Validations: Metrology KPIs & Governance
Dashboards for Calibration Programs: What to Show Dashboards for Calibration Programs: What to Show In the highly regulated pharmaceutical industry, ensuring the accuracy and reliability of measurement systems is critical. Calibration programs serve as the backbone for maintaining compliance with Good Manufacturing Practices (GMP) outlined by regulators like the US FDA, EMA, and MHRA. This article provides a comprehensive guide…
Work Order Backlog & Cycle Time: Managing the Queue Work Order Backlog & Cycle Time: Managing the Queue In the pharmaceutical industry, effective calibration and metrology practices are vital for ensuring compliance with regulatory requirements and maintaining the integrity of laboratory results. Issues surrounding work order backlog and cycle time can significantly affect the calibration program’s efficiency and its ability…
On-Time Calibration: Guardrails and Escalations Introduction to Calibration in the Pharmaceutical Industry Calibration is a critical component in maintaining the integrity of measurements within the pharmaceutical industry. It ensures that instruments provide accurate and reliable data, which is essential in the development and manufacturing processes. The regulatory framework set by agencies such as the US FDA and EMA mandates that…
Planned vs Unplanned Downtime: Metrics and Controls Planned vs Unplanned Downtime: Metrics and Controls 1. Introduction to Calibration and Measurement Uncertainty In the pharmaceutical industry, proper calibration and measurement are crucial for ensuring the accuracy and reliability of equipment used in manufacturing, testing, and quality control. Effective calibration management incorporates not only the calibration interval and associated documentation but also…
First-Time Right in Calibration: What Drives It First-Time Right in Calibration: What Drives It In the highly regulated pharmaceutical environment, establishing a robust calibration program is essential for ensuring the accuracy and reliability of measurement systems. Calibration underpins compliance with stringent requirements mandated by authorities such as the FDA, EMA, and MHRA. This comprehensive tutorial provides a step-by-step approach to…
Metrology KPI Set: OTD, OOT Rate, MU Coverage, and More Metrology KPI Set: OTD, OOT Rate, MU Coverage, and More In the pharmaceutical industry, the accuracy of measurements and the reliability of equipment are paramount to ensuring product quality and compliance with regulatory requirements. Effective management of calibration and metrology activities is essential for maintaining the integrity of measurement systems…