Guidelines of Good Manufacture Practice (GMP)for Veterinary Drugs Manufacturers Article 35
The records relating to the manufacture, control and distribution shall be kept for at least 2 years after the expiry date of the batch of the product or finished product.The records or the copies concerned, prescribed in the Guidelines, shall be reserved in the proper place in the reserved period for random audits exercised by the competent authority at any time; the auditor may copy or duplicate the record or the copy concerned in any manner.The Manufacturer shall exercise the assessment of the product quality standards at least once annually to determine whether there is any improvement for the product standards and the manufacture or control operating procedures based on the records prescribed in Paragraph 1.
中文原文 動物用藥品優良製造準則第35條
本準則所定有關製造、管制及運銷之紀錄，均應至少保存至該批產品或最終產品有效期間後二年。
本準則所定之所有紀錄或其副本在保存期間，應存於適當場所，並隨時供主管機關稽查；稽查人員得影印或以其他方法複製該紀錄或其副本。
藥廠每年應至少辦理一次產品品質標準之評估，並以第一項紀錄為依據，以決定產品之規格、製造或管制作業程序是否需要改進。
本準則所定之所有紀錄或其副本在保存期間，應存於適當場所，並隨時供主管機關稽查；稽查人員得影印或以其他方法複製該紀錄或其副本。
藥廠每年應至少辦理一次產品品質標準之評估，並以第一項紀錄為依據，以決定產品之規格、製造或管制作業程序是否需要改進。