新冠肺炎疫情（COVID-19）下之藥廠GMP管理因應措施研析──遠距查核   全文下載

A Study on Mitigation Strategies for Pharmaceutical Manufacturers GMP Compliance Assessment Under Covid-19 Pandemic-remote Inspection

值新冠肺炎疫情（COVID-19）的影響下，2020年初起各國陸續於國內外實施旅遊限制、城市封鎖，以及邊境管制等政策，而各國對於國內外藥品製造廠的實地查核也因而暫緩。然而，為維護民眾用藥權益，降低缺藥風險，並確保用藥之安全、品質及有效性，各國衛生主管機關亦陸續發布藥廠GMP管理因應措施。多數主管機關改以書面審查或遠距查核作為無法實地查核時之替代措施。本研究分析各國對於遠距查核（remote inspection）及遠端評估（distant assessment）等名詞定義，並綜整各國官方與相關國際產業協會組織所發布之指引文件與資料，比較各國GMP管理之因應措施，並探討遠距查核之施行方式與執行時考量要點。對於多數國家而言，此法雖為疫情下可行的因應措施，現階段卻仍無法取代實地查核成為常態，即便接受過遠距查核者，仍需於恢復實地查核時成為優先查核的對象，對於國外藥廠管理而言更是如此。而食藥署亦將持續收集各國執行遠距查核之經驗並視疫情發展與風險的考量，來審慎評估我國國外藥廠GMP實地查核之因應措施。

Under the COVID-19 pandemic, in early 2020, countries worldwide began to impose travel restrictions and borders control, some even took lockdown measures, leading to the postpone of onsite inspections of pharmaceutical factories by regulatory authorities. Nevertheless, in order to protect the right of the public, reduce the risk of drug shortage and ensure the safety, quality and efficacy of medicinal products, many regulatory authorities have taken mitigation strategies for GMP compliance regulation. Most regulatory authorities conduct paper review or remote inspection. This article analyzes the definitions of terminologies related to ''remote inspection'' and ''distant assessment,'' and reviews guidance, documents and information released by regulatory authorities and international organizations, as well as explores the actual steps and requirements on conducting remote inspections. For most regulatory authorities, although the remote inspection seems to be a good mitigation strategy, it does not replace on-site inspection to be the new norm. Sites being inspected remotely will still be prioritized for on-site inspection once the pandemic is under control, especially for foreign manufacturers. Taiwan Food and Drug Administration (TFDA) will continue to collect information on remote inspection from all regulatory authorities as well as consider the development of the pandemic and risk to further evaluate the adaption of mitigation strategies for GMP compliance assessment.