ICH: quality

The European Medicines Agency publishes scientific guidelines on human medicines that are harmonised by the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

For a complete list of scientific guidelines currently open for consultation, see Public consultations.

• Stability
• Analytical validation
• Impurities
• Regulatory acceptance
• Quality of biotechnological products
• Specifications
• Good manufacturing practice
• Pharmaceutical development
• Lifecycle management

Stability

• ICH Q1A (R2) Stability testing of new drug substances and drug products
• ICH Q1B Photostability testing of new active substances and medicinal products
• ICH Q1C Stability testing: requirements for new dosage forms
• ICH Q1D Bracketing and matrixing designs for stability testing of drug substances and drug products - Scientific guideline
• ICH Q1E Evaluation of stability data
• ICH Q1F Stability data package for registration in climatic zones III and IV

Analytical validation and development

• ICH Q2(R2) Validation of analytical procedures
• ICH Q14 Analytical procedure development

Impurities

• ICH Q3A (R2) Impurities in new drug substances
• ICH Q3B (R2) Impurities in new drug products
• ICH Q3C (R6) Residual solvents
• ICH Q3D Elemental impurities

Regulatory acceptance

• ICH Q4B Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions
• ICH Q4B Annex 1 Residue on ignition/sulphated ash
• ICH Q4B Annex 2 Test for extractable volume in parenteral preparations
• ICH Q4B Annex 3 Test for particulate contamination: sub-visible particles
• ICH Q4B Annex 4A Microbiological examination of non-sterile products: microbial enumeration tests
• ICH Q4B Annex 4B Test for microbiological examination of non-sterile products: tests for specified microorganisms - Scientific guideline
• ICH Q4B Annex 4C Test for microbiological examination of non-sterile products: acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use - Scientific guideline
• ICH Q4B Annex 5 Disintegration test
• ICH Q4B Annex 6 Uniformity of dosage unites general chapter
• ICH Q4B Annex 7 Dissolution test
• ICH Q4B Annex 8 Sterility test
• ICH 4 QB Annex 9 Tablet friability
• ICH Q4B Annex 10 Polyacrylamide gel electrophoresis
• ICH Q4B Annex 11 Capillary electrophoresis
• ICH Q4B Annex 12 Analytical sieving
• ICH Q4B Annex 13 Bulk density and tapped density of powders
• ICH Q4B Annex 14 Bacterial endotoxins tests

Quality of biotechnological products

• ICH Q5A(R2) Guideline on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin - Scientific guideline
• ICH Q5B Analysis of the expression construct in cell lines used for production of rDNA-derived protein products - Scientific guideline
• ICH Q5C Stability testing of biotechnological/biological products
• ICH Q5D Derivation and characterisation of cell substrates used for production of biotechnological/biological products - Scientific guideline
• ICH Q5E Biotechnological/biological products subject to changes in their manufacturing process: comparability of biotechnological/biological products - Scientific guideline

Specifications

• ICH Q6A specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances - Scientific guideline
• ICH Q6B Specifications: test procedures and acceptance criteria for biotechnological/biological products - Scientific guideline

Good manufacturing practice

• ICH Q7 Good manufacturing practice for active pharmaceutical ingredients

Pharmaceutical development

• ICH Q8 (R2) Pharmaceutical development
• ICH Q9 Quality risk management
• ICH Q10 Pharmaceutical quality system
• ICH Q8, Q9 and Q10 - questions and answers
• ICH Q11 Development and manufacture of drug substances (chemical entities and biotechnological/biological entities) - Scientific guideline
• ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Step 2b

Lifecycle management

• ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management