Quality: impurities
HumanRegulatory and procedural guidanceQuality of medicinesResearch and developmentScientific guidelines
The European Medicines Agency's scientific guidelines on impurities in drug products and drug substances help medicine developers prepare marketing authorisation applications for human medicines.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
Guidelines
- Control of impurities of pharmacopoeial substances
- ICH Q3A (R2) Impurities in new drug substances
- ICH Q3B (R2) Impurities in new drug products
- ICH Q3C (R9) Residual solvents
- ICH Q3D Elemental impurities
- ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Scientific guideline
- Setting specifications for related impurities in antibiotics