Tag: ppq pharma

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…

Key Performance Indicators (KPIs) for CPV Program Health

Key Performance Indicators (KPIs) for CPV Program Health Key Performance Indicators (KPIs) for CPV Program Health Effective management of pharmaceutical manufacturing processes is crucial to ensure product quality, patient safety, and regulatory compliance. Continued Process Verification (CPV) plays a pivotal…

QA Review of Aseptic Process Qualification Protocols

QA Review of Aseptic Process Qualification Protocols QA Review of Aseptic Process Qualification Protocols In the pharmaceutical and biopharmaceutical industries, ensuring the efficacy and safety of drug products is paramount. One critical component of this assurance is the validation of…

Managing Validation Status Tags Post-Revalidation

Managing Validation Status Tags Post-Revalidation Managing Validation Status Tags Post-Revalidation In the pharmaceutical industry, effective validation processes are critical to ensuring compliance with Good Manufacturing Practices (GMP) and maintaining product quality. This step-by-step tutorial provides insight into managing validation status…

Real-Life Applications of ICH Q9 in Pharma Validation

Real-Life Applications of ICH Q9 in Pharma Validation Real-Life Applications of ICH Q9 in Pharma Validation In the highly regulated pharmaceutical industry, validation processes ensure that products meet both quality and regulatory standards. ICH Q9 outlines a risk-based approach essential…

ICH Q2 Guidance on Reporting LOD and LOQ Values

ICH Q2 Guidance on Reporting LOD and LOQ Values ICH Q2 Guidance on Reporting LOD and LOQ Values In the modern pharmaceutical landscape, establishing reliable analytical methods is crucial for ensuring product quality and regulatory compliance. This step-by-step validation tutorial…

Alarm and Interlock Testing for Gas Supply Systems

Alarm and Interlock Testing for Gas Supply Systems Alarm and Interlock Testing for Gas Supply Systems In the pharmaceutical industry, ensuring the reliability and safety of gas supply systems is critical for maintaining compliance with Good Manufacturing Practices (GMP). This…

Bridging Development Data to Commercial Range Justification

Bridging Development Data to Commercial Range Justification Bridging Development Data to Commercial Range Justification Validation is a critical component of pharmaceutical development and production, ensuring that processes yield products that meet predefined quality requirements consistently. This article serves as a…