NC Logistic has become the first logistics operator in the Russian pharmaceutical market to receive a GMP certificate. For this purpose, the company has developed its own pharmaceutical quality system that meets regulatory requirements. Now the pharmaceutical manufacturer has the opportunity to store quarantine goods, unsold finished products, raw materials, and auxiliary materials in the operator’s warehouse.
Garold Vlasov, Managing Director of NC Logistic, told GxP News that the project required a lot of work as they had to modernize the warehouse infrastructure, create a production site, analyze regulatory requirements and implement a pharmaceutical quality system.
“We have completely changed the topology of the warehouse in order to combine the work of production and pharmaceutical warehouses”, says Vlasov. “The Quality Department has developed new standard operating procedures (SOPs), industrial regulations and other processes indicating the points of interaction of the pharmaceutical quality system with the existing quality system, as well as carried out the necessary validation measures.”
In addition, the company’s personnel completed a professional development program on drug quality, production and labeling at the I.M. Sechenov First Moscow State Medical University.
All the work carried out made it possible to maximize the integration of the pharmaceutical manufacturer with the logistics provider. The GMP certificate makes it possible not only to store raw materials and auxiliary materials, but also to package and serialize pharmaceutical products, for example, providing foreign companies with the first stage of localization of production.
It is worth noting that obtaining a GMP certificate by a logistics provider opens a new stage of interaction between the operator, the manufacturer, Roszdravnadzor, and the Ministry of Industry and Trade of Russia, since for the first time services controlled by both departments are provided at one warehouse facility and by one legal entity. It is believed that this will make it easier for pharmaceutical companies to organize storage facilities in production areas, since, in cooperation with an operator conforming to the GMP standard, they will not have to enter the address of the remote warehouse into their production license, and, therefore, will not have to undergo additional checks by the regulator.