On 14-15 December 2021, CFDI attended the second PIC/S Expert Circle On Cross Contamination In Shared Facilities (CCCISF) Meeting hosted by WHO virtually.
The meeting focused and communicated on four topics: "PIC/S Inspection Aide-memoire and GMP's Control Requirements for Cross-Contamination in Shared Facilities", "Inspection Strategies", "Cleaning Validation" and "PDE Viewpoint – A Perspective on Toxicology". Inspection experts from US FDA, SAHPRA , AIFA, TFDA and other organizations introduced the importance of CCCISF Aide-memoire updates in directing GMP inspectors when assessing the potential risk of cross-contamination in shared facilities, PIC/S GMP Requirements for Contamination and Cross-Contamination, WHO GMP guidelines on hazardous substances and management and other related guidelines, CCCISF’s Perspective on inspection, case studies, a brief scenario description based on cleaning validation, the differentiation between good and poor PDE reports, and answered questions raised by the attendees.
Members from Office of the Leading Group for PIC/S Accession, NMPA and more than 30 inspectors from CFDI attended the meeting.