process performance qualification

First-Time Right (FTR) Metric in Validation Execution

First-Time Right (FTR) Metric in Validation Execution First-Time Right (FTR) Metric in Validation Execution The concept of First-Time Right (FTR) is fundamental in the pharmaceutical validation landscape. The FTR metric is crucial for evaluating the effectiveness of process performance qualification…

How to Define Sampling Frequency in CPV Lifecycle

How to Define Sampling Frequency in CPV Lifecycle How to Define Sampling Frequency in CPV Lifecycle Continued Process Verification (CPV) is an essential aspect of the pharmaceutical manufacturing lifecycle, ensuring that processes remain in a state of control after the…

Interventions During Media Fill: Classification and Frequency

Interventions During Media Fill: Classification and Frequency Interventions During Media Fill: Classification and Frequency The aseptic manufacturing process is a critical component in the production of sterile pharmaceutical products. Adherence to regulatory expectations and thorough validation practices is essential for…

How to Document Revalidation Justifications in QA Systems

How to Document Revalidation Justifications in QA Systems How to Document Revalidation Justifications in QA Systems The validation lifecycle in the pharmaceutical industry is a critical process that ensures product quality and compliance with regulatory requirements. This article serves as…

How to Apply FTA in Utility and HVAC Risk Scenarios

How to Apply FTA in Utility and HVAC Risk Scenarios How to Apply FTA in Utility and HVAC Risk Scenarios In the pharmaceutical industry, validating processes is a critical step to ensure quality and compliance with regulatory requirements. One essential…

Calculating %RSD for Precision Studies in Method Validation

Calculating %RSD for Precision Studies in Method Validation Calculating %RSD for Precision Studies in Method Validation In the pharmaceutical and biotechnology sectors, ensuring the reliability and accuracy of analytical methods is crucial for meeting regulatory requirements. One of the central…

HVAC System Monitoring Parameters: What to Track and Why

HVAC System Monitoring Parameters: What to Track and Why HVAC System Monitoring Parameters: What to Track and Why In the pharmaceutical industry, maintaining a controlled environment is critical for product quality, safety, and compliance with regulatory standards. HVAC systems play…

How to Establish Hold Time for In-Process Materials

How to Establish Hold Time for In-Process Materials How to Establish Hold Time for In-Process Materials The establishment of hold times for in-process materials is a critical component of the overall process validation lifecycle within the pharmaceutical industry. This process…