Pharmaceutical Good Manufacturing Practice Regulations Article 109
Manufacturers shall identify the product status with respect to monitoring and measurement requirements.Manufacturers shall maintain the identification of product status throughout production, storage, installation and servicing of the product to ensure that only product that has passed the required inspections and tests, or released under an authorized concession, is dispatched, used or installed.
中文原文 藥物優良製造準則第109條
製造業者應根據監管與量測要求，鑑別產品狀態。
製造業者應於產品之生產、儲存、安裝及服務流程，維持產品狀態之鑑別，以確保僅通過所要求之檢查與測試，或經特准後放行之產品，始得放行、使用或安裝。
製造業者應於產品之生產、儲存、安裝及服務流程，維持產品狀態之鑑別，以確保僅通過所要求之檢查與測試，或經特准後放行之產品，始得放行、使用或安裝。