New GDP Rules in Russia - what you need to know

Recommendation

4/5 February 2020
Prague, Czech Republic

GDP for Beginners

The new GDP rules published in Russia last year have been valid since 1 March 2017. They do of course apply to companies in Russia, but also pharmaceutical companies distributing to Russia should be aware of the new rules on storage and transportation. Companies operating in Russia are now also responsible for ensuring that any contract warehouses and other third party services do meet the same requirements.

So with these new rules which are similar to the EU and PIC/S GDP guidelines, pharmaceutical manufacturers, distributors and warehouses should check their existing quality systems and implement or provide for example:

• Initial and on-going training for all employees involved in GDP
• GDP compliant quality system and standard operating procedures in place
• GDP compliant documentation, record-keeping and reporting
• Separate storage areas for counterfeit medicines
• Appointing a person being responsible for implementing and maintaining the quality system and monitoring its compliance and efficiency
• Monitoring compliance of third party logistic providers and warehouses (including audits)

This Code of Good Practice in the Pharmaceutical Industry is also available in English.