Metrics and KPIs to Monitor Readiness for Aseptic Inspections and Audits Metrics and KPIs to Monitor Readiness for Aseptic Inspections and Audits Aseptic processing is a critical aspect of pharmaceutical manufacturing, particularly for sterile products. Regulatory agencies such as the FDA and EMA have stringent guidelines governing aseptic manufacturing practices, and non-compliance can lead to significant repercussions, including 483 observations and warning letters. This article provides an in-depth exploration of the metrics and key performance indicators (KPIs) essential for monitoring readiness for aseptic inspections and audits, with a focus on recent findings from FDA and EU inspections. Understanding Aseptic Processing…