Tag: target validation in drug discovery

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…

Top CPV Software Systems Used in Pharmaceutical Industry

Top CPV Software Systems Used in Pharmaceutical Industry Top CPV Software Systems Used in Pharmaceutical Industry In the pharmaceutical industry, ensuring the quality and integrity of products throughout their lifecycle is paramount. Continued Process Verification (CPV) plays a crucial role…

Qualification of Isolators and RABS in Sterile Manufacturing

Qualification of Isolators and RABS in Sterile Manufacturing Qualification of Isolators and RABS in Sterile Manufacturing The qualification of isolators and Restricted Access Barrier Systems (RABS) is crucial in maintaining sterile conditions within manufacturing environments. This article outlines a comprehensive,…

FDA, EMA & WHO Guidance on Revalidation Requirements

FDA, EMA & WHO Guidance on Revalidation Requirements FDA, EMA & WHO Guidance on Revalidation Requirements In the pharmaceutical industry, adherence to regulatory requirements for validation is paramount for ensuring that products are consistently produced to a quality standard. This…

ICH Q9 Risk Management Principles Explained Simply

ICH Q9 Risk Management Principles Explained Simply ICH Q9 Risk Management Principles Explained Simply The principles of risk management play a crucial role in the pharmaceutical validation process, particularly concerning the target validation in drug discovery. This comprehensive guide will…

How to Validate Clean Steam Generators and Distribution Lines

How to Validate Clean Steam Generators and Distribution Lines How to Validate Clean Steam Generators and Distribution Lines In the pharmaceutical industry, clean steam generators and their distribution lines play a crucial role in ensuring the integrity of products and…

Challenges in Scaling Process Ranges from Pilot to Commercial Scale

Challenges in Scaling Process Ranges from Pilot to Commercial Scale Challenges in Scaling Process Ranges from Pilot to Commercial Scale In the pharmaceutical industry, the transition from pilot to commercial scale involves a multitude of validation steps that ensure processes…