1 はじめに
Contents
1.2. 3 modular validation system velidation 0 0 0 0 wi
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4. 30206Q00000000000 4000000000 installation Qualification IQ 40100000 Q00 0 LCG 00 5 40101000000 Q0000 40102
5. 1 Good Laboratory Practice GLPO Good Manufacturing Practice ISO IEC Guide25y 1S0 17025 0 0 OO OOO0U0O0000000000000000000000
6. 60204000000 3 b OOOOHO000000000000
7. 4 PhanmAnalysis Equrope Conference UK Pharmaceutical Analytical Sciences Group PASG Pham Tech Europe 40 United States Pharmaceutical Manufacturing Association O 0000000000 design qualification DQ OD 00 0 0 0 0 0 installation qualification 1Q 0 0 0 00 T T operational qualification OQ 00 0 00 0 00 0 performance qualification PQ Laboratory of the Goverment Chemist equipment qualification EQ OOOO OOOU0O000000000000000000000 OO Analytical Instrument Association IQ PQO voluntary guideline
8. 5 60000000 GY Performance Qualification PQ 6 1 5 E 0 o 0 Oo oii AAO 601010000000 60 10 2
9. 6 2 602010000 60 20200000000000 602030000
10. 402 4 2 1 5 OUUUU 402020000000000000000000
11. 6020500000 1 7000 UU 1 ISO ICE Guide25 General requirements for the competence of calibration and testing laboratories 3rd edition 1990 International Organization for Standardization C
12. 2010400 OOOUOO0O000 0H 00 0000000000000 00 Standard Operating Procedure SOPII 2 2 PSS 49 R i N oan CD a 00000000000000000000000 09 30000000 Gg Design Qualification DQ EO
13. 301000000Qa000 302 DQ0000 3020100000000000 30202 000000000000000 30203 0000
14. 5740000000 Preventative Maintenance 7 Whenever maintenance and calibration operations are necessary they must be carried out before EQ PM 0 A OOO COO OOo Oooo PMO 5 5
15. 20102 000000000000 5x 10 00 LOABUL 1 2010300 0
16. sul A Et 9 2 201000000000 OOO SGMPafOOOOO0O0000000000000000 201010000000
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18. OOO0 0000000 Co EI Ey Ey E 5 Operational Qualification OQ 1 9 LECH OO 5 s02 0000000 503 0Q0000 5 5 5
19. ase postale 56 CH 1211 Geneve 20 Switzerland 2 ISO IEC 25 3 F M Leng D Morrison and R P Munden Presented as poster paper and at the PhanmAnalysis Europe Dusseldorf May 4 F M Leng D Morrison and R P Munden Pham Tech Europe November 1995 40 1995 5 P Bedson and M Sargent J Accred Qual Assur 1 265 1996 6 Voluntary Guideline for OQ and PQ The Analytical Instrument Assosication AIA Alexandria VA 1996 7 www chemagilent cony cag country J P index htm 8 3 9 11 7 158 10 P Bedson and M Sargent J Accred Qual Assur 1 6 1996 11 Design Qualification DQ covers all procedures prior to the installation of the system in the selected environment DQ defines the functional and operational specifications of the instrument and details the conscious decision in the selection of the supplier P Bedson and M Sargent J Accred Qual Assur 1 265 1996 12 Installation Qudiification covers all procedures relation to the installation of the instrument in the selected envir
20. onment establishes that the instrument is received as designed and specified that it is properly installed in the selected environment and that this environment is suitable for the operation and use of the instrument P Bedson and M Sargent J Accred Qual Assur 1 265 1996 13 Operational Qualification OQ is the process of demonstrating that an instrument will function according to list operational specification in the selected environment P Bedson and M Sargent J Accred Qual Assur 1 256 1996 14 W B Furman and T P Layloff AOAC Int 77 1314 1994 15 Performance Qualification is defined as the process of demonstrating that an instrument consistently performs according to a specification appropriate for its routine use PQ provides the continuing evidence of control and acceptable performance of the instrument during its routine use P Bedson and M Sargent J Accred Qual Assur 1 265 1996
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