Quality guidelines: manufacturing
HumanRegulatory and procedural guidanceQuality of medicinesResearch and developmentScientific guidelines
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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
- Start of shelf-life of the finished dosage form (Annex to the note for guidance on the manufacture of the finished dosage form)
- Sterilisation of the medicinal product, active substance, excipient and primary container
- Use of ionizing radiation in the manufacture of medicinal products