【正文】 stest35341,57251inprocedurefortestwhatanalytical procedure shouldofTherefer to “testThe本文件敘述的幾種方法的驗證需要考慮的典型的分析性能參數(shù)列在表1中。VALIDATION驗證Validation of an analytical procedure is the process by which it is established, by laboratory studies, that the performance characteristics of the procedure meet the requirements for the intended analytical applications. Typical analytical performance characteristics that should be considered in the validation of the types of procedures described in this document are listed in需要包括對于證明每一個實用功能特性的實驗數(shù)據(jù)和計算的概況、總結(jié)。應(yīng)包括所有的重要的操作參數(shù)和具體的操作，如試劑的制備，系統(tǒng)適應(yīng)性性能的測試，空白溶液使用的敘述，注意事項，和用于計算檢測結(jié)果的明確的公式。對于已修改的方法，需比較當(dāng)前方法的局限性和擬定方法的優(yōu)點。涉及方法的類別改變，資料可能也會改變。SUBMISSIONS TO THE COMPENDIA遞交至藥典Submissions to the pendia for new or revised analytical procedures should contain sufficient information to enable members of the USP Council of Experts and its Expert Committees to evaluate the relative merit of proposed procedures. In most cases, evaluations involve assessment of the clarity and pleteness of the description of the analytical procedures, determination of the need for the procedures, and documentation that they have been appropriately validated. Information may vary depending upon the type of method involved. However, in most cases a submission will consist of the following sections.將新的或修改后的分析方法遞交至藥典，應(yīng)包含足夠的資料從而使得USP委員會專家和其專家委員會能夠評估擬定方法的價值。MethodologyValidation of Analytical Procedures考慮到USP和NF的法律地位，采用新的或修改后的藥典分析方法的建議，并且這個建議是由充分的實驗室數(shù)據(jù)支持以證明其有效，這是十分必要的。CGMP法規(guī)[21 CFR (a)]要求：用于評估藥品滿足已建立的規(guī)范的檢驗方法必須滿足準確、可靠、適當(dāng)?shù)臉藴?。standards, it is essential, therefore, that proposals for adoption of new or revised pendial analytical procedures be supported by sufficient laboratory data to document their validity.用于評估藥品質(zhì)量的檢驗方法需要滿足不同的要求。USP andUSP–NFVALIDATION OF COMPENDIAL PROCEDURES藥典方法的驗證Test procedures for assessment of the quality levels of pharmaceutical articles are subject to various requirements. According to Section 501 of the Federal Food, Drug, and Cosmetic Act, assays and specifications in monographs of the United States Pharmacopeia and the National Formulary constitute legal standards. The Current Good Manufacturing Practice regulations [21 CFR (a)] require that test methods, which are used for assessing pliance of pharmaceutical articles with established specifications, must meet proper standards of accuracy and reliability. Also, according to these regulations [21 CFR (a)(2)], users of analytical methods described inare not required to validate the accuracy and reliability of these methods, but merely verify their suitability under actual conditions of use. Recognizing the legal status ofNF根據(jù)聯(lián)邦食品，藥品，和化妝品法案501章，美國藥典和國家處方專題論文里的試驗和規(guī)范構(gòu)成了法律標準。此外，根據(jù)法規(guī)21 CFR (a)(2)，USPNF中敘述的分析方法的使用者不需要驗證這些方法的準確度和可信度，僅僅需要確認在實際使用條件下的適用性。The text of this information chapter harmonizes, to the extent possible, with the Tripartite International Conference on Harmonization (ICH) documentsand theextension text, which are concerned with analytical procedures included as part of registration applications submitted within the EC, Japan, and the USA.這一章節(jié)的內(nèi)容盡可能地和ICH文獻“分析方法的驗證和方法學(xué)”（文獻與包含在EC，日本和美國遞交的注冊申請中的分析方法相關(guān)）協(xié)調(diào)一致。絕大多數(shù)情況下，評估包括透明度的評估和分析方法敘述完整性的評估，確定方法需求，以及專家已經(jīng)充分驗證的文件。然而，大部分情況下，遞交應(yīng)包含如下的章節(jié)Rationale—This section should identify the need for the procedure and describe the capability of the specific procedure proposed and why it is preferred over other types of determinations. For revised procedures, a parison s