Quality guidelines: specifications, analytical procedures and analytical validation
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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.
Analytical validation
- 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
- ICH Q4B Annex 4C Test for microbiological examination of non-sterile products: acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use
- 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