russia, Belarus and Kazakhstan
For long years pharmaceutical industry in Russia has been awaiting implementation of GxP-practices as a legally binding requirement. Start was given at the end of 2013 when GMP was officially put in force in the country based on EU adopted guides.
The major compliance gap was addressed but more questions arose. There were 400+ pharma manufacturers in the country and more than 3000 wholesalers. Obviously having no GDP guide in place put product quality under risk considering how much time medicinal products are circulating within supply chain after leaving a manufacturing site until it’s consumed by a patient. Severe climate conditions and long distances make the case even worse.