USP〈1225〉药典规程的验证(中英文对照)(2)

SUBMISSIONS TO THE COMPENDIA向药典提交的文件

Submissions to the compendia 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 completeness 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.

向药典提交关于新的或更改过的分析规程的文件应该包括充足的信息，以使USP专家大会和其专家委员会能够评估拟议规程的相对优势。在大多数情况下，这些评估涉及对分析规程描述的清楚和完整程度的评价，对规程的需求的确定，以及它们已经进行了适当验证的记录文件。这些信息可以根据所涉及规程的种类而变化。但是，在大多数情况下，提交的文件将有下面的章节组成。

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 comparison should be provided of limitations of the current compendial procedure and advantages offered by the proposed procedure.

基本原理---- 此部分应该辨明对于该规程的需求，并描述具体拟议中规程的能力，以及其为什么优于其他种类检测。对于更改的规程，应该提供对当前药典规程之缺陷与拟议中规程之优势的比较。

Proposed Analytical Procedure--- This section should contain a complete description of the analytical procedure sufficiently detailed to enable persons “skilled in the art” to replicate it. The write-up 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.

拟议的分析规程---- 此部分包含对该分析规程的完整描述，应足够具体以便能让业内技术熟练

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