How Companies Can Prepare for a PIC/S-Led Inspection

digi — Sun, 15 Jun 2025 20:25:47 +0000

How Companies Can Prepare for a PIC/S-Led Inspection Preparing Your Company for a Successful PIC/S GMP Inspection A Pharmaceutical Inspection Co-operation Scheme (PIC/S)-led inspection is a significant event for any pharmaceutical company. These inspections are conducted by competent authorities from member countries, applying harmonized Good Manufacturing Practice (GMP) standards across the globe. Success depends on...

US FDA Inspection Preparation Checklist

digi — Thu, 05 Jun 2025 08:36:10 +0000

US FDA Inspection Preparation Checklist Essential Checklist for Preparing Your Facility for a US FDA Inspection US FDA inspections are a pivotal part of regulatory oversight, determining a pharmaceutical facility’s compliance with Current Good Manufacturing Practices (cGMP) under 21 CFR Parts 210 and 211. Being prepared is not just about documentation—it’s about demonstrating control, traceability,...

GMP inspection SOPs – Pharma GMP

How Companies Can Prepare for a PIC/S-Led Inspection

US FDA Inspection Preparation Checklist