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:
as regards personnel, premises and equipment, documentation, production, quality control, responsibilities of the qualified person, outsourced operations, complaints, product recall and emergency unblinding
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.