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ICH Quality Guidelines for Pharmaceutical updated Aug 2020

ICH Quality Guidelines from Q1 to Q14

Q1A    Stability testing of new drug substances and products

Q1B    Stability testing: Photostability testing of new drug substances and products

Q1C    Stability testing for new dosage forms

Q1D    Bracketing and matrixing designs for stability testing of new drug substances and products

Q1E    Evaluation for stability data

Q1F     Stability data package for registration applications in climatic zone III and IV

Q2       Validation of analytical procedures: text and methodology

Q3A    Impurities in new drug substances

Q3B    Impurities in new drug products

Q3C    Impurities: guideline for residual solvents

Q3D Guidelines for elemental impurities

Q3E Assessment and control of Extractables and Leachable for pharmaceuticals and biologics

Q4A-Q4B       Pharmacopoeias

Q5A    Viral safety evaluation of biotechnology products derived from cell lines of human and animal origins.

Q5B    Analysis of the expression construct in cells used for production of r-DNA derived protein products.

Q5C    Quality of biotechnological products: stability testing of biotechnological/biological    products

Q5D    Derivation and characterization of cell substrates used for production of biotechnological/biological products

Q5E    Comparability of biotechnological/biological products subject to changes in their Manufacturing process

Q6A   Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances

Q6B   Specifications: test procedures and acceptance criteria for biotechnological/biological products

Q7 Good Manufacturing practice for API (GMP)

Q8 Pharmaceutical development

Q9 Quality Risk Management (QRM)

Q10 Pharmaceutical Quality System (PQS)

Q11   Development & Manufacture of Drug substance (DMDS)

Q12 Technical & Regulatory Considerations for Pharmaceutical Product Lifecycle Management

Q13 Continuous Manufacturing for Drug Substances and Drug Products

Q14 Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation

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