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...
PDA TR60-2 工艺验证:生命周期方法 附录1口服固体半固体制剂-2017(英文) 基于生命周期和风险评估方法的工艺验证 PDA TR 60 工艺验证_生命周期方法 2013年版 内容摘要 基于生命周期方法的工艺验证及要求 基于生命周期方法的工艺验证及要求讲解 AAPS(美国药物科学家协会)固体口服制剂工艺验证卷二-生命周期方法的应用 ...
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
中文-PDA TR60 工艺验证:生命周期方法
TR 60-2 工艺验证 附录1:口服/半固体剂型 (2017年)
近⽇,PDA发布了最新的技术报告TR 60-3《⼯艺验证 - ⽣命周期⽅法,附录2:⽣物制药原料 药⽣产》(Technical Report No. 60-3 Process Validation: A Lifecycle Approach,Annex 2:Biopharmaceutical Drug Substances Manufacturing )PDA技术报告60-3解决了在⽣物制药⽣产中⼯艺验证的实施问题。也...
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6.2.2.1.2 Types of Control Charts 控制图的种类 Control charts may be used for both variables and attributes data. Variables data are those that are measured quantitatively, such as potency, weight, and pH. Attributes data are those obtained by counting, such as number of rejected lots per mo...
感谢风险,如果有中文版,就更好了