Review Document Standard EQP LCMS

EQUIPMENT QUALIFICATION PLAN
(EQP)
Agilent Enterprise Edition Compliance Services
Qualification of Analytical Scale LCMS Systems

Agilent 6100, 6200, 6300, 6400 and 6500 Series LCMS Systems with
Agilent 1100/1200 Series LC and Agilent Infinity Series LC with
operating pressure under 400 bar.
REVIEW DOCUMENT NAME:

Agilent_Recommended_EQP_LCMS
Page 1 of 22
Agilent_Recommended_EQP_LCMS Document Released: April 2014 Enterprise Edition Compliance Services
How to Use This Document
This document is an Equipment Qualification Plan (EQP). It covers Design Qualification (DQ), Installation Qualification (IQ),
Operational Qualification (OQ), scheduled repeat OQ, and Re-Qualification after Repair (RQ). It contains information on how
Enterprise Edition Compliance Services work, and also provides a full list of the tests and checks performed as part of Agilent’s
standard Enterprise Edition IQ and OQ services.
The hardware IQ and OQ procedures listed in this document include fixed tests and checks at Agilent recommended criteria
and limits. All tests in this document exist in all Agilent delivery tools. However, customer-selectable variance to the standard
hardware OQ setpoints is possible to enable testing of chromatography system(s) over their intended range of use. All setpoint
menu selections in the Variance Section are with the validated range of Enterprise Edition.
The inventory of systems covered by the EQP will be maintained as a separate record.
To facilitate the EQP review and approval process, this document is best viewed on-screen using Adobe ®. Also, there are
several pdf file attachments included with this document: (i) Question and Answer document; (ii) 21 CFR Part11 Conformance
Checklist for the Agilent Compliance Engine (ACE) – the Enterprise Edition delivery tool; (iii) EE 1.76 EQR comparison with
previous revisions.
To approve this EQP simply print to paper and sign. To add variances see instructions below. Keep copies for your own records.
Verbal confirmation of approval is sufficient for Agilent service to proceed with scheduling and delivery.
To make variances to the standard hardware OQ setpoints:
[1] Use the pull-down button to select the alternative approval statement “shall follow...the standard specifications with
VARIANCES to OQ setpoints...”; [2] Complete the “EQP Record of Variances to Setpoints from Standard OQ Specifications”
later in this document; [3] Print EQP to paper and [4] ENSURE THE VARIANCE REQUEST IS COMMUNICATED to Agilent service
engineer BEFORE first OQ delivery starts. Do not e-mail/FAX/post copies of your approved EQP to Agilent. BUT CUSTOMER
MUST PROVIDE A COPY OF ANY EQP WITH VARIANCES TO AGILENT OPERATOR ON-SITE TO ENSURE THE VARIANCES ARE
ENTERED INTO DELIVERY TOOL. NO EXTRA FEE TO DELIVER SETPOINT VARIANCES.
For a full process description, click here to go to the EQP Record of Variances section.
Approval of EQP
The undersigned person(s) approve the following:
[1] the use of Enterprise Edition Compliance Services and delivery of the IQ and/or OQ and/or RQ checks and tests appropriate
to the actual configuration, make, and model of those systems covered by the service;
[2] the specifications described in this Standard EQP Review Document where the tests, setpoints, and limits shall follow...
the STANDARD
the STANDARD FIXED
FIXEDAgilent
Agilentrecommended specifications.
recommended specifications.
Name and Role Signature and Date
[You cannot save form entries with Adobe Reader. Typed entries and menu selections are printed on your official paper copy when you print.]
DO NOT SEND AGILENT A COPY OF YOUR APPROVED EQP. THIS DOCUMENT IS YOUR OWN RECORD OF APPROVAL.
© Agilent Technologies, Inc. 2014 Page 2 of 22 No reproduction, translation, or use without permission
Contents
To go to a section, click on one of the section titles below.
Sections Page
How Enterprise Edition Compliance Services Work.................................................................................................. 4
Design Qualification (DQ)............................................................................................................................................... 5
Installation Qualification (IQ) Hardware...................................................................................................................... 6
Operational Qualification (OQ) Hardware.................................................................................................................... 7
Standard OQ Test Specifications for Analytical-Scale LCMS Systems:
LC Modules........................................................................................................................................................................... 7
Single Quadrupole............................................................................................................................................................... 9
Triple Quadrupole.............................................................................................................................................................. 10
Ion Trap.......................................................................................................................................................................... 11
Q-TOF............................................................................................................................................................................. 12
TOF................................................................................................................................................................................. 13
OQ Test Design and Rationale for Analytical Scale LCMS Systems.............................................................................. 14
EQP Record of Variances to Setpoints from Standard OQ Specifications..................................................................... 19
Re-Qualification after Repair (RQ) Hardware............................................................................................................ 20
Legal, Endorsement, and Revision History................................................................................................................ 21
PDF file attachments to this electronic EQP (open the attachments folder for this document in Adobe):
Why Has Agilent Introduced the New

Compliance Service, Called Enterprise Edition?
Introduction What Are The High Level Changes In
Enterprise Edition And What Were The
Agilent (then we were HP Analytical) introduced
Drivers For These Changes?
OQPV for our own LC and GC instruments in the early
1990’s and since then we have delivered well over The first big driver was the software environment.
100,000 OQPV reports to customers around the world. A greatly increased number of chromatography data
Despite the undoubted success and acceptance of our system (CDS) products are available to control
Table of contents: [click on title for fast navigation] old OQPV (now called Classic Edition to distinguish LC and GC systems. Agilent has ChemStation,
from the new Enterprise Edition service) times have Cerity, EZChrom, OpenLab and some specialist
What Are The High Level Changes In Enterprise Edition changed. Expectations and requirements of an LCMS/GCMS software. Our customers also use
And What Were The Drivers For These Changes? OQ have slightly shifted. The number and type of Empower, Chromeleon, Atlas, Turbochrom and many
Any Other Practical Or Process Changes In instruments and software used by our customers has others. Classic OQPV was built into ChemStation
Enterprise Edition? increased. And of course we are truly in the new world software. The Classic OQPV is a miracle of validated
of computers and electronic media. and almost fully automated OQ testing. But these
Let’s Dive Into The Details – How Do The Protocols And benefi ts are therefore limited to Agilent instruments
Tests In Enterprise Edition Compare To Classic Edition? So Agilent set out with a team of international experts
running on ChemStation. To provide all our customers,
3 years ago to create an upgraded compliance service
List Of Enterprise Edition OQ Tests Versus and customers of non-Agilent instruments, a single
that would meet the new demands but crucially
Classic OQPV Tests For LC: OQ solution as good as (or better than) OQPV – it
maintain the fundamental requirements:
was clear we had to develop an automation tool
What About The Reports, How Are These Different • Always pass FDA and national agency audits independent of ChemStation and any other CDS.
To OQPV Reports? without over-testing or under-testing;
The Agilent Compliance Engine (ACE) is our new
What Would I Have To Do If I Wanted To Move My • Challenge the LC or GC system with a scientifically software tool that manages the workflow and
Annual OQ Service From Classic To Enterprise Edition? sound methodology that provides valuable protocols, calculates results and produces the
What Are The Main Risks To Migrating To performance data. reports. Naturally it is fully validated and tested.
Enterprise Edition And How To Avoid Them? • Meet the quality needs of customers and the spirit & Our service engineers carry “ACE laptops” in the
intention of the GLP & GMP laws. same way as they carry “ChemStation laptops”.
Finally, Can You Summarize The High Level
• Offer this service at a cost-effective price that Alternatively our contract customers can have the
Comparison Of Enterprise Edition Versus
makes it more than just worthwhile – we hope it ACE software on their own laptops or installed with
Classic Edition Compliance Services?
is the simplest & best qualification choice that a Agilent OpenLab networked CDS.
customer can make.
EE 1.76 Comparison Part 11 Checklist (ACE) Q & A: Why Change?
How Enterprise Edition Compliance Services Work

