Quality: stability
HumanRegulatory and procedural guidanceQuality of medicinesResearch and developmentScientific guidelines
The European Medicines Agency's scientific guidelines on the stability of drug substances and drug products 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
- ICH Q1A (R2) Stability testing of new drug substances and drug products
- ICH Q1B Photostability testing of new active substances and medicinal products
- ICH Q1C Stability testing: requirements for new dosage forms
- ICH Q1D Bracketing and matrixing designs for stability testing of drug substances and drug products
- ICH Q1E Evaluation of stability data
- ICH Q1F Stability data package for registration in climatic zones III and IV
- Declaration of storage conditions for medicinal products particulars and active substances (Annex)
- In-use stability testing of human medicinal products
- Maximum shelf-life for sterile products for human use after first opening or following reconstitution
- Start of shelf-life of the finished dosage form (Annex to the note for guidance on the manufacture of the finished dosage form)
- Stability testing for applications for variations to marketing authorisation
- Stability testing of existing active ingredients and related finished products