Guidelines of Good Manufacture Practice (GMP)for Veterinary Drugs Manufacturers Article 10
The sample prescribed in the preceding Article shall be tested in compliance with the principles prescribed below:1. Each raw material shall be tested to ensure the essence, purity and strength / contents to conform to meet the specifications. However,except for the identification test, the test may be exempted by assessing the reliability of the test report offered by the supplier;2. The product containers and seals shall be tested to ensure the conformity to the existing specifications;3. As for raw materials and product containers or seals vulnerable to the pollutants, insects, foreign matters or microbes leading to the impact on the expected purposes, there shall be tested items and methods in the quality specifications for the batch-by-batch test.
中文原文 動物用藥品優良製造準則第10條
前條樣品應依下列原則檢驗之：
一、每一原料均應予檢驗，確定其本質、純度及含量等均符合書面規格。
但除鑑別試驗外，得視供應商所提供檢驗報告之可靠性為評估後，酌予減免。
二、產品容器及封蓋應予檢驗，以確定其符合既定規格。
三、原料、產品容器或封蓋如易遭污物、昆蟲、外來異物或微生物污染致影響其預定用途者，應於品質規格中明訂其檢驗項目及方法，逐批檢查污染情形。
一、每一原料均應予檢驗，確定其本質、純度及含量等均符合書面規格。
但除鑑別試驗外，得視供應商所提供檢驗報告之可靠性為評估後，酌予減免。
二、產品容器及封蓋應予檢驗，以確定其符合既定規格。
三、原料、產品容器或封蓋如易遭污物、昆蟲、外來異物或微生物污染致影響其預定用途者，應於品質規格中明訂其檢驗項目及方法，逐批檢查污染情形。