ICH Guidelines for Quality

Quality Guidelines

Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.

Q1A - Q1F Stability

Q2 Analytical Validation

Q3A - Q3E Impurities

Q4A - Q4B Pharmacopoeias

Q5A - Q5E Quality of Biotechnological Products

Q6A- Q6B Specifications

Q7 Good Manufacturing Practice

Q8 Pharmaceutical Development

Q9 Quality Risk Management

Q10 Pharmaceutical Quality System

Q11 Development and Manufacture of Drug Substances

Q12 Lifecycle Management

Q13 Continuous Manufacturing of Drug Substances and Drug Products

Q14 Analytical Procedure Development

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