対訳資料：PIC/S(EU) GMP Annex 1 Draft

参考資料 EU-GMP Annex -1 改定案 1 / 121 頁 訳文には誤訳、誤謬、タイプミスがあります。訳文は目安ですので、判断と行動は必ず原文によって行って下さい。

三極のHEPAフィルターの規格について - ph-s.com

三極のHEPAフィルターの規格について ファルマ・ソリューションズ 2008.4.2 各国においてフィルターの規格、試験方法については違いがあります。

無菌製剤に適用されるアイソレータ技術について

05.5.27-5 ISPEの調査より Filling Barrier Isolators 1998 2000 2002 84 172 199 Companies Using Barrier Isolation 1998 2000 2002 38 56 67 Barrier Isolator Filling Lines

  Isolators

( 配付用）高生理活性設備Part 1 - ph-s.com

FDA CDER (Safety Officer)の発表資料より 2008年ISPE Washington Conference 1．現行各極GMP・設備・施設の専用化の要件

  Ispe

逸脱管理の基本的事項（イベントと逸脱）

ISO Guide 73：2009 （JIS Q 0073）「リスクマネジメント−用語（Risk management -Vocabulary）」 （リンク：2018.10.21現在） に は、「事象」は、次のように定義されています： ある一連の周辺状況の出現又は変化 （Occurrence or change of a particular set of circumstances）。

  Guide

Power Up Your Analytical Method Transfer

BioPharma Solutions Connect to the resources you need. Webinar – May 16th 2007 Power Up Your Analytical Method Transfer

  Your, Methods, Transfer, Analytical, Up your analytical method transfer

ASEAN Life Sciences Conference and Exhibition - …

1 CRITICAL UTILITY DESIGN AND MAINTENANCE Gaston Loo Maintenance Lead MSD SINGAPORE ASEAN Life Sciences Conference and Exhibition - 2013 …

  Life sciences conference and exhibition, Life, Sciences, Conference, Exhibition, Life sciences conference and exhibition 2013, 2013

Process Validation for Medical Devices - Ombu …

Process Validation for Medical Devices 2 Ombu Enterprises Instructor Introduction • Dan O’Leary – Dan has more than 30 years experience in quality, operations,

  Devices, Medical, Process, Validation, Process validation for medical devices

Quality Management systems - Process Validation …

GHTF Study Group 3 - Quality Management Systems Process Validation Guidance – January 2004 Page 2 Process Validation Guidance Contents 0 Introduction

  System, Management, Quality, Process, Validation, Guidance, Quality management systems process validation, Quality management systems process validation guidance

Annex 4 Guidelines on viral inactivation and …

150 G Annex 4 Guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products List of abbreviations and definitions used in this Annex 151

  Guidelines, Procedures, Removal, Viral, Guidelines on viral inactivation and, Inactivation, Guidelines on viral inactivation and removal procedures

Validation of Production Processes for Vaccines for …

Page 2 of 37 This guidance document “Validation of Production Processes for Vaccines for WHO Prequalification - Compliance Expectations” is one of a series developed by

  Validation, Compliance, Prequalifications, Expectations, For who prequalification compliance expectations

Leak Rate Testing for Freeze Dryers

2 Assurance of the vacuum integrity of freeze-dryers used for the manufacture of sterile pharmaceutical products is essential for GMP operations; however, there is currently

  Testing, Rates, Freeze, Lake, Dryer, Leak rate testing for freeze dryers