Introduction and Enlightenment of GMP Inspection Reliance in PIC/S

OBJECTIVE To provide inspiration for our regulatory authority and drug manufacturers in international GMP inspection and mutual recognition through the introduction of PIC/S and GMP inspection reliance. METHODS Combined with the guidance of GMP inspection reliance, the introduction and assessment of an onsite inspection GMP of a manufacturing facility in an overseas territory in not required from the scope, process, monitoring and review. RESULTS Due to the implementation of GMP inspection reliance, it was not only help to integrate global inspection resources, but also reduced duplication of work and cost of regulatory authorities or manufacturers. CONCLUSION There are many benefits for them to apply for PIC/S membership and participate in mutual recognition in certain aspects, such as sharing information, establishing a professional inspection team, improving GMP standards and international influence.