Tag: FDA guidelines

Presenting KPI Dashboards to Regulatory Agencies

Presenting KPI Dashboards to Regulatory Agencies Presenting KPI Dashboards to Regulatory Agencies In the highly regulated pharmaceutical industry, presenting Key Performance Indicator (KPI) dashboards effectively to regulatory agencies is crucial for compliance and operational excellence. This article will provide a…

Risk-Based KPI Justification for Critical Validation Areas

Risk-Based KPI Justification for Critical Validation Areas Risk-Based KPI Justification for Critical Validation Areas The validation lifecycle in pharmaceutical manufacturing encompasses several critical steps designed to ensure compliance with regulatory expectations and maintain product quality. Among these steps, a focus…

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…

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…

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…

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…

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…