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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Faster Without Compromise: Reclaiming Capacity on Sterile Fill-Finish Lines
Operational Excellence in Sterile Manufacturing | OEE & Line Productivity Every sterile manufacturing site eventually hits the same wall. Demand rises, the filling line is already booked solid, and the obvious levers (more shifts, more speed) either aren’t available or put sterility assurance at risk. Yet when we study where time actually goes on an… Read more
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Beyond EU GMP Annex 1: Building a Living Contamination Control Strategy That Drives Operational Excellence
Introduction: The Document Is Not the Strategy When the revised EU GMP Annex 1 came into force in August 2023, most sterile manufacturers did the visible work. They wrote the CCS document, mapped it to Section 2, updated the SOPs, and passed the inspection readiness reviews. Yet in many facilities the Contamination Control Strategy (CCS)… Read more
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