New PIC/S guidance on GMP inspection reliance based on draft by ICMRA with aim to maximise inspection resources for GMP compliance of overseas facilit
New PIC/S guidance on GMP inspection reliance based on draft by ICMRA with aim to maximise inspection resources for GMP compliance of overseas facilities
Geneva, 14 June 2017: PIC/S has adopted a new guidance on GMP inspection reliance (PI 048-1), which entered into force on 1 June 2018.
This guidance provides a tool and framework which aims to help Competent Authorities (CA) prioritise resources for GMP inspections for human and veterinary medicines. The main feature of the guidance is that it outlines a process for desk-top assessment of GMP compliance of overseas facilities to identify instances where an acceptable level of GMP compliance can be confirmed and assured from the activities of another CA or CAs without the need for an on-site inspection.
The guidance is based on a draft by the International Coalition of Medicines Regulatory Authorities (ICMRA) GMP Inspection Reliance Framework. It is a non-binding (i.e. applicable on a voluntary basis) high-level guidance for ICMRA and PIC/S Participating Authorities (PA) alike.
For more information see the PIC/S Newsletter of May 2018
To download the guidance, please consult the page “Publications” or click on the link below: