Guidelines of Good Manufacture Practice (GMP)for Veterinary Drugs Manufacturers Article 42
The Manufacturer shall order the written treatment operating procedures for written or oral complaints from customers. The Quality Control Department shall exercise the examination and confirmation of all written or oral claims.Any apparently severe and unexpected product defect shall be reported to the respective relevant competent authorities and treated in compliance with the related provisions in the Veterinary Drugs Control Act.There shall be written records of the treatment of all complaints along with collation and filing as the references to the quality assessment of the product concerned.
中文原文 動物用藥品優良製造準則第42條
藥廠對於消費者提出之書面或口頭申訴,應以書面訂立處理作業程序;其品質管制部門應對所有書面或口頭申訴進行審查並予確認。
對於明顯嚴重且非預期之產品缺失,應即向各相關主管機關報告。
並依動物用藥品管理法相關規定處理。
所有申訴之處理,應留書面紀錄,並予整理建檔,供該產品品質評估作業之參考。
對於明顯嚴重且非預期之產品缺失,應即向各相關主管機關報告。
並依動物用藥品管理法相關規定處理。
所有申訴之處理,應留書面紀錄,並予整理建檔,供該產品品質評估作業之參考。