Pharmaceutical Good Manufacturing Practice Regulations Article 133
Manufacturers shall establish and maintain records which provide evidence that the product has been inspected and/or tested.The above records shall include the following:(1) Showing clearly whether the product has passed or failed the inspections or tests according to defined acceptance criteria. Where the product fails to pass any inspection or test, the procedures for control of nonconforming product shall apply;(2) Identifying the inspection authority responsible for the release of product.
中文原文 藥物優良製造準則第133條
製造業者應建立並保存紀錄，作為產品已完成檢驗、測試之證明。
前項紀錄應包括下列事項：
一、明確顯示產品是否依允收標準通過，或未通過檢驗或測試。
如產品未通過檢驗或測試，應依不合格品之管制程序處理。
二、紀錄上應能鑑別對產品放行之檢驗權責人員。
前項紀錄應包括下列事項：
一、明確顯示產品是否依允收標準通過，或未通過檢驗或測試。
如產品未通過檢驗或測試，應依不合格品之管制程序處理。
二、紀錄上應能鑑別對產品放行之檢驗權責人員。