Pharmaceutical Good Manufacturing Practice Regulations Article 138
Manufacturers that manage the handling, storage, packaging, preservation and delivery of product shall comply with the following requirements:(1) Handling: Appropriate methods for handling product that prevent damage or deterioration shall be provided.(2) Storage: Designated storage areas or stock rooms shall be used to prevent damage or deterioration of product, pending use or delivery. Appropriate methods for authorizing receipt to and dispatch from such areas shall be stipulated. In order to detect deterioration, the condition of product in stock shall be assessed at appropriate intervals.(3) Packaging: Packing and marking processes (including materials used) shall be controlled to the extent necessary to ensure conformance to specified requirements.(4) Preservation: Appropriate methods for preservation and segregation of product shall be applied when the product is under the manufacturer’s control.(5) Delivery: Protection of the quality of product shall be arranged for after final inspection and test. Where contractually specified, this protection shall be extended to include delivery to destination.
中文原文 藥物優良製造準則第138條
製造業者處理產品之搬運、儲存、包裝、防護及交貨，應符合下列規定：
一、搬運：應有適當搬運產品方法，防止產品損傷或變質。
二、儲存：應使用指定之儲存場所或庫房，防止產品於待用或待運期中受損傷或變質，並規定管理進出儲存貨物之適切收發方法，且適時作定期評鑑，檢測庫存品變質狀況。
三、包裝：對包裝、裝箱及標識流程（含所用材料），應作必要管制，確保符合規定要求。
四、防護：應使用適當方法，防護、隔離管制下之產品。
五、交貨：於產品最終檢驗與測試後，應作適當安排以保護產品品質；如合約約定者，其產品保護並應延伸至包括交貨目的地在內。
一、搬運：應有適當搬運產品方法，防止產品損傷或變質。
二、儲存：應使用指定之儲存場所或庫房，防止產品於待用或待運期中受損傷或變質，並規定管理進出儲存貨物之適切收發方法，且適時作定期評鑑，檢測庫存品變質狀況。
三、包裝：對包裝、裝箱及標識流程（含所用材料），應作必要管制，確保符合規定要求。
四、防護：應使用適當方法，防護、隔離管制下之產品。
五、交貨：於產品最終檢驗與測試後，應作適當安排以保護產品品質；如合約約定者，其產品保護並應延伸至包括交貨目的地在內。