Green Light GxP HPLC 2

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Excellence Plus Good Manufacturing Practice (GMP) 1 (OOS) (OOT) (OOE) 2 2

1 Excellence Plus Good Manufacturing Practice (GMP) 1 (OOS) (OOT) (OOE) LevelControl 8 9 profact profact Advanced 9 TestManager

2 Green Light GxP HPLC 2

3 GMP GLP (USP) FDA (PAI) FDA 1 GxP GxP (GMP) (GLP) (USP) GMP GLP GMP [ 1 2] OECD GLP [ 3 4 5] EU GMP 2 [ 6] GMP GMP [ 7 8] [ 9 10] (HPLC ) EU GMP EU GMP 4 [ 11] GMP [ 12] 3

4 Green Light GXP (USP) General Chapter/ Information 3 <41> Balances ; <1251> Weighing on an Analytical Balance ; <1058> Analytical Instrument Qualification. USP Chapter <41> 2 <41> Balances <1251> Weighing on an Analytical Balance [ 13 14] USP Chapter (<1000> ) <1000> <1999> 2 USP <41> USP 10 5% Chapter (AIQ) USP <1058> [ 15] USP <1251> [ 14] USP <1251> ( (DQ) (IQ) (OQ) (PQ) ) [ 14] () 2005 [ 16] FDA 2012 (CPG) [ 17] CMC CDER ( ) CMC CGP CMC / / 4

5 GxP 1 (CRO) (CMO) 2009 FDA post 483 [ 18] GMP DQ IQ OQ ID 5

6 Green Light FDA 1 1 ph API (FDA ) 1 2 < > (FDA ) 3 1 API 500mg (0.5g) 100mg (0.1g) 10mg (0.01g) (FDA ) 1 [ 15] OQ 6

7 4 USP <41> 4 10mg QC ( ) (FDA ) [ 7 15] [ 19] [ 17] CMC / / 7

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12 1. Current Good Manufacturing Practice for Finished Pharmaceutical Products 21 CFR Current Good Manufacturing Practice for Finished Pharmaceutical Products 21 CFR Good Laboratory Practice for Non-Clinical Studies, 21 CFR and Principles of Good Laboratory Practice, Organisation of Economic Cooperation and Development (OECD), Section 4. Apparatus, Material, and Reagents clauses 1 and 2 5. Good Laboratory Practice, Ordinance 21, Ministry of Health Labour and Welfare Chapter 3 Testing Facilities and Equipment (Equipment), Article EU Good Manufacturing Practice regulations, Chapter 3 Facilities and Equipment, clauses 3.40 and Current Good Manufacturing Practice for Finished Pharmaceutical Products 21 CFR (b) 8. Current Good Manufacturing Practice for Finished Pharmaceutical Products 21 CFR (b)(4) 9. Current Good Manufacturing Practice for Finished Pharmaceutical Products 21 CFR (a) 10. Current Good Manufacturing Practice for Finished Pharmaceutical Products 21 CFR (c) 11. Current Good Manufacturing Practice for Finished Pharmaceutical Products 21 CFR EU Good Manufacturing Practice regulations, Chapter 4, clause United States Pharmacopoeia <41> Weights and Balances, Rockville, Maryland, United States Pharmacopoeia <1251> Weighing on an Analytical Balance, Rockville, Maryland, United States Pharmacopoeia <1058> Analytical Instrument Qualification, Rockville, Maryland, Able Laboratories, FDA Form 483 Observations, July Compliance Program Guide Pre-Approval Inspections published May 2010, effective May FDA Post 483 Inspection Program August GMP (Good Weighing Practice) The Standard, Science Based Weighing, 20. FDA Questions and Answers on Current Good Manufacturing Practices, Good Guidance Practices, Level 2 Guidance Laboratory Controls Guidances/ucm htm#1 (accessed 18 Aug 2013) TEL : FAX: TEL : FAX: sales.admin.jp@mt.com F 09/2013 Mettler-Toledo AG Printed in Switzerland

White Paper 計量プロセスにおける GxP OOS 目次 LabX RFID 11 RFID 11 RFID

White Paper 計量プロセスにおける GxP OOS 目次 LabX RFID 11 RFID 11 RFID 計量プロセスにおける GxP OOS 目次 2 2 2 2 2 1 3 4 5 2 5 6 7 3 LabX 7 8 8 3 8 11 RFID 11 RFID 11 RFID 12 13 14 Error Sources HPLC 現在のプロセスフロー : LabX 1 3 LabX 1 1 2 2 3 3 1 プロセス 1: 手作業による計量および記録 1 図 1: 1 台の分析天びんによる手動ワークフロー