Enterprise Edition is designed to fit the traditional quality systems used by firms and recognized by regulatory agencies
worldwide.
How Enterprise Edition aligns with a traditional, paper-based methodology is described below:
[i] Policy documents dictate the need for validation & qualification of GMP/GLP systems and usually mention the DQ/IQ/OQ/
PQ model. The precise procedures for IQ & OQ for each type of equipment are prescribed in an approved SOP, perhaps called
SOP #123: Qualification of Analytical Scale LCMS Systems. In Enterprise Edition, the EQP has the same role as the traditional
Qualification SOP.
[ii] The traditional SOP provides lists of tests & limits for the range of system configurations found in the lab or department. The
EQP follows this concept. The inventory of systems covered by an SOP or EQP changes over time – so this is kept as a separate
record.
[iii] The traditional Qualification SOP typically has blank results forms as attachments to be photocopied for each IQ or OQ event
– the results recorded in ink with manual calculations. In Enterprise Edition this execution process is streamlined and automated
by use of Adobe forms and the Agilent Compliance Engine (ACE) delivery tool. It provides reports with no hand-writing errors;
validated calculations; automated pass/fail report; traceability to raw data and a count of number of times a test was run. This
automation provides efficiency and enforces compliance to procedure.
[iv] The traditional Qualification SOP is approved and released only once – replacing need to author individual protocols for
each chromatography system. This is the same concept for the EQP. The appropriate tests for each individual configuration
are automatically selected by ACE from the list in the approved EQP – at time of delivery. The final reports are unique for each
system and each qualification event – but the single approved EQP can cover a lab, department or as wide a scope as desired.
(v) In the traditional qualification methodology there is no convenient provision to record the actual workflow of the tests
execution and results. In the event that a test is repeated during the Enterprise Edition delivery, ACE maintains a counter per
test which is automatically incremented for GxP compliant work, and the engineer should generate a deviation note within the
ACE report.
Figure 1:
This EQP Review Document is the record of IQ checks and OQ / RQ tests, setpoints, and limits for analytical scale LCMS systems. The tests already exist in the automation
tool called ACE and are ready to run after the EQP is approved. ACE holds the test forms applicable to the full range of LCMS configurations plus a validated calculation
and report generator engine. At time of delivery, a record of individual system configuration is made by the operator and entered into ACE. The correct test forms are
automatically selected by ACE from its internal catalog of test designs. Each test in the catalog has a blank results template form. The appropriate setpoints and limits for
the individual LCMS system are added by ACE to the forms according to the approved EQP. When each test is run, the results are calculated and forms completed and then
collated to make a single final report called an Equipment Qualification Report (EQR), which is provided in secure PDF format or optional CD disk – printable to paper and
stored in a binder and/or customers’ network storage system.
Design Qualification (DQ)

Design Qualification (DQ) for commercial lab instruments is recommended by some, but not all, guidances and procedures.
Defintions of DQ found in guidances and firm-specific validation procedures vary widely around the world. Some firms require
nothing more than a record (such as certificate) from the instrument manufacturer demonstrating that the lab system has
been designed for purpose and manufactured to a quality standard. Others treat DQ as the development of a user requirement
specification document (URS) which can be matched to the IQ and OQ specifications for a manufacturer. Other firms consider
DQ as including the vendor selection activities.
USP Chapter <1058> pre-published in USP 31/Supplement defines DQ:
Design qualification (DQ) is the documented collection of activities that define the functional and operational specifications of
the instrument and criteria for selection of the vendor, based on the intended purpose of the instrument. Design qualification
(DQ) may be performed not only by the instrument developer or manufacturer but also may be performed by the user. The
manufacturer is generally responsible for robust design and maintaining information describing how the analytical instrument
is manufactured (design specifications, functional requirements, etc.) and tested before shipment to users. Nonetheless, the
user should ensure that commercial off-the-shelf (COTS) instruments are suitable for their intended application and that the
manufacturer has adopted a quality system that provides for reliable equipment. Users should also determine capability of the
manufacturer for support installation, services, and training.
For your reference, Agilent provides the following statements for DQ purposes:
1. All Agilent LC, LCMS, UHPLC, UHPLC_MS, GC, and GCMS hardware and software laboratory products including the ACE
software used to deliver qualification services, are designed, manufactured, and tested according to Agilent internal Quality
Life-Cycle Development Procedures.
2. Certificates of Agilent testing, validation, and conformance to standards are provided with new Agilent instruments
and similar certification is provided for ACE software. These documents are checked and recorded in Enterprise Edition
Compliance Services IQ.
3. Agilent maintains information describing how products are manufactured and maintains a problem and bug reporting
program as required by international software quality guidelines.
4. The OQ specifications in this EQP can be used, as appropriate, by the user to prepare URS. The OQ specifications in this EQP
represent the levels of performance acceptable to regulatory agencies for the technique; conform to typical specifications
found in Validation literature; are equally suitable for OQ at installation and on-going OQ throughout operational lifetime; are
equivalent to the OQ specifications published in the legacy Agilent Classic OQPV protocols; and are suitable for most user
requirements.
5. Agilent Technologies is capable of installation, support, preventive maintenance, on-going qualification and re-qualification
after repair and user training worldwide.
Installation Qualification (IQ) Hardware

Hardware IQ checks and tests for Agilent software products include the following:
1. Purchase Order Documents:
Allows the customer to verify that the instrument being qualified matches their design requirements (if available) and
purchase order.
2. Preparation and Installation Documents:
Gathers and records information about preparation and installation documents.
3. System and Installation Documentation:
Gathers and records information about reference and user manuals for initial installations.
4. Product Quality Assurance Documents:
Collects and records certificates and other forms that verify that the vendor has developed and built the product according to
internal standards.
5. Start Up Test:
Verifies that all modules start up properly.
6. Instrument Check:
Demonstrates that all modules of the instrument are correctly installed and connected. It does not test instrument
performance as fully as OQ. This test is not necessary and therefore skipped if an OQ is to be performed by Agilent operator
at installation after IQ.
Operational Qualification (OQ) Hardware

Standard OQ Test Specifications for Analytical-Scale LCMS Systems: LC Modules
Test Name Setpoints and Parameters Limits

