iso 14644 1 2015 – Pharma Validation

CAPA Triggers from CPV Reports: When to Intervene

CAPA Triggers from CPV Reports: When to Intervene CAPA Triggers from CPV Reports: When to Intervene Continued Process Verification (CPV) is a critical component of an integrated quality management system in pharmaceutical manufacturing. This article provides a detailed step-by-step tutorial…

Airflow Visualization (Smoke Studies) for Aseptic Line Qualification

Airflow Visualization (Smoke Studies) for Aseptic Line Qualification Airflow Visualization (Smoke Studies) for Aseptic Line Qualification Airflow visualization studies, commonly referred to as smoke studies, play a crucial role in the aseptic line qualification process. Employing an established method such…

How to Cross-Reference Change Controls in Revalidation Reports

How to Cross-Reference Change Controls in Revalidation Reports How to Cross-Reference Change Controls in Revalidation Reports In the pharmaceutical industry, ensuring compliance with regulatory requirements while maintaining product quality is of paramount importance. The process validation lifecycle is fundamental in…

Risk-Based Revalidation: How to Optimize Your Schedule

Risk-Based Revalidation: How to Optimize Your Schedule Risk-Based Revalidation: How to Optimize Your Schedule In the world of pharmaceutical manufacturing, quality assurance and compliance with regulatory standards are paramount. One critical aspect of maintaining product quality is the validation process,…

Calculating LOD and LOQ for HPLC and UV Methods

Calculating LOD and LOQ for HPLC and UV Methods Calculating LOD and LOQ for HPLC and UV Methods In the realm of analytical method validation, determining the Limit of Detection (LOD) and Limit of Quantification (LOQ) is critical for ensuring…

Flow, Pressure, and Dew Point Testing in Gas Systems

Flow, Pressure, and Dew Point Testing in Gas Systems Flow, Pressure, and Dew Point Testing in Gas Systems In the pharmaceutical sector, ensuring the integrity and reliability of gas systems is critical for compliance with regulatory standards. Specifically, ISO 14644-1:2015…

How to Justify Process Ranges Using Scientific Data

How to Justify Process Ranges Using Scientific Data How to Justify Process Ranges Using Scientific Data Justifying process ranges is a critical component of validation in quality assurance in pharmaceutical and biologics manufacturing. It involves a systematic approach to determine…