Regulations for Registration of Medicinal Products Article 9
The testing specifications, methods and certificate of analysis of raw materials mentioned in this Chapter refer to those for active pharmaceutical ingredients (API) and every substance of the formula (including auxiliary materials and coloring agents added during the manufacturing process).The testing specifications, methods and certificate of analysis of raw materials said in the preceding paragraph should comply with the following regulations:1.If using a pharmacopoeia as a reference for raw materials, the applicant should indicate the pharmacopoeia’s titles, publication year and editions. The pharmacopoeia is restricted to the Chinese Pharmacopoeia, pharmacopoeias published by the A10 countries, or pharmacopoeias approved by the central health competent authority. The cited edition should be the latest from the date of application. This requirement also applies to any post-approval change of raw materials except excipients.2. New chemical entities (NCE) are subject to the regulations set by the manufacturers.3. The reference standards for tests should be indicated whether they are Primary Standard or Working Standard. For Primary Standard, the source should be specified. For Working Standard, the source, batch number, labelled content (or potency), testing specifications, certificate of analysis and calibration procedures should be specified.4. For coloring agents, testing specifications and methods should be indicated. Testing specifications are not required for aromatics.5. The certificate of analysis justifying every formulation substance should be the certificates about the substances of the same lot as the finished products.6. Raw materials should be tested against each specification item. Documented operational procedures of items exempted from tests should be submitted, along with the certificates of analysis of the batch subject to full tests.7. If test results are in numerical figures, then keep the original data in the document; if the test is a comparison with reference standard, then use “pass” to indicate a satisfactory result.
中文原文 藥品查驗登記審查準則第9條
本章所稱原料檢驗規格、方法及檢驗成績書，係指各有效成分原料及其每一處方成分原料（包括製程中加入輔助原料及色素）之檢驗規格與方法及檢驗成績書。
前項檢驗規格、方法及檢驗成績書，規定如下：
一、申請查驗登記藥品所用之原料，其依據藥典者，應依序註明藥典名稱、年次及版次。
但依據之藥典，以中華藥典、十大醫藥先進國家出版之藥典、或其他經中央衛生主管機關採用之藥典為限；其版本應為所採用者之最新版；取得藥品許可證後，除賦形劑外，其所依據藥典之檢驗項目、方法或規格有變更者，亦同。
二、新成分新藥得依廠規為主。
三、檢驗所需之標準品，應註明係PrimaryStandard或WorkingStandard。
如係PrimaryStandard者，應註明來源；如係WorkingStandard者，應註明來源、批號及標示含量（或力價）、檢驗規格、檢驗成績書、標定程序。
四、色素應有檢驗規格及方法；香料無需檢附檢驗規格。
五、每一處方成分原料之檢驗成績書，應為所附成品批次使用之原料檢驗成績書。
六、原料應依規格逐項檢驗，如有減免者，應檢附減免之書面作業程序及其他全項檢驗批號之檢驗成績書。
七、檢驗結果如為數值者，應以數據表示；檢驗方法為比對標準品者，得以「合格」表示。
前項檢驗規格、方法及檢驗成績書，規定如下：
一、申請查驗登記藥品所用之原料，其依據藥典者，應依序註明藥典名稱、年次及版次。
但依據之藥典，以中華藥典、十大醫藥先進國家出版之藥典、或其他經中央衛生主管機關採用之藥典為限；其版本應為所採用者之最新版；取得藥品許可證後，除賦形劑外，其所依據藥典之檢驗項目、方法或規格有變更者，亦同。
二、新成分新藥得依廠規為主。
三、檢驗所需之標準品，應註明係PrimaryStandard或WorkingStandard。
如係PrimaryStandard者，應註明來源；如係WorkingStandard者，應註明來源、批號及標示含量（或力價）、檢驗規格、檢驗成績書、標定程序。
四、色素應有檢驗規格及方法；香料無需檢附檢驗規格。
五、每一處方成分原料之檢驗成績書，應為所附成品批次使用之原料檢驗成績書。
六、原料應依規格逐項檢驗，如有減免者，應檢附減免之書面作業程序及其他全項檢驗批號之檢驗成績書。
七、檢驗結果如為數值者，應以數據表示；檢驗方法為比對標準品者，得以「合格」表示。