Also consider the extent of reliance placed on related analytical procedures.
同时,要考虑依赖有关分析程序的程度。
All analytical procedures are of equal importance from a validation perspective.
从验证的角度来看,所有的分析方法有着同样的重要性。
The principles, analytical procedures and calculation of the method were introduced.
介绍了该方法的原理、分析步骤及计算方法。
Failure to provide sufficient detail or use of unacceptable analytical procedures. For example.
未能提供分析方法的详细描述,或使用和了不可接受的分析方法。比如。
A detailed description of the analytical procedures used to characterize the reference standard.
用于界定标准品的分析程序的详细叙述。
The individual substances thus separated can be identified or determined by analytical procedures.
由此分开的这些单个物质可以通过分析过程鉴别或测定。
The review chemist evaluates the analytical procedures and validation data submitted in the NDA or ANDA.
审评化学家会对NDA或ANDA中的分析方法和验证资料进行评审。
The FDA laboratory analysis demonstrates that the analytical procedures are reproducible by laboratory testing.
FDA实验室的分析会论证该分析方法在实验室内是可以重现的。
Risk-oriented auditing emphasizes audit strategy, makes use of audit risk model and adopts analytical procedures.
它强调审计战略,使用审计风险模型,并积极采用分析性程序。
Methods validation is the process of demonstrating that analytical procedures are suitable for their intended use.
分析方法验证是论证某一分析方法适用于其用途的过程。
Information on the analytical procedures used to generate the data and validation of these procedures should be included.
用于产生数据的分析方法的信息以及这些方法的验证应包含在内。
They consist of tests of details of transactions classes, account balances and disclosures, and substantive analytical procedures.
实质性程序包括对各类交易、账户余额、披露的细节测试以及实质性分析程序。
Analytical validation information, including experimental data for the analytical procedures used for testing the drug substance, should be provided.
应提供分析验证信息,包括用于检测原料药的分析方法的实验数据。
In general, validated analytical procedures should be used, irrespective of whether they are for in-process, release, acceptance, or stability testing.
一般来说,应当要应用已验证过的分析方法,而不论其是被用于过程控制,放行,合格或稳定性实验。
For many analytical procedures intermediate precisionis typically assessed by determination of contributions to variance and, possibly, by a comparison of means.
对于很多分析方法,中间精密度通常通过确定偏差来源进行评估,通过比较分析的方式。
Examining degradation products under stress conditions is useful in establishing degradation pathways and developing and validating suitable analytical procedures.
强力破坏试验条件下检验降解产品对建立降解路径和开发、验证合适分析方法是有用的。
A list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described.
规范规范由一系列的试验、有关分析方法和认可标准组成,这些标准以限度值、范围或其他描述来表示。
Significant side products and impurities, particularly those that interfere with the analytical procedures or are toxic, should be illustrated separately see sections II.
重要的副产品和杂质,尤其是那些干扰分析过程或有毒性的,应当被分别表示出来参见:第ii。
The methods validation process for analytical procedures begins with the planned and systematic collection by the applicant of the validation data to support the analytical procedures.
分析方法的验证过程是从申请者有计划地系统性收集验证资料以支持分析方法开始的。
Analytical procedures used to Draft — Not for Implementation characterize a reference standard should not rely solely on comparison testing to a previously designated reference standard.
用于标准品界定的分析方法不应仅仅是和先前的指定标准品进行比较实验。
Field test calculation and analysis revealed that calculation results were accurate, testing technologies and analytical procedures were simple and it was suitable for field application.
通过现场测试计算和分析表明,该方法的计算结果正确、测试工艺及其分析过程简单,便于现场应用。
Analytical Style: Financial Manager (or programmers, engineers, and accountants). They like systems and procedures.
分析型:财务经理(或者程序员,工程师或者会计)他们喜欢系统和程序。
Fundamentals of analytical Chemistry are usually presented as a sum of chemical and physical foundations, laws, axioms and equations for analytical methods and procedures.
分析化学的基本规律通常被作为一笔化学制品和物理基础提出,分析的方法和程序的法律,公理和方程序。
The index system of safety evaluation is identified; the method and procedures of safety evaluation by applying the gray analytical hierarchy process are proposed.
笔者确定了电厂安全性评价的指标体系,提出了应用灰色层次分析法评价电厂安全性的方法与步骤。
The standard material of calf's liver(NBS-1577) is analysed by above procedures too and the analytical results were compared with reference values of the standard material.
并随同试样分析了美国标准局1577-小牛肝标准物,由标准物的测定值与其真值的偏离即能反映试样测定值与真值的差离程度。
The standard material of calf's liver(NBS-1577) is analysed by above procedures too and the analytical results were compared with reference values of the standard material.
并随同试样分析了美国标准局1577-小牛肝标准物,由标准物的测定值与其真值的偏离即能反映试样测定值与真值的差离程度。
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