This chapter uses various terms, acronyms, and activities common to analytical laboratories and validation disciplines. These terms and activities may not be identical to their usages in all laboratories. The reader is encouraged to be flexible in interpreting the application of these terms and activit...
This chapter uses various terms, acronyms, and activities common to analytical laboratories and validation disciplines. These terms and activities may not be identical to their usages in all laboratories. The reader is encouraged to be flexible in interpreting the application of these terms and activit...
22、haracteristics suggested in Chapter 1225. For these procedures the user is referred to the individual compendial chapter for those specific analytical validation characteristics and any specific validation requirements.Analytical Performance Characteristics accuracy Definition The accuracy of an ana 23、...
Chapter 1225 is intended to provide information that is appropriate to validate a wide range of compendial analytical procedures. The validation of compendial procedures may use some or all of the suggested typical analytical characteristics used in method validation as outlined in Table 1 and ...
The other three components of building quality into analytical data - analytical method validation, system suitability tests, and quality control check samples - are not within 21、the scope of this chapter. 下面的章节具体解答了AIQ的过程。确保分析数据质量的其他3个组成部分,分析方法验证、系统适用性...
The other three components of building quality into analytical data --—-- analytical method validation, system suitability tests, and quality control check samples -—-—- are not within the scope of this chapter。 下面的章节具体解答了AIQ的过程。确保分析数据质量的其他3个组成部分,分析方法验证、...
Such alternative procedures and methods shall be validated as described in the general chapter Validation of Compendial Procedures 1225 and must be shown to give equivalent or better results. Only those results obtained by the methods and procedures given in t...
ValidationversusQualification验证对确认 Inthischapter,thetermvalidationisusedformanufacturingprocesses,analyticalprocedures, andsoftwareproceduresandthetermqualificationisusedforinstruments.Thus,thephrase “analyticalinstrumentqualification”(AIQ)isusedfortheprocessofensuringthataninstrumentis ...
The text of this information chapter harmonizes, to the extent possible, with the Tripartite International Conference on Harmonization (ICH) documents Validation of Analytical Procedures and the Methodology extension text, which are concerned with analytical procedures included as part of registration ...
Chapter??1225??is?intended?to?provide?information?that?is appropriate?to?validate?a?wide?range?of?compendial?analytical?procedures.??The?validation?of?compendial?procedures may use some?or?all?of the suggested typical?analytical?characteristics?used?in?method?validation?as?outlined?in?Table?1and?