2024 Key Achievements
30.04.2025
Quality Management System for Reference Material Handling
14.05.2025
Andrey Arkadievich Berman, General Director of NCRS, provided commentary to GxP News regarding pharmaceutical manufacturers' use of imported reference standards.
Quality Control at Risk
Geopolitical tensions intensify the need for supply chain localization
Establishing a domestic reference materials database represents a strategic national priority
NCRS is actively expanding its line of domestic reference standards for quality control of active pharmaceutical ingredients (APIs), impurities, and excipients. Current priorities include developing impurity reference compounds for existing INNs. NCRS's portfolio now comprises approximately 250 reference materials, with plans to expand the range to include substances beyond the Essential Medicines List.
The key objectives of Russia's "Pharma-2030
Implementation Challenges and Strategic Solutions for Domestic Reference Standard Adoption
Andrey Arkadievich Berman highlighted both the root causes of the current challenges and actionable solutions to address them.
Why are manufacturers reluctant to adopt domestic reference standards?
Underestimated Advantages of Domestic Reference materials
Regulatory Hurdles and Market Awareness Challenges
Persisting skepticism toward domestic reference materials stems partly from regulatory ambiguities and practitioners' limited awareness. Documented instances exist of misinterpretations regarding the approved-type reference material status.
We maintain that resolving regulatory inconsistencies and enhancing manufacturer education constitute the critical pathway for transitioning to new standards and reducing reliance on imported solutions.