Pump Flow Accuracy and Precision Flow Rate 1 = 0.500 ml/minute Accuracy ≤ 5.00 % from setpoint
Flow Rate 2 = 5.000 ml/minute* Precision ≤ 0.50 % RSD
Column Temperature Accuracy Temperature 1 = 80.0 °C Diff. from setpoint ≤ 3.0 °C (≥ 60 °C)
and Stability Temperature 2 = 40.0 °C** Diff. from setpoint ≤ 2.0 °C (< 60 °C)
Stability measured at Temperature 2 Stability ≤ 1.0 °C
Wavelength Accuracy (UV-Vis) Wavelength 1 = 205 nm [Maximum] Accuracy ≤ 2 nm
Wavelength 2 = 245 nm [Minimum]
Wavelength 3 = 273 nm [Maximum]
Wavelength Accuracy (FLD) Wavelength 1 = 350 nm [Maximum] Accuracy ≤ 3 nm
Signal Noise and Drift (VWD) ASTM baseline noise Noise: ≤ 0.040 mAU
Slope of regression fit for drift Drift ≤ 0.500 mAU/hr
Signal Noise and Drift (DAD, MWD) ASTM baseline noise Noise: ≤ 0.050 mAU
Slope of regression fit for drift Drift ≤ 5.000 mAU/hr
Signal Noise and Drift (RID) ASTM baseline noise Noise: ≤ 10.000 nRIU
Slope of regression fit for drift Drift ≤ 400.000 nRIU/hr
Signal Noise and Drift (ELSD) ASTM baseline noise Noise: ≤ 2.000 mV
Slope of regression fit for drift Drift ≤ 5.000 mV/hr
Signal Noise and Drift (CD) ASTM baseline noise Noise: ≤ 0.100 uS
Slope of regression fit for drift Drift ≤ 10.000 uS/hour
Signal to Noise (UV-Vis) Signal height is divided by ASTM baseline noise Signal to noise ≥ 3,000
for known concentration and known conditions.
Signal to Noise (RID) Signal height is divided by ASTM baseline noise Signal to noise ≥ 2,000
for known concentration and known conditions.
Signal to Noise (FLD) Signal height of Raman peak is divided by noise Signal to noise ≥ 400
at different wavelength in flat region of emmision
spectrum.
* 2.000 ml/min for G4220B 1290 pump
** T2 = 60.0 °C for 1120 and 1220 systems
Key: Fixed setpoints/limits Variance allowed for setpoint(s)
Operational Qualification (OQ) Hardware (continued)

Standard OQ Test Specifications for Analytical-Scale LCMS Systems: LC Modules (cont.)

Injection Precision Injection volume on column = 20 ul Height RSD ≤ 2.00 %
(UV-Vis, RID) Area RSD ≤ 1.00 %
Injection Precision Injection volume on column = 20 ul Height RSD ≤ 3.00 %
(ELSD) Area RSD ≤ 3.00 %
Injection Precision (CD) Injection volume on column = 25 ul Height RSD ≤ 1.00 %
Area RSD ≤ 1.00 %
Injection Carry Over Injection volume on column = 20 ul Height carry over ≤ 0.40 %
(UV-Vis, RID) Area carry over ≤ 0.20 %
Injection Carry Over (CD) Injection volume on column = 25 ul Height carry over ≤ 1.00 %
Area carry over ≤ 1.00 %
Response Linearity 5 concentrations of certified Coefficient of determination (r2) ≥ 0.99900
(UV-Vis) reference standard R/F precision ≤ 5.00 % RSD
Response Linearity 5 concentrations of certified Coefficient of determination (r2) ≥ 0.99500
(RID, CD) reference standard R/F precision ≤ 10.00 % RSD
Gradient Composition Accuracy 20.00 %, 40.00 %, 60.00 %, 80.00 % Accuracy ≤ 2.00 %
(UV-Vis) steps
Gradient Composition Noise and Drift 20.00 %, 40.00 %, 60.00 %, 80.00 % Composition noise ≤ 2.00 %
(UV-Vis) steps Composition drift ≤ 2.00 %
Gradient Composition Noise and Drift 20.00%, 40.00%, 60.00%, 80.00% Composition noise ≤ 3.50 %
(CD) steps Composition drift ≤ 3.50 %
Gradient Composition Linearity Linear gradient from 100 % to 0 % Coefficient of determination (r2) ≥ 0.99900**
(UV-Vis, CD) (at start, 50:50 zone, end)
Sample Temperature Temperature = 4.0 °C Diff. from setpoint ≥ –2.0 °C, ≤ 5.0 °C (setpoints < 10 °C)
Accuracy Samples four vials of water in
different tray positions
Fraction Collection Select Fraction Collector 1, 2, or 3 Peak Presence (Qualitative)
Select Peak or Time-based
collection mode
* r2 ≥ 0.99000 for CD
Key:
Fixed setpoints/limits Variance allowed for setpoint(s)
For multiple-detector systems, only one execution of the Injection Precision & Carry-Over tests will be performed in the standard
test program – by default using the UV detector if present. Repeat execution of the test can be added as optional tests for a
nominal fee

Standard OQ Test Specifications for Analytical-Scale LCMS Systems: Single Quadrupole

Vacuum Verification N/A High vacuum min.: 2E-6 torr (any source)
High vacuum max.: 2E-5 torr (any source)
Scan Verification See table below for used masses. All used masses: ± 0.2 m/z (ES, CI, MMCI; N/A for MMES, PI)
Response Linearity Evaluated mass: 311 m/z Coefficient of determination (r2): ≥ 0.98000 (any source)
Injection volume on volumn: 5 ul*
Injection Precision Evaluated mass: 311 m/z Area RSD: ≤ 10.00 % (any source)
Injection volume on volumn: 5 ul* Height RSD: 10.00 % (any source)
Injection Carry Over Evaluated mass: 311 m/z Area carry over ≤ 1.00 % (any source)
Injection volume on volumn: 5 ul* Height carry over ≤ 1.00 % (any source)
Signal to Noise Evaluated mass: 311 m/z Signal to noise: ≥ 20 (any source)
Injection volume on volumn: 5 ul*
* 1 ul for 6150B Series AP-ESI source with Agilent Jet Stream Technology
Key:
ES (API-ES) / CI (AP-CI) / MMES (Multimode API-ES mode) / MMCI (Multimode AP-CI mode) / ES+AJST (AP-ESI with
Agilent Jet Stream Technology) / PI (AP-PI)
Masses for Scan Verification
Known G2421A AP-ESI (G6110A, G2423A AP-CI (G6110A, G1969-85000 ESI-L, AP-ESI G1969-85010 APCI-L AP-CI
Mass G6120A/B, G6130A/B** G6120A/B, G6130A/B), & MM Source (G6140), (G6140A, G6150B), AP-PI
AP-PI ES+AJST (6150B)
1. 118.09 121.05 118.09 121.05
2. 622.03 622.03 622.03 622.03
3. 922.01 922.01 922.01 922.01
4. 1521.97* 1521.97* 1221.99 1221.99
5. 2121.93* 2121.93* N/A N/A
* Applies to SL and 6130 systems only.
** Also applies to G1946C, G1946D, G1956A, and G1956B models.

