ICH Q2(R2) Guide: Analytical Method Validation Explained
Understand analytical method validation with this deep dive into ICH Q2(R2). Explore validation parameters, documentation, and the new QbD lifecycle approach wi
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Articles tagged with “pharmaceutical-quality”
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)
ISO 9001 in Biotech: A Guide to Relevance & Compliance
Is ISO 9001 still used in biotech? This guide analyzes how the QMS standard supports regulatory compliance, complements GMP, and improves quality in pharma & li
Good Manufacturing Practice (GMP): Pharma Quality Assurance Guide
Explore Good Manufacturing Practice (GMP) in pharma. Learn its principles, global regulations, implementation, and compliance challenges for quality assurance.