GMP compliance checklist – Pharma GMP

Real-Life Warning Letters for Incomplete Manufacturing Records

digi — Sat, 13 Sep 2025 06:30:45 +0000

Real-Life Warning Letters for Incomplete Manufacturing Records Case Studies: FDA Warning Letters for Incomplete Manufacturing Records Introduction: Why This Topic Matters for GMP Compliance Manufacturing records form the backbone of Good Manufacturing Practice (GMP) compliance. They provide regulators with the evidence that every step of production, testing, and packaging was performed according to approved procedures....

How to Set Up a True Contemporaneous Recording System

digi — Fri, 12 Sep 2025 04:12:10 +0000

How to Set Up a True Contemporaneous Recording System Building a True Contemporaneous Recording System for GMP Compliance Introduction: Why This Topic Matters for GMP Compliance In Good Manufacturing Practice (GMP), documentation is not just a formality—it is evidence that processes were executed as required to ensure product quality and patient safety. A cornerstone of...

GMP Compliance Checklist for New Manufacturing Units

digi — Sun, 07 Sep 2025 04:34:25 +0000

GMP Compliance Checklist for New Manufacturing Units Comprehensive GMP Compliance Checklist for New Pharma Units Introduction: Why This Topic Matters for GMP Compliance Setting up a new pharmaceutical manufacturing unit is a complex process that requires significant planning, investment, and regulatory alignment. Global regulators such as the FDA, EMA, WHO, and PIC/S expect that new...

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...