翻訳と辞書 Words near each other ・ Critical period ・ Critical period hypothesis ・ Critical Perspectives on Accounting ・ Critical phenomena ・ Critical philosophy ・ Critical plane analysis ・ Critical point ・ Critical point (mathematics) ・ Critical point (network science) ・ Critical point (set theory) ・ Critical point (thermodynamics) ・ Critical points of the elements (data page) ・ Critical positivity ratio ・ Critical Power Coalition ・ Critical practice ・ Critical process parameters ・ Critical précis ・ Critical Psychiatry Network ・ Critical psychology ・ Critical Quality Attributes ・ Critical Quarterly ・ Critical race theory ・ Critical radius ・ Critical rationalism ・ Critical reaction to 24 ・ Critical reading ・ Critical realism ・ Critical realism (philosophy of perception) ・ Critical realism (philosophy of the social sciences) ・ Critical reconstruction Dictionary Lists mini英和辞書 mini和英辞書 Webster 1913 Latin-English FOLDOC Wikipedia English ウィキペディア

翻訳と辞書　辞書検索 [ 開発暫定版 ] スポンサード リンク Critical process parameters ： ウィキペディア英語版 Critical process parameters Critical process parameters (CPP) in pharmaceutical manufacturing are key variables affecting the production process. CPPs are attributes that are monitored to detect deviations in standardized production operations and product output quality or changes in Critical Quality Attributes. Those attributes with a higher impact on CQAs should be prioritized and held in a stricter state of control. The manufacturer should conduct test to set acceptable range limits of the determined CPPs and define acceptable process variable variability.〔(【引用サイトリンク】url=http://www.biopharminternational.com/biopharm/article/articleDetail.jsp?id=830461&pageID=1 )〕 Operational conditions within this range are considered acceptable operational standards. Any deviation from the acceptable range will be indicative of issues within the process and the subsequent production of substandard products.〔(【引用サイトリンク】url=http://www.propharmagroup.com/blog/critical-process-parameters-and-critical-quality-attributes-why-does-selection-process-take-so )〕 Data relating to CPP should be recorded, stored, and analyzed by the manufacturer. CPP variables and ranges should be reevaluated after careful analysis of historical CPP data. Identifying CPPs is done in stage one of Process Validation: Process design and ???are an essential part of a manufacturing control strategy. One method of defining CPPs is to look at the effect of certain production processes on critical quality attributes. Those production parameters which have a measurable effect on those quality attributes that have been identified as critical can be considered CPPs and must always be in a state of control.〔(【引用サイトリンク】url=http://www.atris-systems.com/cms/index.php?id=217 )〕 ==References== 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Critical process parameters」の詳細全文を読む スポンサード リンク 翻訳と辞書 : 翻訳のためのインターネットリソース Copyright(C) kotoba.ne.jp 1997-2016. All Rights Reserved.