Pharmaceutical Good Manufacturing Practice Regulations Article 28
The samples referred to in the preceding Article shall be tested in accordance with the following principles:(1) Every raw material shall be tested to determine whether it is in compliance with documented specifications. However, aside from identification tests, other tests may be waived if the test reports provided by the supplier are evaluated and found to be reliable.(2) Products containers and caps shall be tested to determine whether they are in compliance with established specifications.(3) Where raw materials, product containers or caps are susceptible to contamination by filth, insects, foreign objects or microorganisms, thus affecting their intended uses, relevant test items and methods shall be included in the quality specifications for aforesaid items, and each batch shall be inspected for contamination.
中文原文 藥物優良製造準則第28條
前條樣品，應依下列原則檢驗之：
一、每一原料應予檢驗，確定其符合書面規格。
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，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、每一原料應予檢驗，確定其符合書面規格。
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，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。