GxP (OOS) 2 2 2 2 2 1 3 4 5 2 5 6 7 3 LabX 7 8 8 8 11 11 RDID 11 RFID 12 13 14
HPLC LabX 1-3 LabX 2 -
1 1 1 1-3
1 ISO 17025 GxP GxP FDA 1 (21 CFR 211.194(a)) 2012 7 18 <redacted> <redacted> <redacted> HPLC FDA 2013 5 20 FDA 4 -
[ 1] [ 2] GxP 1., 25 2. LabX 2 2 1-5
1 2 2 1 / GxP [ 1, 2] 6 -
2 3 3 LabX - LabX LabX GxP [ 3, 4] LabX 3 LabX LabX LabX SOP LabX LabX LabX LabX - 7
LabX LabX 3 LabX 1 2 LabX LabX LabX - P-58 128QR2D 1 LabX 1 25% 194% LabX 135% 1000 4-5 10000 1 2 2 1 220 8 -
FTE FTE 1 1. 2. 3. LabX * 25 20 8.5 * 2 1. 2. 3. LabX 0.79 FTE 0.63 FTE 0.27 FTE 0 0.16 FTE 0.52 FTE 25% 194% 134% - 9
2 GxP 3 1. GxP 2. 3. LabX GxP 1 3 LabX (LIMS) [ 7] 5% 0.3% 100 4664 67.6% 23.6% 8.8% [ 8] LIMS 10 10 -
LabX GxP (GAMP) 5 [ 5] GAMP [ 6] LabX LabX 20-40 LabX 3 40 0.18 FTE 2 0.27 FTE 0.09 FTE 0.27 FTE RFID RFID 6-10 20µL 200µL 20 µl100 µl 200 µl 200µL RSD - 11
1. RFID RFID RFID RFID 2. QuickCheck RFID RFID RFID RFID RFID RFID 12 -
(RFID) - 13
1. FDA Guide to Inspections of Pharmaceutical Quality Control Laboratories (1993), section 13 2. FDA Guide to Inspections of Pharmaceutical Quality Control Laboratories (1993), section 14 3. Electronic Records; Electronic Signatures Final Rule, 21 CFR 11 4. EU Good Manufacturing Practice regulations, Annex 11 computerised systems 5. Good Automated Manufacturing Practice (GAMP) Guide, Version 5, International Society for Pharmaceutical Engineering, Tampa, Florida (2005) 6. GAMP Good Practice Guide, A Risk-based Approach to Compliant Laboratory Computerized Systems, International Society for Pharmaceutical Engineering, Tampa Florida (2012) 7. A.M. Chambers, J. Elder and D. StJ. O Reilly, Annals Clinical Biochemistry, 23 (1986) 470-473 8. R. Black, P. Woolman and J. Kinsella, Presented at American Society of Anaesthesiologists Annual Meeting, New Orleans, Louisiana, October 2001 9. Current Good Manufacturing Practice for Finished Pharmaceutical Products 21 CFR 211.68(b) Mettler-Toledo AG CH-8606 Greifensee, Switzerland +41-44-944 22 11 www.mt.com - 09/2013 Mettler-Toledo AG 30101213