Quality is not good enough…….
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My First Blog Post
Create Constancy of Purpose for Improvement Dr.W.Edwards Demming Today 16th July 2019 at 11:00 AM I was just looking at my mail box and received a mail from ASQ , I read it and along with my heart beats going faster, Voila I Cracked the Six Sigma Black Belt Exam. This is great feeling. It’s… Read more
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💉 Injectable Site – Operational Excellence KPI Dashboard
1. 🧪 Quality & Compliance (Critical for Injectable Sites) KPI Definition Target Frequency Owner Batch Rejection Rate % of batches rejected vs total manufactured ≤ 0.5% Monthly QA Head OOS (Out of Specification) No. of OOS per 1000 tests ↓ Trend Weekly QC Head OOS Closure TAT Avg. days to close OOS ≤ 30 days… Read more
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USFDA Inspection Readiness Through Operational Excellence
Building a Culture of Continuous Compliance and Excellence In the global pharmaceutical industry, few moments test an organization’s maturity like an inspection by the U.S. Food and Drug Administration (USFDA). Yet, the most successful organizations no longer view inspections as high-pressure events—they see them as validation of a system that is always in control. “Quality… Read more
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