Standard OQ Test Specifications for Analytical-Scale LCMS Systems: Triple Quadrupole

Vacuum Verification N/A High vacuum min./max.(any source):
6410/6410-2K: 2.7E-5 torr/3.4E-5 torr (w/out HotBox)
6410/6410-2K: 1.8E-5 torr/2.7E-5 torr (with Hotbox)
6430A/6460A: 1.5E-5 torr/2.7E-5 torr
6490: 4.45E-4 torr/6.0E-5 torr
6420: 2.5E-5 torr / 3.5E-5 torr
Scan Verification See table below for used masses. All used masses: ± 0.2 m/z (ES only; N/A for others)
Scan Verification See table below for used masses. All used masses: ± 0.2 m/z (ES only; N/A for others)
(Additional Filter)
Response Linearity Evaluated mass: 156 m/z Coefficient of determination (r2): ≥ 0.98000 (any source)
Injection volume on column: 5 ul*
Injection volume on column: 5 ul* Height RSD: N/A (any source)
Injection Carry Over Evaluated mass: 156 m/z Area carry over ≤ 1.00 % (any source)
Injection volume on column: 5 ul* Height carry over ≤ 1.00 % (any source)
Signal to Noise Evaluated mass: 156 m/z Signal to noise: ≥ 20 (ES, MMES, MMCI; N/A for CI)
Injection volume on column: 5 ul* For 6490A with Agilent Jet Stream: ≥ 1,000
* 1 ul for 6460A Series AP-ESI source with Agilent Jet Stream Technology
* 0.5 ul for the 6490A with Agilent Jet Stream Technology
Key: Fixed setpoints/limits Variance allowed for setpoint(s)
ES (API-ES) / CI (AP-CI) / MMES (Multimode API-ES mode) / MMCI (Multimode AP-CI mode) / ES+AJST (AP-ESI with
Agilent Jet Stream Technology)
Masses for Scan Verification, Scan Verification (Additional Filter)
Known 6410A-2K, 6420A,

Mass 6410A G6410B 6460A* 6430A* 6490A
ESI-L MMI-L ESI-L MMI-L ESI-L MMI-L ESI-L MMI-L ESI-L
1. 118.09 121.05 118.09 121.05 118.1 121.1 118.1 121.1 118.09
2. 322.05 322.05 322.05 322.05 322.1 322.1 322.0 322.0 322.05
3. 622.03 622.03 622.03 622.03 622.0 622.0 622.0 622.0 622.03
4. 922.01 922.01 922.01 922.01 922.0 922.0 922.0 922.0 922.01
5. 1221.99 1221.99 1221.99 1221.99 1522.0 1522.0 1222.0 1222.0 1221.99
6. 1521.97 1521.97 1821.95 1821.95 2121.9 2121.9 1822.0 1822.0 n/a
ESI-L P/N is G1969-85000; MMI-L P/N is G1969-85020.
* Reported known masses values may show 2 decimal digits depending on the acquisition software used.

Standard OQ Test Specifications for Analytical-Scale LCMS Systems: Ion Trap

Scan Verification See table below for used masses. All used masses: ± 0.2 m/z (ES only, N/A for others)
Response Linearity Eval. mass: 156/218/245 m/z* Coefficient of determination (r2): ≥ 0.98000 (any source)
Injection volume on column: 5 ul**
Injection Precision Eval. mass: 156/218/245 m/z* Area RSD: ≤ 10.00 % (any source)
Injection volume on column: 5 ul** Height RSD: N/A (any source)
Injection Carry Over Eval. mass: 156/218/245 m/z* Area carry over ≤ 1.00 % (any source)
Injection volume on column: 5 ul** Height carry over ≤ 1.00 % (any source)
* Use the most abundant ion.
** For CI source, use 20 ul.
Key:
ES (API-ES) / CI (AP-CI) / MMES (Multimode API-ES mode) / MMCI (Multimode AP-CI mode)
Known Mass G2431A Ion Trap ESI Tune Mix

1. 118.09
2. 322.05
3. 622.03
4. 922.01
5. 1521.97
6. 2121.93

Standard OQ Test Specifications for Analytical-Scale LCMS Systems: Q-TOF

High vacuum max.: 4E-5 torr (any source),
(5.5E-5 torr for 6538/6540/6550)
(Additional Zone) High vacuum max.: 6E-7 torr (any source)
Scan Verification See table below for used masses. All used masses: ± 0.2 m/z (DSES, ES+AJST; N/A for others)
Scan Verification See table below for used masses. All used masses: ± 3.0 ppm (DSES, ES+AJST; N/A for others)
(Additional Filter)
Response Linearity Evaluated mass: 156 m/z Coefficient of determination (r2): ≥ 0.98000 (DSES, ES+AJST;
Injection volume on column: 20 ul* N/A for others)
Injection volume on column: 20 ul* Height RSD: Not applicable (any source)
Injection Carry Over Evaluated mass: 156 m/z Area & height carry over ≤ 1.00 % (DSES, ES+AJST;
Signal to Noise Evaluated mass: 156 m/z Signal to noise: ≥ 10 (DSES, ES+AJST; N/A for others)
* 10 ul for 6530 & 6540 Series AP-ESI source with Agilent Jet Stream Technology). 1 ul for 6550 Series with AP-ESI source with Agilent Jet Stream Technology.
Key:
ES (API-ES) / CI (AP-CI) / MMES (Multimode API-ES mode) / MMCI (Multimode AP-CI mode) / DSES (Dual spray API-ES) /
ES+AJST (AP-ESI with Agilent Jet Stream Technology)
Masses for Scan Verification, Scan Verification (Additional Filter): ESI-L P/N G1969-85000
Known Mass First Filter Additional Filter

1. 118.09 118.086255
2. 322.05 322.048121
3. 622.03 622.028960
4. 922.01 922.009798
5. 1221.99 1221.990637
6. 1521.97 1521.971475
7. 1821.95 1821.952313
8. 2121.93 2121.933152
9. 2421.92 2421.913990
10. 2721.90 2721.894829

Standard OQ Test Specifications for Analytical-Scale LCMS Systems: TOF

Scan Verification See table below for used masses. All used masses: ± 3.0 ppm (CI, MMCI, DSES, ES+AJST; N/A
for MMES)
Response Linearity Evaluated mass: 311.08 m/z Coefficient of determination (r2): ≥ 0.98000 (DSES, ES+AJST;
Injection Precision Evaluated mass: 311.08 m/z Area RSD: ≤ 10.00 % (any source)
Injection volume on column: 20 ul* Height RSD: N/A (any source)
Injection Carry Over Evaluated mass: 311.08 m/z Area & height carry over ≤ 1.00 % (DSES, ES+AJST; N/A for
Injection volume on column: 20 ul* others)
Signal to Noise Evaluated mass: 311.08 m/z Signal to noise: ≥ 20 (DSES, ES+AJST; N/A for others)
* 10 ul for 6230 Series AP-ESI Source with Agilent Jet Stream Technology
Key:
ES (API-ES) / CI (AP-CI) / MMES (Multimode API-ES mode) / MMCI (Multimode AP-CI mode) / DSES (Dual spray API-ES) /
ES+AJST (AP-ESI with Agilent Jet Stream Technology)
Known Mass G1969-85000 ESI-L Tune Mix G1969-85020 MMI-L Tune Mix G1969-85010 APCI-L Tune Mix
1. 118.086255 121.050873 121.050873
2. 322.048121 322.048121 322.048121
3. 622.028960 622.028960 622.028960
4. 922.009798 922.009798 922.009798
5. 1221.990637 1221.990637 1221.990637
6. 1521.971475 1521.971475 1521.971475
7. 1821.952313 1821.952313 1821.952313
8. 2121.933152 2121.933152 2121.933152
9. 2421.913990 2421.913990 N/A
10. 2721.894829 2721.894829 N/A
End of Section – Standard OQ Test Specifications for Agilent Analytical Scale LCMS Systems

