Pharmaceutical Good Manufacturing Practice Regulations Article 106
Manufacturers shall identify the product by suitable means throughout product realization, and shall establish documented procedures for such product identification.Manufacturers shall establish documented procedures to ensure that medical devices returned to the manufacturers are identified and distinguished from conforming product.
中文原文 藥物優良製造準則第106條
製造業者應於整個產品實現過程，以適當方法識別產品，並建立書面之產品識別程序。
製造業者應建立書面程序，以確保識別退回之醫療器材，且能與合格產品區隔。
製造業者應建立書面程序，以確保識別退回之醫療器材，且能與合格產品區隔。