ISPE D/A/CH Workshop: Data Science Assisted Biopharmaceutical Tech Transfer and Process Characterization
ISPE D/A/CH Workshop: Data Science Assisted Biopharmaceutical Tech Transfer and Process Characterization
Biopharmaceutical Processes Process Validation Process Characterization Studies (Stage 1) Validation and Technology Transfer Problem Statement Regulatory expectations for statistically underpinned Process Validation (PV) has found its way into current guidelines such as the FDA’s life cycle approach to process validation from 2011 leading to demonstrating Established Conditions (ECs) in ICH Q12. However, specific critical components […]