OQ Test Design and Rationale for Analytical Scale LCMS Systems
Many GMP/GLP enforcement agency inspectors now ask firms to provide a risk assessment of their equipment and computer
systems plus a science-based rationale for subsequent validation and qualification testing.
GENERAL RISK STATEMENT: Any HPLC, LCMS, UHPLC, UHPLC_MS, GC, or GCMS system used for raw material testing or final
drug product / medical device testing in GMP or used in formal GLP studies will likely fall into a HIGH RISK category. This risk
assessment will imply the need for IQ & OQ & on-going qualification. ANY USER SPECIFIC RISK ANALYSIS SUPERCEDES THIS
GENERAL RISK STATEMENT.
The rest of this section outlines the science-based rationale for each test in the Agilent hardware OQ plus a brief test design
and procedure description.
The recommended set of hardware OQ tests described in this EQP derives from Agilent’s intepretation of FDA, USP, and GAMP4
guidelines and other authoritative expert literature.
OQ test design incorporates both modular and holistic testing, which is a proven and regulatory acceptable approach. Direct
metrology is used to test pump flow rates and thermal-controlled column compartment and autosampler modules. Holistic
chemical testing is used for the evaluation of the following critical instrument characteristics: linearity, precision, signal to noise,
and carry over.
Certified reference standards and calibrated traceable thermometers and digital flowmeters are used.
Considering the number of setpoints, parameters, and conditions of each recommended OQ test, the proven concepts of worst
case, range, and representative have been applied. If a property or characteristic is known to have its worst performance
at one end of a range of use, this is the setpoint that should be tested and other setpoints are not required. If a property or
characteristic has no known worst case, testing at the high and low points of the range of use is required. If there are too many
possible use cases and conditions to realistically test (and none is a worst case), a representative sample for test is the best
approach.
The test design for HPLC systems covers UV absorbance, fluorescence, evaporative light scattering, refractive index, and
conductivity detectors; isocratic, binary, tertiary, and quaternary pumps; most autosampler models; and fraction collectors.
Tests for HPLC Systems (Non-MSD)
1. Pump Flow Accuracy and Precision
Rationale: Accuracy of flow is important for comparability between systems and transferring methods. Flow precision is critical
for repeatability of peak height and area.
Procedure: A calibrated digital flowmeter is attached to the waste line of the system flowing pure water at representative
back pressure provided by a small guard column. Six readings are taken at each setpoint to determine the flow accuracy
and precision. Flow accuracy is calculated as the absolute % difference of the mean of the six flow readings against the
setpoint. The precision is calculated as the %RSD of the six flow readings. The two default setpoints (0.5ml/min and 5.0 ml/
min) are evaluated in the core test. Extra setpoints and flexible test range are only available in customer-configured EQPs for
flow, temperature, and some other tests. The repeat measurements of flow in the flow precision test eliminate the need for
measurement of retention time precision (which is an indirect approach to determining flow precision).

OQ Test Design and Rationale for Analytical Scale LCMS Systems (continued)
2. Column Temperature Accuracy and Stability
Rationale: The thermostat accuracy is important for comparability between systems and transferring methods. Column
temperature stability is critical for repeatability of peak height and area.
Procedure: A calibrated digital temperature meter and a proprietary probe are used to measure the temperature of the flowing
eluent. With the use of a T-piece, the temperature probe is positioned to be in contact with the heated eluent. A typical column
compartment temperature range of use is tested. At the high end of the range, after stabilization, the temperature accuracy is
calculated as the absolute difference between what was measured and the setpoint. After completing this measurement at the
low end of the range, six readings are taken every four minutes and temperature stability is calculated as the absolute difference
between the highest and lowest measured temperatures. The temperature accuracy is calculated as the average of the six
readings compared to the setpoint. All readings are reported in Celsius. Both sides of the Agilent column compartment are
tested at the same time.
3. Wavelength Accuracy
Rationale: Wavelength accuracy is critical for accuracy of quantitative and qualitative analysis. Wavelength accuracy is also
important for comparability between systems and transferring methods.
Procedure for UV absorbance detector (UV, VWD, DAD, PDA, etc.): A traceable caffeine standard is used to determine the
wavelength accuracy. In one procedure, for certain models, the caffeine is trapped in the flow cell and a programmable timetable
is used to determine the wavelength maxima (205 and 273 nm) and minimum (245 nm). For other models (for example, DAD and
PDA), a caffeine injection is made and a spectrum is acquired. The spectral maxima and minimum are determined directly from
the scan or the table of scan results. The wavelength accuracy is determined as the absolute difference between the measured
and certified wavelength values.
Procedure for fluorescence detector: The detector cell is filled with pure water. Using a programmable timetable, the excitation
(350 nm) and Raman band emission (397 nm) wavelengths are determined. The wavelength accuracy is determined as the
absolute difference between the measured and theoretical peaks of Raman scattering (in nm).
4. Signal Noise and Drift
Rationale: This test gives an indication of detector sensitivity and stability.
Procedure for UV absorbance detectors: Pumping water at 1 ml/min, the signal is monitored at a specified wavelength over a
twenty minute period. The signal noise is calculated based on ASTM E685-93 as the average peak-to-peak noise in a number of
signal segments. The drift is calculated as the slope of the linear regression for the signal.
Procedure for evaporative light scattering detectors: With no flow and the inlet to the detector capped, the signal is monitored
over a twenty minute period. The signal noise is calculated based on ASTM E685-93 as the average peak-to-peak noise in a
number of signal segments. The drift is calculated as the slope of the linear regression for the signal.
Procedure for refractive index detectors: Pumping water at 1 ml/min, the signal is monitored over a twenty minute period. The
signal noise is calculated based on ASTM E685-93 as the average peak-to-peak noise in a number of signal segments. The drift
is calculated as the slope of the linear regression for the signal.
5. Injection Precision
Rationale: System precision is critical for accuracy of quantitation. Autosampler performance contributes to system precision.
Procedure: A short column is used to separate the evaluation standard from the void volume. Using a traceable standard, six
injections from the same standard are made and the height, area, average height, average area, %RSD of height and %RSD of
area are determined and calculated.

