Draft Commission Delegated Regulation supplementing Regulation (EU) No 536/2014 of the European Parliament and Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (16 pages + Annex 3 pages, in English)
This draft Delegated Regulation laying down principles and guidelines of good manufacturing practice for investigational medicinal products for human use and arrangements for inspections, provides for, inter alia:
• Requirements
as regards personnel, premises and equipment, documentation, production, quality control, responsibilities of the qualified person, outsourced operations, complaints, product recall and emergency unblinding
• Inspection
arrangements, e.g. unannounced inspections, requirement to draft an inspection report, granting of GMP certificates and submission to the Eudra GMDP of such certificates and mutual recognition of inspection conclusions
• Rules on conflict of interest and impartiality for GMP inspectors
• Inspectors' empowerment and competence.