Regulations for the Inspection and Examination of Imported Medicaments Article 4
In addition to documentation review (as prescribed in Article 3), inspection authority can carry out the inspection of drugs in one or some of the following measures:1. Batch-by-batch examination: carried out for each submitted batch of drugs.2. Randomly-selected batch examination: performed based on a 2%-50% inspection rate.3. On-site inspection: inspecting and checking (hereinafter referred to as ‘verification’) of items, packaging, appearance and labels of products on site.
中文原文 輸入藥物邊境抽查檢驗辦法第4條
查驗機關對輸入之藥品實施查驗，除審核前條規定應檢具之文件外，並得就下列方式擇一或合併為之：
一、逐批檢驗：對各批次輸入藥品均予檢驗。
二、抽批檢驗：按百分之二至百分之五十之抽查率為之。
三、現場查核：於產品之堆置地點執行品目核對、包裝外觀及標示項目之檢查。
一、逐批檢驗：對各批次輸入藥品均予檢驗。
二、抽批檢驗：按百分之二至百分之五十之抽查率為之。
三、現場查核：於產品之堆置地點執行品目核對、包裝外觀及標示項目之檢查。