Tag: continuous process validation

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…

Visual Dashboards for CPV Stakeholders

Visual Dashboards for CPV Stakeholders Visual Dashboards for CPV Stakeholders In the highly regulated pharmaceutical industry, ensuring product quality and compliance with Good Manufacturing Practices (GMP) is paramount. Continuous Process Validation (CPV) aims to monitor and ensure that pharmaceutical processes…

Case Study: Aseptic Process PQ Failures and CAPA

Case Study: Aseptic Process PQ Failures and CAPA Case Study: Aseptic Process PQ Failures and CAPA This article provides a detailed guide on continuous process validation (CPV) within the context of aseptic processes, focusing on understanding process validation lifecycle steps.…

Tracking Revalidation Requirements Through the Product Lifecycle

Tracking Revalidation Requirements Through the Product Lifecycle Tracking Revalidation Requirements Through the Product Lifecycle In the ever-evolving landscape of pharmaceutical and biologics manufacturing, maintaining consistent quality and compliance is paramount. Continuous Process Validation (CPV) is a proactive approach that emphasizes…

Impact of Risk-Based Approaches on Cost and Resources

Impact of Risk-Based Approaches on Cost and Resources Impact of Risk-Based Approaches on Cost and Resources In the evolving landscape of pharmaceutical development, the application of risk-based approaches to process validation has emerged as an essential strategy. This step-by-step tutorial…

Determining LOD and LOQ for API vs Finished Product Analysis

Determining LOD and LOQ for API vs Finished Product Analysis Determining LOD and LOQ for API vs Finished Product Analysis Step 1: Understanding User Requirements Specifications (URS) and Conducting a Risk Assessment The first essential step in the validation lifecycle…

Filter Validation in Compressed Air and Nitrogen Systems

Filter Validation in Compressed Air and Nitrogen Systems Filter Validation in Compressed Air and Nitrogen Systems Filter validation plays a critical role in ensuring the integrity and quality of compressed air and nitrogen systems used in pharmaceutical and biologics manufacturing.…

Impact of Raw Material Variability on Process Capability

Impact of Raw Material Variability on Process Capability Impact of Raw Material Variability on Process Capability The pharmaceutical industry is governed by stringent regulations designed to ensure the safety, efficacy, and quality of products. A significant factor in ensuring product…