The Analysis on PIC/S Technical Standards and Guidelines System
The National Medical Products Administration(NMPA)submitted application to the Pharmaceutical Inspection Cooperation Program(PIC/S)officially in September 2023 and has become an official applicant.Nowadays,PIC/S published a large number of tech-nical standards and guidelines for pharmaceutical regulatory agencies and industry.It would be helpful to drug regulatory agencies and the pharmaceutical industry become more effective to promote and respond to the application by familiarity and mastery these technical stand-ards and guidelines.The study analyzes these technical standards and guidelines published by PIC/S according to the classification of GMP guides,inspectorates guidelines,guidance documents,aide-memoires and other documents.Based on the research on system level,it provides a reference for relevant units and individuals have a better understanding of PIC/S standard and guidance system.
Drug inspectionPharmaceutical Inspection Cooperation Program(PIC/S)Good Manufacturing Practice(GMP)
国家科技期刊平台
NSTL
万方数据
