Regulations of the Lot Release Procedures for Biologics Article 4
Upon receiving application for lot release, the central competent health authority shall dispatch an agent to check if temperature for transportation and storage of biologics complies with requirements, and shall sample appropriate amount of biologics for inspecting and sampling; The remainder of biologics shall be sealed and kept by the pharmaceutical firms.
中文原文 生物藥品檢驗封緘作業辦法第4條
中央衛生主管機關受理檢驗封緘申請後，經派員查核生物藥品運送及貯存之溫度符合貯藏條件者，即抽取適量生物藥品供檢驗或留樣所需；剩餘生物藥品則應予封存，並交由藥商自行保管。