6. Injection Carry Over
Rationale: Low carry over from a previous injection is critical for accuracy of quantitative and reliability of qualitative analysis.
This test challenges the injector system in the HPLC system.
Procedure: Following the six-injection precision test, a blank injection is made. The carry over result is calculated as a ratio of
the area of any residual peak found in the blank injection to the area of the previous injection (expressed as a percentage).
7. Signal to Noise
Rationale: Sensitivity is a critical performance feature in quantitative and qualitative analysis. A signal-to-noise value of a
representative compound at known concentration provides sensitivity statistics. This measurement is especially critical to
establish level of detection.
Procedure for UV absorbance detector and refractive index detector: An evaluation standard is injected and the calculated
height, divided by the ASTM noise monitored over a specified range, provides the signal-to-noise result. Procedure for
fluorescence detector: Using pure water in the flow cell, the signal is monitored at the emission maximum wavelength of the
Raman band of water and then, using a timetable, switched to a no emission wavelength where the noise is monitored. Signal
to noise is calculated as the height of the Raman band peak divided by the monitored noise in a spectral region where no
scattering is expected.
8. Response Linearity
Rationale: The linearity of a detector is a critical parameter to establish for reliable and accurate quantitative results and is
important for comparability between systems and transferring methods.
Procedure: A series of five traceable standards which represent typical concentrations range are injected and evaluated. The
response linearity is calculated by determining the coefficient of determination (r2) of the peak areas versus concentration. It is
now recognized that regression statistics alone are insufficient and non-sensitive indicators of linearity. Therefore, the % RSD of
the response factors for all five peaks is also calculated. In addtion, as an optional extra linearity statistic, ratios of peak areas
in the set of five injections can be reported. For example, up to two ratios such as Peak 2 to Peak 1 and Peak 5 to Peak 2 can be
selected in the EQP Record of Variances section.
9. Gradient Composition
Rationale: Accuracy and stability of solvent mixing online is critical for consistent and accurate quantitative analysis. Gradient
composition is also important for comparability between systems and transferring methods.
Procedure: [Pre-requisite: UV detector is installed.] An acetone tracer is used to determine the solvent gradient composition
accuracy, stability, and linearity. The test challenges the system by making compositional changes from 0 % to 100 % in 20 %
increments. In addition, a linear ramp down from 100 % to 0 % is performed where the composition linearity is determined
between ranges 95, 75, and 25 %. All composition accuracies are calculated as the absolute difference between the mean
composition at each setpoint and the theoretical composition. Stability is determined by the noise and drift at each composition
step. Linearity is calculated from 95 % to 5 % in the linear portion of the gradient.
10. Sample Temperature Accuracy
Rationale: The thermostat accuracy is important for comparing systems and transfer methods.
Procedure: Four vials are filled with water and allowed to equilibrate to the temperature setpoint. Similar to the column
compartment, the temperature of the water is measured using a traceable digital temperature meter and proprietary probe.
Accuracy is determined as the difference between the measured temperature and the setpoint.

11. Fraction Collection (only applicable if collector is installed)
Rationale: It is important to demonstrate that a fraction collector can collect fractions based on peak detection or time.
Procedure: Two injections of a traceable standard are made and fractions are collected in peak-based or time-based mode. This
is a qualitative test in which collected fractions are re-injected to prove that they are fractions of the traceable standard.
Tests for Mass Spectrometer Detectors of LCMS:
MSD 1. Vacuum Verification
Rationale: A stable, high vacuum is required for high-sensitivity mass spectrometry.
Procedure: Multiple readings of the vacuum system are taken and an automated comparison of these values to the known
acceptable values is made. Passing this test is a pre-requisite for the following tests.
MSD 2. Scan Verification
Rationale: Calibration of mass range is critical in qualitative mass spectrometry.
Procedure: [Agilent LCMS] The built-in Agilent autotune is performed to determine the proper calibration of the MSD and ensure
that masses are correctly reported across the entire mass range of the instrument. [Non-Agilent LCMS] A manual tune is made
where applicable.
MSD 3. Response Linearity
Rationale: Knowledge of the response curve is critical for quantitative analysis.
Procedure: A sulfa drug mix standard of four sulfonamide drugs is injected into the system at five concentrations representing
a wide range for LCMS. The ions monitored are appropriate to the system type. The calculated RSQ best-fit regression line and
plot of the response curve provides the statistics required to evaluate the instrument’s overall response curve. This allows users
to set appropriate calibration ranges and limits in their quantitative application methods.
MSD 4. Injection Precision
Rationale: System precision is critical for accuracy of quantitation. Autosampler performance and MS ionization contribute to
LCMS system precision. Autosampler precision is challenged in the standard LC module tests using a UV detector. A repeat
precision test in MS mode further challenges the precision of source ionization and MS detection. Procedure: A blank injection
followed by six repeat injections of the sulfa drug mix followed by a final blank injection are made. The %RSD of the six
injections is calculated to provide precision statistics.
MSD 5. Carry Over
Rationale: Low carry over from a previous injection is critical for accuracy of quantitative and reliability of qualitative analysis.
Autosampler performance and MSD condition contribute to LCMS carry over. Autosampler carry over is challenged in the
standard LC module tests using a UV detector. A repeat carry over test in MS mode further challenges the full LCMS system
carry over performance.
Procedure: A blank injection followed by single injection of the highest concentration standard followed by a blank injection. The
last blank injection is evaluated for carry over and the result expressed as a percentage of the value for the standard injection.

MSD 6. Signal to Noise
Rationale: Sensitivity of MS detection is an important performance feature in quantitative and qualitative analysis. A signal-to-noise value
of representative compounds and appropriate ions at known concentration provides sensitivity statistics.
Procedure: For all newly installed Agilent LCMS systems, a reserpine chemical standard is injected as part of the instrument checkout test
to provide a starting sensitivity reading. The reserpine signal-to-noise result is provided separately to the OQ report but can be attached to
the OQ report if required. For OQ at installation and ongoing OQ/recalibration, the signal-to-noise value of the sulfa drug mix is reported at
the ion of interest. System performance over time can be evaluated by repeating this OQ test at suitable intervals. (Signal to noise is only
evaluated using the AP-ESI source except for single quad. Ion Trap does not have signal to noise OQ test).
The following tests are NOT INCLUDED in the standard OQ for LCMS but can be ordered as EXTRA COST TESTS.
Test Name Setpoints and Parameters Limits Include

