Tag: trending temperature excursions

Validation Metrics to Monitor Equipment Performance Over Time

Introduction: Why Validation Metrics Matter in Pharma In pharmaceutical manufacturing and stability testing, equipment validation is not a one-time activity. Monitoring the long-term performance of validated equipment is essential to ensure it continues to operate within qualified parameters. This article focuses on validation metrics — measurable indicators that QA and engineering teams can track to…

Equipment and Calibration, Validation of Stability Testing Equipment

Regulatory Expectations for Excursion Trending and CAPA Effectiveness

In pharmaceutical stability programs, repeated temperature or humidity excursions are not just isolated incidents — they may signal systemic weaknesses. Regulatory authorities such as the USFDA and EMA expect robust trending and effective corrective and preventive actions (CAPA) to prevent recurrence. This article outlines regulatory expectations and practical strategies for trending excursions and verifying CAPA…

Handling Deviations and CAPA in Stability Reports, Protocols and Reports