Case Analysis and Reflection on Remote Inspection of Drug Production
Objective To provide a reference for drug regulatory authorities to carry out remote inspection of drug production.Methods The relevant systems and practical cases of remote inspection of domestic drug production were sorted out,the risk assessment and implementation of remote inspection-related cases from both enterprises and inspection institutions were analyzed,and the key points of remote inspection were summarized.Results and Conclusion Before the inspection,a thorough risk assessment should be conducted.During the inspection,attention should be paid to IT support,effective communication,and risk control.After the inspection,the right to conduct on-site inspections should be retained.
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维普
