Tag: PIC/S updates 2025
PIC/S Guidance Explained: Complete Guide to GMP Compliance, Inspections, and Global Harmonization
PIC/S Guidance Explained: Complete Guide to GMP Compliance, Inspections, and Global Harmonization Ultimate Guide to PIC/S Guidance for GMP Compliance and Global Regulatory Harmonization Introduction to PIC/S Guidance and Its Importance The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is an international framework designed to harmonize Good Manufacturing Practice (GMP) standards and strengthen cooperation between pharmaceutical inspectorates worldwide. Established in 1995, PIC/S today has over 50 participating authorities, including the US FDA, EMA, and regulatory bodies in Asia, Europe, and Latin America. PIC/S guidance is built around inspector training, GMP standardization, and mutual recognition of inspections, thereby reducing duplication of audits. For…
