The performance of stability studies, establishing appropriate thresholds for impurity testing, and a more sensible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk assessment are all significant milestones in the harmonisation of the Quality domain.
Q1A-Q1F: Stability
Q1A: Stability testing of new drugs substance and products.
Q1B: Stability testing: Photo stability testing of new drugs.
Q1C: Stability testing of new dosage form
Q1D: Bracking and mixing design for stability testing of drug substance and product.
Q1E: Evaluation of stability data.
Q1F: Stability data packages for registration.
Q2A-Q2B: Analytical Validation
Q2A: DEFINTIONS AND TERMINOLOGY: ANALYTICAL VALIDATION
Q2B: METHODOLOGY
Q3A-Q3D: Impurities
Q3A: Impurities in new drug substance
Q3B: Impurities in new drug product
Q3C: Impurities guideline for residual solvent.
Q3D: Implementation of guidelines for element impurities..
Q4-Q4B: Pharmacopoeias
Q4: Pharmacopoeias
Q4A: Pharmacopoeial Harmonization
Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.
Q5A-Q5E: Quality of Biotechnological Products
Q5A: Viral safety evaluation of biotechnologically product.
Q5B: Analysis of expression constant in cells used for production of r-DNA derived from protein product
Q5C; Stability testing of biotechnologically product.
Q5D: Derivation and characterization of cell substrate used for production of biotechnological
Q5E: Comparability of biotechnological product.
Q6A-Q6B: Specifications
Q6A: Test procedure and acceptance criteria for new drug substance and new drug product.
Q6B: Testing reduce the need to duplicate the development of new medicine by recommending way to achieve greater harmonization in the interpretation and application of technical guidelines.
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
