ICH QUALITY GUIDELINES

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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

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