(EQP) (DQ) (IQ) (OQ) OQ (RQ) IQ OQ IQ OQ (ACE) OQ EQP EQP Adobe (i) Q & A (ii) Agilent Compliance Engine (ACE) - 21 CFR Part11 (iii) EE 1.76 EQR 3 PDF
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1 Equipment Qualification Plan (EQP) GC Agilent 7890/7820 (CTC ) Agilent 6890/6850/5890 GC EQP : Agilent_Recommended_EQP_GC
2 (EQP) (DQ) (IQ) (OQ) OQ (RQ) IQ OQ IQ OQ (ACE) OQ EQP EQP Adobe (i) Q & A (ii) Agilent Compliance Engine (ACE) - 21 CFR Part11 (iii) EE 1.76 EQR 3 PDF EQP OQ [1] EQP [2] OQ EQP [3] EQP [4] OQ EQP / / EQP EQP EQP [1] IQ OQ RQ [2] [Adobe Reader ] EQP 2
3 ...4 (DQ)...5 (IQ)...6 (OQ)...7 GC OQ...7 GC OQ...10 OQ EQP...16 (RQ) EQP PDF ( Adobe ) : EE 1.76 Q & A : EE Part 11 (ACE) 3
![[i] GMP/GLP DQ/IQ/OQ/PQ IQ OQ SOP ( SOP #123 : GC ) EQP SOP [ii] SOP EQP SOP EQP [iii] SOP IQ OQ Adobe Agilent Compliance Engine](/docs-images/89/98119774/images/4-0.jpg "(ACE) / [iv] SOP EQP ACE EQP 1 EQP 1 : EQP (a) GC IQ OQ/RQ ACE (b) EQP ACE GC ACE (c) ACE (d) (e) EQP GC ACE (f) (EQR) 1 PDF CD")
4 [i] GMP/GLP DQ/IQ/OQ/PQ IQ OQ SOP ( SOP #123 : GC ) EQP SOP [ii] SOP EQP SOP EQP [iii] SOP IQ OQ Adobe Agilent Compliance Engine (ACE) / [iv] SOP EQP ACE EQP 1 EQP 1 : EQP (a) GC IQ OQ/RQ ACE (b) EQP ACE GC ACE (c) ACE (d) (e) EQP GC ACE (f) (EQR) 1 PDF CD (g) 4
5 (DQ) (DQ) DQ ( ) DQ IQ OQ (URS) DQ USP 31/ USP Chapter <1058> DQ (DQ) (DQ) ( ) (COTS) DQ 1. ACE LC LCMS UHPLC UHPLC_ MS GC GCMS 2. ACE IQ EQR OQ URS EQP OQ OQ OQ Agilent Classic OQPV OQ 5. 5
6 (IQ) IQ 1. : ( ) 2. : 3. : 4. : 5. : 6. : OQ IQ OQ 6
7 (OQ) GC OQ GC N/A 1 = ºC 2 = ºC ( 2 ) <= 1.0 % (ºK ) <= 0.5 ºC N/A 1 : ºC 2 : ºC 3 : ºC (*) 1 : 60.0 ºC 2 3 <= G1888A ºC <= ºC ( ) <= CTC 2.0 ºC >= ºC <= 2.0 ºC /5 >= -2.0 psi <= 0.5 psi = 25.0 psi (172.4kPa) <= 1.2 psi (<= 8.3kPa) (FID) (TCD) (NPD ) <= 10.0 % ( 0.5 ml/min ) <= 25 pa <= 0.10 pa <= 2.50 pa/ <= 35 DU (1 DU = 25 uv) <= 0.15 DU <= 2.20 DU/ : / * 7697 HSS 7
8 (OQ) ( ) GC OQ ( ) (NPD) (ECD) (uecd) (FPD ) (FPD ) S/N (FID/SS/ALS) S/N (FID/SS/HSS) S/N (FID/VI/HSS) S/N (FID/ SS/ ) (5890 ) (5890 ) (5890 ) (5890 ) (5890 ) = DU (1 DU = 1 pa) <= 0.15 DU <= 3.50 DU/ <= 70 DU (1 DU = 5 Hz) <= 0.15 DU <= 1.00 DU/ <= 400 DU (1 DU = 1 Hz) <= 3.00 DU <= DU/ <= 70 DU (1 DU = 150 pa) <= 5.00 DU <= 5.00 DU/ <= 80 DU (1 DU = 150 pa) <= 5.00 DU <= 5.00 DU/ S/N >= 300,000 ( ) S/N >= 240,000 ( ) S/N >= 5,000 ( ) S/N >= 4,000 ( ) S/N >= 4,000 ( ) S/N >= 3,200 ( ) S/N >= 800 ( ) S/N >= 600 ( ) : / 8
9 (OQ) ( ) GC OQ ( ) S/N (FID/ SS/ ) S/N (NPD) S/N (TCD/SS) S/N (TCD/ SS) S/N (uecd) S/N (FPD ) : 1/1000/250 ul ( / FID ALS/Agilent HSS/CTC HSS) : 0.2 ( HSS ) S/N >= 300 ( ) S/N >= 240 ( ) S/N >= 300 S/N >= 5,000 S/N >= 100 S/N >= 1,500 S/N >= 700 ( ) S/N >= 1,000 ( ) RSD <= 1.00 % RSD <= 3.00 % (ALS Agilent HSS) RSD <= 4.00 % (CTC HSS) <= 1.00 % : / GC OQ 9
