Tag: Regulatory Expectations for Metrics and KPIs

How to Prepare Validation Metrics for a Regulatory Inspection

How to Prepare Validation Metrics for a Regulatory Inspection How to Prepare Validation Metrics for a Regulatory Inspection Validation metrics play a critical role in the pharmaceutical industry, particularly in ensuring compliance with regulatory requirements, including EU Annex 11, FDA…

Incorporating KPIs in Quality Management Review Meetings

Incorporating KPIs in Quality Management Review Meetings Incorporating KPIs in Quality Management Review Meetings Quality Management Review (QMR) meetings are crucial for ensuring that an organization’s quality management system is effective and meets regulatory requirements. With increasing scrutiny from regulatory…

21 CFR Part 211 and Part 820 Implications on KPI Reporting

21 CFR Part 211 and Part 820 Implications on KPI Reporting 21 CFR Part 211 and Part 820 Implications on KPI Reporting The validation of analytical procedures is a critical component in ensuring the quality and reliability of pharmaceutical products.…

ICH Q10 on Performance Indicators and Process Monitoring

ICH Q10 on Performance Indicators and Process Monitoring ICH Q10 on Performance Indicators and Process Monitoring In the pharmaceutical industry, ensuring that processes are adequately validated is critical for both regulatory compliance and product quality. This comprehensive step-by-step article aims…

EMA and WHO Focus Areas During Validation Metric Audits

EMA and WHO Focus Areas During Validation Metric Audits EMA and WHO Focus Areas During Validation Metric Audits Validation metrics and key performance indicators (KPIs) are crucial in the pharmaceutical industry to ensure compliance with regulatory requirements, particularly during validation…

FDA Expectations for Validation Monitoring and Metrics

FDA Expectations for Validation Monitoring and Metrics FDA Expectations for Validation Monitoring and Metrics In the pharmaceutical and biologics industries, the importance of a robust validation lifecycle cannot be overstated. This article outlines a detailed step-by-step tutorial focusing on the…