Tag: international GMP harmonization

How PIC/S Enhances GMP Harmonization Across Borders

June 13, 2025 digi

How PIC/S Enhances GMP Harmonization Across Borders Enhancing Cross-Border GMP Harmonization Through PIC/S Good Manufacturing Practice (GMP) compliance is the cornerstone of pharmaceutical quality. As the global pharmaceutical landscape becomes increasingly interconnected, the need for consistent inspection standards across borders has never been more crucial. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) plays a transformative role…

International GMP Inspection Standards and Harmonization, PIC/S Role in Harmonized Inspections

EudraLex Volume 4 vs. US FDA 21 CFR: Key Differences in GMP Regulations

June 11, 2025 digi

EudraLex Volume 4 vs. US FDA 21 CFR: Key Differences in GMP Regulations Comparing EudraLex Volume 4 and US FDA 21 CFR: Key Differences in GMP Regulations Pharmaceutical companies operating globally must navigate diverse regulatory landscapes, particularly when manufacturing products for both the European Union and the United States. The two dominant GMP frameworks—EudraLex Volume…

EMA and EU GMP Inspection Practices, International GMP Inspection Standards and Harmonization