【正文】 VALIDATION OF COMPENDIAL PROCEDURES藥典方法的驗(yàn)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 inUSP–NFare 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 ofUSP andNFstandards, 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(píng)估藥品質(zhì)量的檢驗(yàn)方法需要滿足不同的要求。根據(jù)聯(lián)邦食品，藥品，和化妝品法案501章，美國(guó)藥典和國(guó)家處方專題論文里的試驗(yàn)和規(guī)范構(gòu)成了法律標(biāo)準(zhǔn)。CGMP法規(guī)[21 CFR (a)]要求：用于評(píng)估藥品滿足已建立的規(guī)范的檢驗(yàn)方法必須滿足準(zhǔn)確、可靠、適當(dāng)?shù)臉?biāo)準(zhǔn)。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(yàn)證這些方法的準(zhǔn)確度和可信度，僅僅需要確認(rèn)在實(shí)際使用條件下的適用性。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(gè)建議是由充分的實(shí)驗(yàn)室數(shù)據(jù)支持以證明其有效，這是十分必要的。The text of this information chapter harmonizes, to the extent possible, with the Tripartite International Conference on Harmonization (ICH) documentsValidation of Analytical Proceduresand theMethodologyextension 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(xiàn)“分析方法的驗(yàn)證和方法學(xué)”（文獻(xiàn)與包含在EC，日本和美國(guó)遞交的注冊(cè)申請(qǐng)中的分析方法相關(guān)）協(xié)調(diào)一致。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(huì)專家和其專家委員會(huì)能夠評(píng)估擬定方法的價(jià)值。絕大多數(shù)情況下，評(píng)估包括透明度的評(píng)估和分析方法敘述完整性的評(píng)估，確定方法需求，以及專家已經(jīng)充分驗(yàn)證的文件。涉及方法的類別改變，資料可能也會(huì)改變。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 should be provided of limitations of the current pendial procedure and advantages offered by the proposed procedure.基本原理—此章節(jié)應(yīng)確定方法的需求和敘述擬定的具體的方法的能力以及它優(yōu)于其它類別測(cè)定方法的原因。對(duì)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(diǎn)。Proposed Analytical Procedure—This section should contain a plete description of the analytical procedure sufficiently detailed to enable persons “skilled in the art” to replicate it. The writeup should include all important operational parameters and specific instructions such as preparation of reagents, performance of system suitability tests, description of blanks used, precautions, and explicit formulas for calculation of test results.擬定的分析方法—此章節(jié)應(yīng)包含詳細(xì)完整的分析方法的敘述，使得技術(shù)人員能夠重現(xiàn)。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(cè)試，空白溶液使用的敘述，注意事項(xiàng)，和用于計(jì)算檢測(cè)結(jié)果的明確的公式。Data Elements—This section should provide thorough and plete documentation of the validation of the ana