European Commission 23 May 2017, Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (Text with EEA relevance. )

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European Union · · · Cited by 34 · 23-05-2017

CHAPTER I. GENERAL PROVISIONS
Article 1. Subject matter
Article 2. Definitions
CHAPTER II. GOOD MANUFACTURING PRACTICE
Article 3. Conformity with good manufacturing practice
Article 4. Compliance with clinical trial authorisation
Article 5. Pharmaceutical quality system
Article 6. Personnel
Article 7. Premises and equipment
Article 8. Documentation
Article 9. Production
Article 10. Quality control
Article 11. Retention of samples used for quality control
Article 12. Responsibilities of the qualified person
Article 13. Outsourced operations
Article 14. Complaints, product recall and emergency unblinding
Article 15. Self-inspection by the manufacturer
Article 16. Advanced therapy investigational medicinal products
CHAPTER III. INSPECTIONS
Article 17. Supervision by inspection
Article 18. Cooperation and coordination of inspections
Article 19. Recognition of inspection conclusions
Article 20. Empowerments of the inspectors
Article 21. Competence and obligations of the inspectors
Article 22. Quality system
Article 23. Impartiality of inspectors
Article 24. Access to premises
Article 25. Suspension or revocation of manufacturing authorisation
CHAPTER IV. FINAL PROVISIONS
Article 26. Transitional provision
Article 27. Entry into force

16.9.2017

Official Journal of the European Union

L 238/12

COMMISSION DELEGATED REGULATION (EU) 2017/1569

of 23 May 2017

supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections

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