Regulations for Registration of Medicinal Products Article 10
The testing specifications, methods and certificate of analysis of finished products mentioned in this Chapter refer to those performed on pharmaceutical preparations.The regulations of testing specifications, methods and certificate of analysis of finished products said in the preceding paragraph are as follows:1.If the applied drugs are listed in pharmacopoeias, the testing specifications attached to the application form should include the pharmacopoeia’s titles, publication year and editions. Such reference is restricted to the Chinese Pharmacopoeia, pharmacopoeia published in the A10 countries or acknowledged by the central health competent authority in Taiwan. The cited edition should be the latest from the date of application. This requirement also applies to any post-approval change of finished products. The publication year has to be within 5 years from the date of application. If the item in the pharmacopoeia includes more than two esters or salts, or contains ingredients with crystallized water or anhydride, the applicants should clearly specify which one is applicable to this application. In vitro pyrogen test methods should be considered alternatives for animal tests.2.For each active ingredient, the applicant should state its standard test scopes and methods in the testing specifications. Denotation of the identification and assay of the contents should not be simply summarized as “operated according to certain pharmacopoeias”.3.If necessary, upon the request of the central health competent authority, the applicant should provide test records, including the information listed below and all test data to justify whether current regulations and criteria have been met:(1) Sampling venues, quantity, batch numbers or other specific codes, the date of sampling and the date when tests were completed;(2) References to justify every test method;(3) The weight or volume of samples for each test;(4) The reference standards for each test 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, content (potency), test specifications, certificate of analysis and calibration procedures should be specified;(5) Complete data records produced from each test, including equipment output charts and spectrums, etc. All data should be clearly described to avoid confusion;(6) All calculation records associated with tests;(7) Conclusions on the comparison between test results and existing specifications;(8) For every test, the names of the persons performing the test and the date of the test;(9) Signatures from reviewers who have checked the original records for accuracy, safety and the compliance with existing specifications.4.Provisions set out in Paragraph 2 Item 5 to Item 7 of the preceding article are applicable to the certificate of analysis of finished products.For toll-manufactured pharmaceutical products, the tests of finished products should comply with the Guidelines on Toll-Manufacturing and Contract Testing of Pharmaceutical Products. The purpose of those tests is to ensure drug quality. Tests can be performed by the commissioned toll-manufacturers.
中文原文 藥品查驗登記審查準則第10條
本章所稱成品檢驗規格、方法及檢驗成績書，係指藥品製劑之檢驗規格、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、申請查驗登記之藥品如屬藥典藥品者，應於申請書及所附檢驗規格中記明所依據藥典之名稱、年次及版次；其藥典並以中華藥典、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，其所依據藥典之檢驗項目、方法或規格有變更者，亦同。
於同一品名下有二種以上酯或鹽類、或含結晶水及無水物之成分者，均應明確記載申請案件係採用何種。
熱原試驗應以非活體動物替代方式優先。
二、申請查驗登記藥品之各有效成分，均應於檢驗規格中明確記載其各項合格範圍及檢驗方法；其鑑別及含量測定，不得僅記載按某藥典操作代之。
三、必要時，申請人應依中央衛生主管機關之要求，提出檢驗紀錄，包括所有為確定是否符合既訂規格及標準之檢驗所得數據與下列紀錄：
（一）樣品之取樣地點、數量、批號或其他明確之代號、取樣日期、樣品化驗完成日期。
（二）所有檢驗方法之依據。
（三）每一檢驗所用樣品之重量或容量。
（四）檢驗所需之標準品，應註明檢驗所需之標準品，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。
（五）每一檢驗過程中所產生數據之完整紀錄，包括儀器輸出之圖表及光譜等，均應明確標記，避免混淆。
（六）有關檢驗之所有運算紀錄。
（七）檢驗結果須與既訂規格相比較而作判定。
（八）每一檢驗操作者之姓名及日期。
（九）校核者簽名認定已檢視原始紀錄之精確性、安全性與符合既訂規格之記載。
四、成品檢驗成績書，準用前條第二項第五款至第七款之規定。
分段委託製造藥品成品檢驗試驗之執行，應符合藥物委託製造及檢驗作業準則之規定，並以能確認藥品之品質為原則，不限由分段委託製造製程之受託製造廠執行。
前項檢驗規格、方法及檢驗成績書，規定如下：
一、申請查驗登記之藥品如屬藥典藥品者，應於申請書及所附檢驗規格中記明所依據藥典之名稱、年次及版次；其藥典並以中華藥典、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，其所依據藥典之檢驗項目、方法或規格有變更者，亦同。
於同一品名下有二種以上酯或鹽類、或含結晶水及無水物之成分者，均應明確記載申請案件係採用何種。
熱原試驗應以非活體動物替代方式優先。
二、申請查驗登記藥品之各有效成分，均應於檢驗規格中明確記載其各項合格範圍及檢驗方法；其鑑別及含量測定，不得僅記載按某藥典操作代之。
三、必要時，申請人應依中央衛生主管機關之要求，提出檢驗紀錄，包括所有為確定是否符合既訂規格及標準之檢驗所得數據與下列紀錄：
（一）樣品之取樣地點、數量、批號或其他明確之代號、取樣日期、樣品化驗完成日期。
（二）所有檢驗方法之依據。
（三）每一檢驗所用樣品之重量或容量。
（四）檢驗所需之標準品，應註明檢驗所需之標準品，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。
（五）每一檢驗過程中所產生數據之完整紀錄，包括儀器輸出之圖表及光譜等，均應明確標記，避免混淆。
（六）有關檢驗之所有運算紀錄。
（七）檢驗結果須與既訂規格相比較而作判定。
（八）每一檢驗操作者之姓名及日期。
（九）校核者簽名認定已檢視原始紀錄之精確性、安全性與符合既訂規格之記載。
四、成品檢驗成績書，準用前條第二項第五款至第七款之規定。
分段委託製造藥品成品檢驗試驗之執行，應符合藥物委託製造及檢驗作業準則之規定，並以能確認藥品之品質為原則，不限由分段委託製造製程之受託製造廠執行。