Tag: FDA guidelines

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…

Forecasting Revalidation Needs Using Historical Metrics

Forecasting Revalidation Needs Using Historical Metrics Forecasting Revalidation Needs Using Historical Metrics Step 1: Understanding User Requirements Specifications (URS) & Risk Assessment In the validation lifecycle, establishing a solid foundation begins with thorough User Requirements Specifications (URS) and an accompanying…

Validation Failure Reduction Through Trend Monitoring

Validation Failure Reduction Through Trend Monitoring Validation Failure Reduction Through Trend Monitoring In the dynamically evolving pharmaceutical landscape, validation practices play a pivotal role in ensuring product quality, compliance, and patient safety. This step-by-step guide offers pharmaceutical professionals a comprehensive…

KPI Heatmaps for Multi-Product Validation Facilities

KPI Heatmaps for Multi-Product Validation Facilities KPI Heatmaps for Multi-Product Validation Facilities Step 1: Understand User Requirements Specification (URS) and Risk Assessment The foundation of any validation effort lies in understanding and documenting User Requirements Specifications (URS). URS outlines the…

Linking Trending Data with Process Lifecycle Updates

Linking Trending Data with Process Lifecycle Updates Linking Trending Data with Process Lifecycle Updates In the highly regulated pharmaceutical industry, maintaining compliance through validated systems is essential. This tutorial systematically outlines the validation lifecycle with a focus on equipment validation…

Trend Analysis of Hold Time Study Failures

Trend Analysis of Hold Time Study Failures Trend Analysis of Hold Time Study Failures In the pharmaceutical and biologics industries, maintaining the integrity and quality of products throughout their lifecycle is essential. Hold time studies are a critical component of…

Corrective Action Trends as a KPI for Validation Health

Corrective Action Trends as a KPI for Validation Health Corrective Action Trends as a KPI for Validation Health In the pharmaceutical industry, maintaining product quality is paramount. Continuous process validation (CPV) plays a crucial role in ensuring that processes remain…

Incorporating Risk-Based Trending in Validation Reporting

Incorporating Risk-Based Trending in Validation Reporting Incorporating Risk-Based Trending in Validation Reporting In the world of pharmaceuticals, validation is a critical component that ensures processes are robust, consistent, and compliant with regulatory expectations. Central to validation is the approach known…

How to Use CPV Data to Update KPIs and Metrics

How to Use CPV Data to Update KPIs and Metrics How to Use CPV Data to Update KPIs and Metrics In the pharmaceutical industry, ensuring compliance with regulatory principles while maintaining high-quality outputs is paramount. Continuous Process Validation (CPV) is…