Injection Linearity (UV-Vis) Any choice of 5 injection volumes. Coefficient of determination (r2) ≥ 0.99900
Constant concentration standard is R/F precision ≤ 5.00 % RSD
5 ug/ml caffeine.
Injection Response Same setpoint as Injection Average area ≥ 1,200,000 and ≤ 1,800,000 counts
(UV-Vis) Precision test. (For standard cell with 20 ul injection. Result is
corrected for path length and attenuation.)
Wavelength Accuracy Wavelength 1 = 361 nm [Maximum] Accuracy ≤ 2 nm
(Extended Test, UV-Vis) Wavelength 2 = 416 nm [Maximum]
Additional Test 1. Injection Linearity (optional extra test available in custom-configured EQP)
Rationale: Injection linearity of variable volume HPLC injector systems is normally not critical to quantitative or qualitative analysis. Most
HPLC analytical methods use fixed and only nominal injection volumes and do not use variable volume injections within a single analysis.
However, some users may wish to use variable volume injection if the linearity is demonstrated.
Procedure: Five injections of increasing volumes of the same traceable caffeine standard are made. Injection linearity is calculated
from the coefficient of determination (r2) of the peak areas versus injection volume. Also, %RSD of the response factor for all five peaks
is calculated.
Additional Test 2. Injection Response (optional extra test available in custom-configured EQP)
Rationale: The accuracy of the injected volume is normally not critical to quantitative or qualitative analysis. Most HPLC analytical
methods use fixed and only nominal injection volumes and results are not affected by even moderate inaccuracy in actual injected volume.
However, it may be important for comparability between systems and transferring methods, and it is useful as a diagnostic for establishing
that the correct injection syringe/loop/device is installed.
Procedure: A known traceable caffeine standard is injected six times (in the precision tests) and the average response is calculated.
The injection response is the mean of the average areas corrected for sample concentration, cell path length, and attenuation, and the
response within an acceptance window indicates correct volume injected.
Additional Test 3. Wavelength Accuracy, Extended Test: (optional extra test available in custom-configured EQP)
Rationale: Wavelength accuracy is critical for accuracy of quantitative and qualitative analysis. Wavelength accuracy is also important for
comparability between systems and transferring methods.
Procedure for UV absorbance detector (UV, VWD, DAD, PDA, etc.): A traceable holmium oxide standard is used to determine the
wavelength accuracy. In one procedure, for certain models, the holmium oxide is trapped in the flow cell and a programmable timetable
is used to determine the wavelength maxima (241, 278, 287, 361, 416, 451, 537 and/or 641 nm). For other models (for example, DAD and
PDA), a holmium oxide injection is made and a spectrum is acquired. The spectral maxima are determined directly from the scan or
the table of scan results. The wavelength accuracy is determined as the absolute difference between the measured and certified
wavelength values.

EQP Record of Variances to Setpoints from Standard OQ Specifications
IGNORE THIS SECTION IF YOU ACCEPT AND APPROVE THE FIXED STANDARD QUALIFICATION TESTS AND SETPOINTS RECORDED IN
THE PRECEDING PAGES OF THIS STANDARD EQP.
EQP with Variance Approval Process: Customer Actions:

1. View in Adobe ®; select required setpoint variances below; select the alternative approval statement on page 2.
2. Print to paper to save the selections; sign page 2 of this EQP.
3. Ensure the approved EQP with Variances is provided to Agilent operator on the day of the first delivery before start of OQ. Counter-sign
and date the Agilent operator signature on this page. [End of EQP with Variance approval process. Next step: wait for your qualification
reports.]. Agilent Operator Actions:
1. Enter and save the customer change requests on this page into the ACE tool.
2. Sign and date this page on the customer copy to verify that you made the changes in ACE; return signed copy to customer for
counter-signature.
3. Deliver the qualification by following this EQP and any setpoint variances. (Note: Once the EQP Variances are entered into
ACE these are saved for all future OQ/RQ events where applicable.)
Test Name Setpoint Standard Variance Units

Pump Flow Accuracy and Precision Flow Rate 1 0.500 No variance ml/minute
Flow Rate 2 5.000 No variance ml/minute
Column Temperature Accuracy and Stability Temperature 1 80.0 No variance °C
Temperature 2 40.0 No variance °C
Injection Precision, Carry Over (UV-Vis, RID) Injection Vol. on Column 20 No variance ul
Injection Precision, Carry Over (CD) Injection Vol. on Column 25 No variance ul
Injection Precision (ELSD) Injection Vol. on Column 20 No variance ul
Sample Temperature Accuracy Temperature 4.0 No variance °C
Response Linearity (UV-Vis, RID optional extra 1st Peak Area Ratio Not applicable No variance
statistic) 2nd Peak Area Ratio Not applicable No variance
Wavelength Accuracy (Extended Test, UV-Vis) Wavelength 1 361 No variance nm
Wavelength 2 416 No variance nm
Injection Linearity Injection Volume 1 Not applicable ul
Injection Volume 2 Not applicable ul
injection Volume 3 Not applicable ul
Injection Response injection Volume Not applicable ul
Customer: Agilent Operator (verifies variances are entered into ACE):

Name: Name:
Signature, Date: Signature, Date:
For a fully tailored operational qualification program using all the flexibility of Enterprise Edition, contact your local Agilent representative and/or e-mail Enterprise_edition@agilent.com
with your OQ test specification requirements. Fees may apply.
Re-Qualification after Repair (RQ) Hardware

In the event of a hardware breakdown followed by an engineering repair of a qualified instrument, it is necessary to re-qualify
the system to an appropriate level before release back into operational use.
Agilent offers a service contract to repair and re-qualify an instrument during the period between scheduled annual OQs.
The level of re-testing is prescribed in the RQ section of ACE: a form is displayed for the operator showing all types of repair
possible and the re-testing required. Part of an example form is shown below.
Re-Qualification After Repair

Pump Strategies
Repair/Replace Strategy Modules OQ/PV Testing
Internal pump head parts, active inlet valve (or AIV cartridge), (parts of) check Any pump Flow Accuracy & Precision
valves, reference valves, inlet manifold or pump drive, or taking pump head
apart to clean (versus repair)
Pulse damper, pressure transducer Any pump Flow Accuracy & Precision
Multi-channel gradient valve Quaternary Flow Accuracy & Precision
Gradient Composition
The full list of repair and re-test guidance is available for review by customers of the RQ service.
The RQ form in ACE prescribes which tests the operator must perform for each repair circumstance. The test procedure,
setpoints, and limits will be an exact repeat of the previous OQ test (a so called regression testing strategy).
Dual-Acceptance Limits
Within the Equipment Qualification Plan (EQP) of the Agilent Enterprise Edition, each of the tests final result can be compared
against two different limits if required. This allows customer-configured OQ to report against a User Limit (limit1) and the Agilent
Recommended Limit (limit2) simultaneously.
The Standard_EQP documents have both Limit1 & Limit2 values set the same – effectively de-activating this feature. Custom_
EQP’s can also be prepared on request, making effective use of the Two-Limit feature of the Agilent Compliance Engine (ACE).
In those cases, “Limit2” will always be the Agilent Recommended limit, and “Limit1” will be the limit requested by the user.
Agilent will not be under any obligation regarding the OQ testing results against User-requested limits that are more stringent
than the Agilent Recommended ones.
Legal, Endorsement, and Revision History

Enterprise Edition and its primary components (ACE software tool, procedures, test design, metrology tools, chemical reference
standards, operator training materials) has been designed, developed, tested, validated, and released for commercial use
following Agilent’s Life-Cycle Development Quality Assurance methodology.
Date: April 2014
Services R&D Manager: Michael F. Pope. Santa Clara, California USA
Services Quality Manager: Julio Hector. Santa Clara, California USA
Enterprise Edition is endorsed by Dr. Ludwig Huber on behalf of labcompliance.com.
ACE software is patented. Copyright is claimed by this statement for all original work comprising Enterprise Edition. Any
unauthorized use, reproduction, or translation will be prosecuted to the maximum extent possible by law. All customer copies of
EQP approval, final qualification reports, and raw data provided to customer at delivery of the service become the property of
the customer.
Revision History of LCMS Enterprise Edition Protocols.

