Guidelines of Good Manufacture Practice (GMP)for Veterinary Drugs Manufacturers Article 30
The Manufacture shall set up the written responsibility and operating procedures for the Quality Control Department and include the circumstances as follows:1. In charge of the acceptance and the rejection of all raw materials, product containers, seals, in process products or intermediate products, packaging materials, labeling materials and products along with the examination of the manufacture records to ensure no occurrence of any errors or the thorough investigation of the errors;2. In charge of the examination of any operating procedures or specifications sufficient to affect the product ingredients, strength /contents, quality and purity;3. There shall be sufficient testing equipments to test and examine raw materials, product containers, seals, packaging materials, in process products, intermediate products or products;4. The institution of the written operating procedures of the calibration of the instruments, devices, meters and recorders along with the clear prescription of the calibration methods, timetables and limits of precision, and the limited use and supplemented measures if inconformity to the precision occurs;5. The institution of the written operating procedures of the sampling quantity, test interval, and test methods relating to the product stability meeting the storage conditions in the retail market to determine the proper expiration.
中文原文 動物用藥品優良製造準則第30條
藥廠應以書面訂立品質管制部門之職責及作業程序，並包括下列事項：
一、負責審核所有原料、產品容器、封蓋、半製品或中間產品、包裝材料、標示材料及產品之准用或拒用。
並得審查製造紀錄，確定並無任何錯誤發生，或錯誤發生情形業經徹底調查。
二、負責審核足以影響產品成分、含量、品質及純度之作業程序或規格。
三、應有足夠之檢驗設施，供檢驗及審核原料、產品容器、封蓋、包裝材料、半製品、中間產品或產品。
四、訂立有關儀器、裝置、儀表及記錄器之校正書面作業程序，明確規定校正方法、日程表、精確度界限，以及未能符合精確度界限時之限制使用及補救措施。
五、配合市售儲存條件訂立與產品安定性試驗有關之取樣數量、試驗間隔、試驗方法等之書面作業程序，決定適當之有效期間。
一、負責審核所有原料、產品容器、封蓋、半製品或中間產品、包裝材料、標示材料及產品之准用或拒用。
並得審查製造紀錄，確定並無任何錯誤發生，或錯誤發生情形業經徹底調查。
二、負責審核足以影響產品成分、含量、品質及純度之作業程序或規格。
三、應有足夠之檢驗設施，供檢驗及審核原料、產品容器、封蓋、包裝材料、半製品、中間產品或產品。
四、訂立有關儀器、裝置、儀表及記錄器之校正書面作業程序，明確規定校正方法、日程表、精確度界限，以及未能符合精確度界限時之限制使用及補救措施。
五、配合市售儲存條件訂立與產品安定性試驗有關之取樣數量、試驗間隔、試驗方法等之書面作業程序，決定適當之有效期間。