翻訳と辞書 Words near each other ・ Prochoma ・ Prochoreutis ・ Prochoreutis alpina ・ Prochoreutis alpinoides ・ Prochoreutis argyrastra ・ Prochoreutis arisema ・ Prochoreutis atrox ・ Prochoreutis bella ・ Prochoreutis brunescens ・ Process theology ・ Process theory ・ Process theory of composition ・ Process tomography ・ Process tracing ・ Process trailer ・ Process validation ・ Process variable ・ Process variation (semiconductor) ・ Process Vision ・ Process Vision (Dutch company) ・ Process window ・ Process Window Index ・ Process-based management ・ Process-centered design ・ Process-data diagram ・ Process-driven application ・ Process-oriented programming ・ Process-oriented psychology ・ Process.h ・ Processability theory 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 Process validation ： ウィキペディア英語版 Process validation Process Validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation.〔(【引用サイトリンク】url=http://www.fda.gov/downloads/Drugs/Guidances/UCM070336.pdf )〕 The purpose of process validation is to ensure varied inputs lead to consistent and high quality outputs. Process validation is an ongoing process that must be frequently adapted as manufacturing feedback is gathered. End-to-end validation of production processes is essential in determining product quality because quality cannot always be determined by finished-product inspection. Process validation can be broken down into 3 steps: process design, process qualification, and continued process verification. ==Process Design== In this stage data from the development phase are gathered and analyzed to define the commercial manufacturing process. By understanding the commercial process a framework for quality specifications can be established and used as the foundation of a control strategy. Process design is the first of three stages of process validation. Data from the development phase is gathered and analyzed to understand end-to-end system processes. These data are used to establish benchmarks for quality and production control. 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「Process validation」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.