Quality: manufacturing
HumanRegulatory and procedural guidanceQuality of medicinesResearch and developmentScientific guidelines
The European Medicines Agency's scientific guidelines on the manufacture of medicinal 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 Q8 (R2) Pharmaceutical development
- ICH Q9 Quality risk management
- ICH Q10 Pharmaceutical quality system
- ICH Q8, Q9 and Q10 - questions and answers
- ICH guideline Q13 on continuous manufacturing of drug substances and drug products
- Manufacture of the finished dosage form
- Process validation for finished products – information and data to be provided in regulatory submissions - Scientific guideline
- Start of shelf-life of the finished dosage form (Annex to the note for guidance on the manufacture of the finished dosage form) - Scientific guideline
- Sterilisation of the medicinal product, active substance, excipient and primary container
- Use of ionizing radiation in the manufacture of medicinal products
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