PDA TR60 附录1 决定批次的统计学方法
The average number of lots until the first lot failure is ARL =1/p. where p is the lot failure rate that is important to detect. 直到出现第一批失败的平均批数量(ARL)=1/p,其中 p 为批失败率,检测出 PDA-TR60-附录1-决定批次的统计学方法 来自淘豆网www.taodocs.com转载请标明出处....
感谢风险，如果有中文版，就更好了
PDATR60中关于关键质量属性CQAs的描述 关键质量属性 A Critical Quality Attribute (CQA) is a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality. CQAs can be associated with...
PDA TR60-2-2017 Annex 1 Oral Solid Dosage Semisolid Dosage Forms英文原版资料.pdf,Technical Report No. 60-2 Process Validation: A Lifecycle Approach Annex 1: Oral Solid Dosage/ Semisolid Dosage Forms Process Validation: A Lifecycle Approach — Annex 1: Or
understanding of the type and amount of information that can be leveraged from pre-qualification activities. This approach means that Stage 2 activities may be underway during and prior to completion of all Stage 1 activities. 只要充分理解了工艺要求和工艺系统的关联性,系统确认计划开发报告随时可以起草...
6.2.1 实验设计 The statistical design of experiments (DoE) is a powerful tool often used during Stage 1 Process Design. Goals of DoE are to: 实验设计是一种非常有效的工具,经常在工艺验证的第 1 阶段(工艺设计)使用。实验设计的目标是:
x 本帖最后由 小普 于 2021-5-18 15:33 编辑 PDA TR60-2 工艺验证：生命周期方法 附录1口服固体...
5点中有4点在1西格玛限外; • 6 in a row increasing or decreasing. 连续6点递增或递减。 Figure 6.2.2.1-1 shows an example of an Xbar/S chart for fill weight, where five vials from a singlehead filler were sampled every 15 minutes over a six hour production order or lot, for 24 sam...