Quality: specifications, analytical procedures and analytical validation
HumanRegulatory and procedural guidanceQuality of medicinesResearch and developmentScientific guidelines
The European Medicines Agency's scientific guidelines on specifications, analytical procedures and analytical validation help medicine developers prepare marketing authorisation applications for human medicines.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
Specifications
Analytical validation
Guidelines
- ICH Q2 (R1) Validation of analytical procedures: text and methodology
- 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
- Use of near infrared spectroscopy (NIRS) by the pharmaceutical industry and the data requirements for new submissions and variations - Scientific guideline