Quality: specifications, analytical procedures and analytical validation
Table of contents
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.
- ICH Q2(R2) Validation of analytical procedures - Scientific guideline
- ICH Q4B Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions - Scientific guideline
- ICH Q4B Annex 1 Residue on ignition/sulphated ash - Scientific guideline
- ICH Q4B Annex 2 Test for extractable volume in parenteral preparations - Scientific guideline
- ICH Q4B Annex 3 Test for particulate contamination: sub-visible particles - Scientific guideline
- ICH Q4B Annex 4A Microbiological examination of non-sterile products: microbial enumeration tests - Scientific guideline
- 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 - Scientific guideline
- ICH Q4B Annex 6 Uniformity of dosage unites general chapter - Scientific guideline
- ICH Q4B Annex 7 Dissolution test - Scientific guideline
- ICH Q4B Annex 8 Sterility test - Scientific guideline
- ICH 4 QB Annex 9 Tablet friability - Scientific guideline
- ICH Q4B Annex 10 Polyacrylamide gel electrophoresis - Scientific guideline
- ICH Q4B Annex 11 Capillary electrophoresis - Scientific guideline
- ICH Q4B Annex 12 Analytical sieving - Scientific guideline
- ICH Q4B Annex 13 Bulk density and tapped density of powders - Scientific guideline
- ICH Q4B Annex 14 Bacterial endotoxins tests - Scientific guideline
- Use of near infrared spectroscopy (NIRS) by the pharmaceutical industry and the data requirements for new submissions and variations - Scientific guideline