Launch of a pilot Single Inspection Program, a global approach to GMP inspections of third country manufacturers.
Health Canada, the Therapeutic Goods Administration (TGA) and the Medicines & Healthcare products Regulatory Agency (MHRA), all members of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), International Coalition of Medicines Regulatory Authorities (ICMRA) and Access Consortium, have begun piloting a Good Manufacturing Practice (GMP) Single Inspection Program (SIP).
This pilot aims to establish a coordinated global approach to GMP inspections of foreign manufacturing sites of common interest. Using our collective inspection resources, each authority has agreed to cover the scope of the other where possible, reducing the need for multiple inspections of the same site.
This builds on the success of our existing collaborative GMP arrangements and will allow for more efficient inspection reliance processes, reduced regulatory burden on industry and enhanced collaboration in our regulatory oversight of common global supply chains.
Leave a comment