"How to verify EU GMP compliance vs US cGMP?"
European GMP regulations (EU Directive 2003/94/EC and EudraLex Volume 4) enforce stringent validation of environmental air cleanliness, water purification (PW/WFI systems), and raw material identity testing compared to standard FDA 21 CFR Part 111 rules. Nutrikal provides validated batch record execution (MBR) and analytical CoAs compatible with both EU and US FDA import enforcement agencies.