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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.

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Q1A - Q1F Stability
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Q2 Analytical Validation
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Q3A - Q3E Impurities
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Q4A - Q4B Pharmacopoeias
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Q5A - Q5E Quality of Biotechnological Products
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Q6A- Q6B Specifications
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Q7 Good Manufacturing Practice
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Q8 Pharmaceutical Development
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Q9 Quality Risk Management
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Q10 Pharmaceutical Quality System
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Q11 Development and Manufacture of Drug Substances
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Q12 Lifecycle Management
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Q13 Continuous Manufacturing of Drug Substances and Drug Products
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Q14 Analytical Procedure Development
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