A.01.84 April 2014 Injection Precision MS Negative Mode: new test for Agilent 6400 Series QQQs with AJST or standalone AP-
ESI sources.
Injection Carryover test: fixed issue in calculations if no carryover can be detected.
A.01.83 September 2013 (1) Changed injection volume in the Carry-Over test to 25ul and to 5ul for CD and FLD systems respectively.
(2) Agilent G6460B model number changed to G6460C.
A.01.82 April 2013 Added support for (1) Agilent G6460B QQQ; (2) G4260A/B and G4621 A/B ELSD Detectors (former Varian
380, 385); (3) Agilent G4234B column switching valve.- Removed need for specific source in all tests on
G6540B QTOF. No regulatory impact for previously approved EQP’s.
A.01.81. December 2012 Added support for (1) G6230B TOF, (2) G6530B/G6540B QTOF, (3) G1959B Dual-Spray Agilent Jet Stream.
Updated Vacuum verification, Scan verification for Waters MSDs. Corrected TOF/Q-TOF Injection volume on
Column setpoint for API-CI or MM source to 20 ul – Injection Carry Over test.
A.01.80. July 2012 Added support for: (1) Agilent G4204A 1290 quaternary pump; (2) Option 200 on Agilent G6540A Q-TOF.
Auto-detection of expected masses from tune report in Scan Verification test (TOF, Q-TOF, QQQ).
A.01.79. April 2012 Added support for Agilent G6550A Series Q-TOF Systems. Changed quad limits for Vacuum Verification for
G6540A and G6538A Q-TOF systems.
A.01.78. February 2012 Added support for Agilent APPI source on Single-Quad systems. Corrected masses for negative scan type for
APCI sources on G6150B. No Regulatory impact for previously approved EQP documents.
A.01.77. December 2011 Added support for Agilent G6420A QQQ. No regulatory impact for previously approved Standard_EQP
documents.
A.01.76. August 2011 No changes to LCMS. Protocol revision made independent from ACE revisions. No regulatory impact for
previously-approved Standard_EQP documents.
A.01.75. March 2011 (1) Added support for Agilent 6490A QQQ. No regulatory impact for previously-approved Standard_EQP
documents.
A.01.74. September 2010 (1) Added support for Agilent 1220 & 1260 Infinity Systems. (2) Added FLD tests for Injection Precision &
Carry Over. (3) Added Tests definitions for non-Agilent Systems. No regulatory impact for previously-approved
Standard_EQP documents.
A.01.73. July 2010 (1) Added Additional Tests Selection Boxes. (2) Added Additional Tests Variances tables. No regulatory impact.
A.01.72. January 2010 Signal to Noise (MSD only): switched from ASTM noise to rms noise calculation. (NO REGULATORY IMPACT)
A.01.71. October 2009 (1) Added Agilent QQQ G6430A support; (2) added E-signature fields; (3) changed nomenclature used to list
limits (NO REGULATORY IMPACT).
A.01.70. May 2009 (1) Added multi-probe source support; (2) added Agilent 6200 Series LCMSs/TOFs (G6224A, G6230A);
(3) added Applied biosystems mass spec support (API 150/3000/4000).
Revision History (continued)
Revision History of LCMS Enterprise Edition Protocols.

A.01.60. May 2008 No changes for LCMS.
A.01.53. August 2007 Added Q-TOF support.
A.01.50. March 2007 Added LCMS-MS support.
A.01.40. December 2006 Added initial LCMS support.
A.01.30. July 2006 (No LCMS support.)
A.01.20. March 2006 (No LCMS support.)
A.01.10. November 2005 Initial HPLC - Analytical Scale - Operational Qualification (no LCMS support).
End of EQP Review Document
www.agilent.com/chem/enterprise
Information, descriptions and specifications in this
publication are subject to change without notice.
© Agilent Technologies, Inc. 2014

Published in USA, April 22, 2014
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EQUIPMENT QUALIFICATION PLAN

Agilent Enterprise Edition Compliance Services

Qualification of Analytical Scale LCMS Systems

REVIEW DOCUMENT NAME:

How to Use This Document

Name and Role Signature and Date

How Enterprise Edition Compliance Services Work.................................................................................................. 4

Design Qualification (DQ)............................................................................................................................................... 5

Installation Qualification (IQ) Hardware...................................................................................................................... 6

Operational Qualification (OQ) Hardware.................................................................................................................... 7

Standard OQ Test Specifications for Analytical-Scale LCMS Systems:

OQ Test Design and Rationale for Analytical Scale LCMS Systems.............................................................................. 14

EQP Record of Variances to Setpoints from Standard OQ Specifications..................................................................... 19

Re-Qualification after Repair (RQ) Hardware............................................................................................................ 20

Legal, Endorsement, and Revision History................................................................................................................ 21

Why Has Agilent Introduced the New

EE 1.76 Comparison Part 11 Checklist (ACE) Q & A: Why Change?

How Enterprise Edition Compliance Services Work

Design Qualification (DQ)

Installation Qualification (IQ) Hardware

Operational Qualification (OQ) Hardware

Test Name Setpoints and Parameters Limits

Key: Fixed setpoints/limits Variance allowed for setpoint(s)

Operational Qualification (OQ) Hardware (continued)

Test Name Setpoints and Parameters Limits

Operational Qualification (OQ) Hardware (continued)

Test Name Setpoints and Parameters Limits

Masses for Scan Verification

* Applies to SL and 6130 systems only.

** Also applies to G1946C, G1946D, G1956A, and G1956B models.

Operational Qualification (OQ) Hardware (continued)

Test Name Setpoints and Parameters Limits

* 0.5 ul for the 6490A with Agilent Jet Stream Technology

Key: Fixed setpoints/limits Variance allowed for setpoint(s)

Masses for Scan Verification, Scan Verification (Additional Filter)

Known 6410A-2K, 6420A,

Operational Qualification (OQ) Hardware (continued)

Test Name Setpoints and Parameters Limits

** For CI source, use 20 ul.

Masses for Scan Verification

Known Mass G2431A Ion Trap ESI Tune Mix

Operational Qualification (OQ) Hardware

Test Name Setpoints and Parameters Limits

Known Mass First Filter Additional Filter

Operational Qualification (OQ) Hardware

Test Name Setpoints and Parameters Limits

Masses for Scan Verification

Operational Qualification (OQ) Hardware

Operational Qualification (OQ) Hardware

Operational Qualification (OQ) Hardware (continued)

Operational Qualification (OQ) Hardware (continued)

Operational Qualification (OQ) Hardware (continued)

Test Name Setpoints and Parameters Limits Include

Fixed setpoints/limits Variance allowed for setpoint(s)

Operational Qualification (OQ) Hardware (continued)

EQP with Variance Approval Process: Customer Actions:

Test Name Setpoint Standard Variance Units

Customer: Agilent Operator (verifies variances are entered into ACE):

Re-Qualification after Repair (RQ) Hardware