10 (OQ) ( ) GC OQ GMP/GLP : GMP / GLP LC LCMS UHPLC UHPLC_MS GC GCMS IQ OQ OQ EQP OQ FDA USP GAMP4 OQ ( ) GC ( / ) S/N OQ GC GC OQ (FID ECD TCD NPD FPD MSD ) 1. [ ] : OQ : 2. GC [ ] : : [ ] : : 10
11 (OQ) ( ) GC OQ ( ) 4. [ ] : : 5. [ ] : : 6. [ ] : : 7. [ ] : : GC 8. S/N [ ] : GC S/N : S/N 9. [ ] : : 6 6 %RSD / 11
12 (OQ) ( ) GC OQ ( ) 10. [ ] : : 6 % 11. [ ] : 7693A : ( ) [ ] : : 20 ASTM E
13 (OQ) ( ) GC OQ ( ) GC OQ (FID) GC (µecd/msd ) GC : / 1 1 = ºC/250.0 ºC (OC/ ) =200.0 ºC/300.0 ºC (FPD/ ) 2 : 50.0 ºC 30.0 ºC/min : ºC (r2) = R/F <= % RSD <= 15 ºC/10 ºC (OC/ ) <=15 ºC (FPD/ ) : <= 1.0 ºC/min >= <= 2.0 % LTM N/A = 794 +/- 10 mv 1 2 = 794 +/- 50 mv = 784 +/- 10 mv LTM LTM : 1 = ºC 2 = ºC 2 : 50 ºC 100 ºC/min : 280 ºC <= 1.0 % (ºK ) <= 0.5 ºC : <= 2.0 ºC/min >= <= 2.0 % : / 1. FID [ : ] : ( ) OQ FID n - : n- 1 1 n- ( ) GC ( ) ( ) /
14 (OQ) ( ) GC OQ ( ) 2. GC [ : ] : : (ECD µecd) ) 3. GC [ : ] : GC GC (r2) 3 3 RSD : LTM [ : ] 4 LTM 5 LTM 6 LTM : LTM LTM LTM LTM : LTM LTM S/N LTM LTM LTM- GC GC 14
15 (OQ) ( ) GC OQ ( ) LTM 1. (IP) GC LTM LTM 2. LTM GC 3. LTM GC 4. LTM IP 1 3 LTM LTM LTM : ( ) ( ) 4 ( ) LTM- GC LTM : LTM ( ) LTM- LTM GC GC (Column Zone) (I Zone OutZone) LTM : LTM (LTM ) (r2) 3 3 RSD LTM- GC [Run Log] LTM 15
16 (OQ) ( ) OQ EQP EQP - EQP : : (1) Adobe 2 EQP (2) 2 (3) OQ EQP ( ) [ EQP : ] - ( ) : (1) ACE (2) ACE (3) EQP ( : EQP ACE OQ/RQ ) GC ( OC/ FPD/ µecd/msd ) /250.0 ºC 2 N/A ºC /300.0 ºC 2 N/A ºC GC ºC ºC ºC ºC ºC 2 N/A ºC 3 N/A ºC (ALS) 1.0 ul ( HSS) 1000 ul (HSS*) * 0.02 GC : 50.0 ºC 30.0 ºC/min ºC LTM ºC ºC LTM : 50.0 ºC * HSS ºC/min ºC : : / : (ACE ) : : / : () 16
17 (RQ) OQ ACE RQ / EPC OQ/PV GC GC OQ RQ ACE RQ ( ) OQ ( ) (EQP) 2 OQ (limit1) (limit2) Standard_EQP Limit1 Limit2 Custom_EQP Agilent Compliance Engine (ACE) Limit2Limit1 OQ 17
18 (ACE ) : R&D : Dr. Jonathan Gray () : Doug McDougall ( ) labcompliance.com Ludwig Huber ACE EQP GC A A A A A A A A A A PDF InDesign Measure of Confidence GC ACE GC 7696 HSS 3 GC (1) : ( ) Perkin Elmer HS40XL TurboMatrix 40 ( ) (1) (FID) (2) GC : (3) 7693 ALS (4) Agilent 7820 Varian GC (5) ( ) (1) ( ) : (a) FID CTC HSS 3 % 4 % (b) < 0.5 psi/5 min (c) (d) 100 ºC (2) G1883A HSS (3) FPD (P/N ) (4) : EQR Certificate of System Qualification ( ) Chromatography Report ( ) EQR Errors and Corrections ( ) Data Transfer Audit Log ( ) kpa A A GC - EQP Published in Japan, December 2, 2011
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