Guidelines of Good Manufacture Practice (GMP)for Veterinary Drugs Manufacturers Article 43
The returned product shall be examined and stored separately. The Manufacturer shall destroy the product if there is any doubt of the product safety, ingredients, strength / contents, quality or purity due to storage and transport conditions prior to the return or in the return process or the product, container, packaging, labeling or other situations where the safety, ingredients, strength / contents, quality or purity fails to conform to the existing specifications through inspection or investigation. The reprocessing may be conducted if the product can conform to the existing specifications through the reprocessing.
中文原文 動物用藥品優良製造準則第43條
藥廠對於退回之產品，應予鑑識並分別儲存。
藥廠如因退回前或退回過程之儲存、運送條件，或因產品、容器、包裝、標示或其他狀況，致對產品之安全性、成分、含量、品質或純度發生疑慮時，非經檢驗或調查確定其安全性、成分、含量、品質或純度符合既定之規格者，該產品應予銷毀。
但如經再製後能符合既定之規格者，得進行再製。
藥廠如因退回前或退回過程之儲存、運送條件，或因產品、容器、包裝、標示或其他狀況，致對產品之安全性、成分、含量、品質或純度發生疑慮時，非經檢驗或調查確定其安全性、成分、含量、品質或純度符合既定之規格者，該產品應予銷毀。
但如經再製後能符合既定之規格者，得進行再製。