Introduction In the era of Pharma 4.0, the transition from paper-based systems to digital automation is no longer optional. However, for those of us working in Sterile Injectables , this shift brings a unique set of regulatory challenges. Drawing from 11+ years of experience in USFDA, MHRA, and WHO audited facilities, this article explores the critical intersection of GAMP 5 methodology and 21 CFR Part 11 regulations. 1. The "What" vs. The "How": 21 CFR Part 11 and GAMP 5 It is essential to distinguish between regulation and methodology: 21 CFR Part 11 (The Regulation): This FDA rule defines the requirements for electronic records and signatures to be considered trustworthy and equivalent to paper. GAMP 5 (The Methodology): This provides a risk-based framework—the "How-to"—for achieving compliant computerized systems. 2. Key Pillars of CSV Compliance Based on my experience leading CSV projects in FFS (Form-Fill-Seal) lines at...
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