Pharmaceutical Good Manufacturing Practice Regulations Article 136
Manufacturers shall establish and maintain documented procedures to ensure that product that does not conform to specified requirements is prevented from unintended use or installation.The above control shall provide for identification, documentation, evaluation, segregating (when practical), disposition of nonconforming product, and for notification to the functions concerned.
中文原文 藥物優良製造準則第136條
製造業者應建立並維持書面程序，管制不合格品免於被誤用或安裝。
前項管制應提供不合格品之識別、文書處理、評估、隔離（如可行時）、處置及對有關權責單位之通知。
前項管制應提供不合格品之識別、文書處理、評估、隔離（如可行時）、處置及對有關權責單位之通知。