Process monitoring in pharmaceutical manufacturing encompasses the continuous surveillance, observation, and analysis of key process parameters, variables, and indicators to confirm that manufacturing operations are executed within established limits and adhere to quality specifications and regulatory requirements. This approach includes the real-time or periodic collection, analysis, and interpretation of data to identify deviations, trends, or anomalies potentially impacting process performance or product quality. By facilitating timely intervention, implementation of corrective actions, and necessary process adjustments, effective process monitoring ensures sustained process control, stability, and ongoing compliance with regulatory standards, ultimately guaranteeing the consistent production of pharmaceutical products that meet predefined quality criteria.
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