Process Validation for Biotech: A PPQ & CPV Guide
Learn the lifecycle approach to biotech process validation. This guide covers PPQ and CPV planning, execution, and monitoring based on FDA, EMA, and ICH guidanc
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Articles tagged with “quality-by-design-qbd”
Machine Learning for CMC Process Optimization: A Guide
Learn how machine learning (ML) and AI are used for pharmaceutical CMC process optimization. This guide covers applications, data challenges, and case studies.
Guide to ICH Q7, Q8, & Q9: GMP, QbD, and QRM Standards
A comprehensive 2025 guide to ICH Q7, Q8, & Q9. Learn the core principles of GMP for APIs (Q7), Quality by Design/QbD (Q8), and Quality Risk Management/QRM (Q9)