Pharmaceutical Good Manufacturing Practice Regulations Article 37
Chinese herbal medicine factories shall, in accordance with product type, content and dosage form, separately store and appropriately mark labels and other labeling materials; storage areas for aforesaid materials may not be entered without the consent of the personnel in charge.Packaging or labeling materials that have expired or are not approved for use shall be returned or destroyed. The amounts of labeling materials received, used and returned shall be kept track of, and no discrepancies shall be allowed.Unused portions of labeling materials printed with batch numbers shall be destroyed; unused labeling materials that are not printed with batch numbers shall be appropriately identified and stored.
中文原文 藥物優良製造準則第37條
中藥廠對於標籤及其他標示材料,應依產品之種類、含量及劑型,分別儲存,並予適當標識;其儲存區域,非經有關權責人員同意,不得進入。
過時或拒用之包裝材料及標示材料,應予退貨或銷毀。
標示材料之發放與使用及退回數量,應相符合。
印有批號之標示材料,如有剩餘應即銷毀;如有未印批號者,應予適當鑑識及儲存。
過時或拒用之包裝材料及標示材料,應予退貨或銷毀。
標示材料之發放與使用及退回數量,應相符合。
印有批號之標示材料,如有剩餘應即銷毀;如有未印批號者,應予適當鑑識及儲存。