Regulatory Expectations for Metrics and KPIs

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…

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…

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…

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.…

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…

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…

Examples of KPI Trends in 483 Observations

Examples of KPI Trends in 483 Observations Examples of KPI Trends in 483 Observations In the pharmaceutical and biotech industries, ensuring compliance with regulatory standards is essential. In particular, understanding how to navigate the intricacies of process validation is critical…

Metrics Supporting Process Performance Qualification (PPQ)

Metrics Supporting Process Performance Qualification (PPQ) Metrics Supporting Process Performance Qualification (PPQ) In the pharmaceutical and biologics industries, the validation of processes is crucial for ensuring product quality and compliance with regulatory expectations. This article provides a comprehensive step-by-step tutorial…

Validation Report Audit Checklist: KPIs to Include

Validation Report Audit Checklist: KPIs to Include Validation Report Audit Checklist: KPIs to Include Step 1: Understanding the Validation Lifecycle The validation lifecycle is a structured framework essential for ensuring that processes within pharmaceutical and medical device manufacturing align with…

Linking APR/PQR Reporting to Validation KPI Trends

Linking APR/PQR Reporting to Validation KPI Trends Linking APR/PQR Reporting to Validation KPI Trends In the highly regulated world of pharmaceuticals and medical devices, maintaining compliance while upholding product integrity and safety is paramount. As part of this adherence, companies…