Objective To identify and reduce the gap between China’s drug GMP inspection and pharmaceutical inspection co-operation scheme(PIC/S)audit checklist,find out the key improvement items,and revise them pertinently,whic...Objective To identify and reduce the gap between China’s drug GMP inspection and pharmaceutical inspection co-operation scheme(PIC/S)audit checklist,find out the key improvement items,and revise them pertinently,which will promote the process of China joining PIC/S.Methods The general situation of PIC/S organization and audit checklist were introduced first,and then the accession of several countries that joined the organization was analyzed.Meanwhile,the process of China’s participation in PIC/S was sorted out.After referring to the contents of PIC/S audit checklist,the problems of GMP inspection system in China were studied.Results and Conclusion There are still many problems in GMP inspection in China.Some suggestions are put forward for improvement and change,which can provide reference for the development of drug inspection agencies at all levels in China.展开更多
Objective To introduce the accession procedure and evaluation of PIC/S,and help relevant departments in China to understand the requirements of PIC/S in detail,and to promote the process of China’s entry into PIC/S.M...Objective To introduce the accession procedure and evaluation of PIC/S,and help relevant departments in China to understand the requirements of PIC/S in detail,and to promote the process of China’s entry into PIC/S.Methods The procedures and steps of joining PIC/S,the evaluation process of PIC/S,and the experience of several countries in joining PIC/S were introduced and analyzed,which could help the relevant personnel in China understand the specific contents.Results and Conclusion According to the requirements of PIC/S,it is necessary to establish a unified GMP quality management system.展开更多
文摘Objective To identify and reduce the gap between China’s drug GMP inspection and pharmaceutical inspection co-operation scheme(PIC/S)audit checklist,find out the key improvement items,and revise them pertinently,which will promote the process of China joining PIC/S.Methods The general situation of PIC/S organization and audit checklist were introduced first,and then the accession of several countries that joined the organization was analyzed.Meanwhile,the process of China’s participation in PIC/S was sorted out.After referring to the contents of PIC/S audit checklist,the problems of GMP inspection system in China were studied.Results and Conclusion There are still many problems in GMP inspection in China.Some suggestions are put forward for improvement and change,which can provide reference for the development of drug inspection agencies at all levels in China.
文摘Objective To introduce the accession procedure and evaluation of PIC/S,and help relevant departments in China to understand the requirements of PIC/S in detail,and to promote the process of China’s entry into PIC/S.Methods The procedures and steps of joining PIC/S,the evaluation process of PIC/S,and the experience of several countries in joining PIC/S were introduced and analyzed,which could help the relevant personnel in China understand the specific contents.Results and Conclusion According to the requirements of PIC/S,it is necessary to establish a unified GMP quality management system.
