Quality: specifications, analytical procedures and analytical validation

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

• ICH Q6A specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances
• Specifications and control tests on the finished product
• Dissolution specification for generic oral immediate release products

Q & A on implementation of Ph.Eur. Medicinal Product Monographs

Reference Number: EMA/CHMP/QWP/505156/2023

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

Other

• Real time release testing