Validations: Changeovers, Speeds & CPV

OEE & FPY: KPIs That Matter in Packaging OEE & FPY: KPIs That Matter in Packaging The pharmaceutical industry is highly regulated and demands a rigorous approach to validate packaging processes. Key Performance Indicators (KPIs) such as Overall Equipment Effectiveness (OEE) and First Pass Yield (FPY) are critical metrics to ensure every step of the packaging process meets standards set…

Start-Up/End-of-Run Controls: Capture the Edges Start-Up/End-of-Run Controls: Capture the Edges In the pharmaceutical industry, packaging process validation is a critical component to ensure product quality and compliance with regulatory standards. This comprehensive guide outlines the various aspects of start-up and end-of-run controls, focusing on sealer crimper qualification, heat seal parameters, label print verification, OCR/OCV methods, and continued process verification (CPV)….

Crew Size, Training & Human Factors in Changeovers Crew Size, Training & Human Factors in Changeovers In the pharmaceutical industry, changeovers are critical for ensuring the integrity of packaging processes. This article provides a comprehensive step-by-step tutorial on the essential components of packaging process validation, focusing on crew size, training, and human factors during changeovers. This guide is designed for…

Changeover Validation: From SMED Concepts to GxP Evidence Changeover Validation: From SMED Concepts to GxP Evidence Changeover validation is a critical component in the packaging process within the pharmaceutical industry. It ensures that equipment and processes are capable of producing consistently high-quality products during format changes. This article provides a comprehensive, step-by-step guide on establishing effective changeover validation practices focused…