安捷伦GC仪器安装运行确认Review Document_Standard_EQP_GC

EQUIPMENT QUALIFICATION PLAN (EQP)

Agilent Enterprise Edition Compliance Services

Qualification of GC Systems

Agilent 7890/7820 Series with Liquid or Headspace Samplers (Including CTC) and Agilent 6890/6850/5890 Models and Select Non-Agilent GC Models

REVIEW DOCUMENT NAME:

Agilent_Recommended_EQP_GC

Agilent_Recommended_EQP_GC ? Agilent Technologies, Inc. 2012Document Released: July 2012Enterprise Edition Compliance Services

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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 three 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 Comparion with previous versions.

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...

[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.

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Page 3 of 19Agilent_Recommended_EQP_GC ? Agilent Technologies, Inc. 2012Document Released: July 2012Enterprise Edition Compliance Services 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 GC Systems (7)

OQ Test Design and Rationale for GC Systems .......................................................................................................10 EQP Record of Variances to Setpoints from Standard OQ Specifications .. (16)

Re-Qualification after Repair (RQ) Hardware (17)

Legal, Endorsement, and Revision History (18)

PDF file attachments to this electronic EQP (open the attachments folder for this document in Adobe):

EE 1.76 Comparison Document Q & A: Why Change?

Part 11 Checklist (ACE)

Page 4 of 19Agilent_Recommended_EQP_GC ? Agilent Technologies, Inc. 2012Document Released: July 2012Enterprise Edition Compliance Services No reproduction, translation, or use without permission 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 GC 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 inpidual protocols for each chromatography system. This is the same concept for the EQP. The appropriate tests for each inpidual 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 GC 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 GC configurations plus a validated calculation and report generator engine. At time of delivery, a record of inpidual 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 inpidual GC 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.

Agilent_Recommended_EQP_GC ? Agilent Technologies, Inc. 2012Document Released: July 2012Enterprise Edition Compliance Services

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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.

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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.

.

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Operational Qualification (OQ) Hardware

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

* for 7697 HSS model only

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Operational Qualification (OQ) Hardware (continued)

Standard OQ Test Specifications for GC Systems (continued) Key: Fixed setpoints/limits Variance allowed for setpoint(s)

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Operational Qualification (OQ) Hardware (continued)

Standard OQ Test Specifications for GC Systems (continued)

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

End of Section - Standard OQ Test Specifications for Agilent GC Systems

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Operational Qualification (OQ) Hardware (continued)

OQ Test Design and Rationale for GC 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 LC, 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.

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.

The OQ test design incorporates modular and holistic testing which is a proven and regulatory acceptable approach. Direct metrology is used to test the inlet integrity (pressure decay and pressure accuracy), detector flow accuracy and temperature accuracy of the GC (oven, oven ramp, inlet/detector) and headspace heated zones. Holistic chemical testing is used for the evaluation of the following critical instrument characteristics: precision, signal to noise, and carry over. Certified reference standards and calibrated traceable thermometers and manometers 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, that end 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 following OQ tests for GC Systems (with FID, ECD, TCD, NPD, FPD, but NOT MSD) will be performed as appropriate for the configuration of the inpidual GC system.

1. System Inspection and Basic Safety and Operation [core GC OQ test]

Rationale: System must be in safe and operational condition before starting the OQ tests.

Procedure: The instrument is given a general inspection and its basic safety features are challenged to ensure proper operation.

2. GC Oven Temperature Accuracy and Stability [core GC OQ test]

Rationale: Oven temperature accuracy is important for comparability between systems and transferring methods. Oven temperature stability is critical for qualitative and quantitative analysis.

Procedure: At two different temperatures, accuracy is measured using an external calibrated thermometer. At one of these, five additional readings are taken at least four minutes apart to calculate the oven stability. Accuracy is the difference between found and setpoint values.

3. Headspace Vent and Pressurization Valve Integrity [core GC OQ test if headspace sampler is integral part of system] Rationale: Proper operation of the valves is critical for repeatable peak areas and carry over.

Procedure: This test verifies that the valves operate properly: with no excessive leaks or restricted internal flow paths.

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Operational Qualification (OQ) Hardware (continued)

OQ Test Design and Rationale for GC Systems (continued)

4. Headspace Heated Zones Temperature Accuracy [core GC OQ test if headspace sampler is integral part of system] Rationale: Temperature accuracy of the heated zones is important for comparing systems and transferring methods. Oven

accuracy is critical to quantitative headspace methods.

Procedure: The temperature is measured using an external calibrated thermometer with appropriate probe design. Accuracy is determined as the difference between found and setpoint values.

5. Inlet Pressure Decay [core GC OQ test]

Rationale: Pressure integrity of the inlet is critical for repeatable injection and retention times. The pressure decay and pressure accuracy tests combine to demonstrate pressure integrity.

Procedure: The inlet is capped, a pressure applied, and inlet flow is turned off. The pressure decay is recorded over a specified time range.

6. Inlet Pressure Accuracy [core GC OQ test]

Rationale: Pressure integrity of the inlet is critical for repeatable injection and retention times. The pressure decay and pressure accuracy tests combine to demonstrate pressure integrity. This test checks for accurate pressure to the head of the column. Column flow is achieved by maintaining a constant pressure against a known restriction. Because the restriction is a function of the column geometry, measuring pressure in the inlet is the most accurate way to determine flow.

Procedure: The inlet is capped, a pressure is applied and the inlet pressure is recorded using an external calibrated manometer connected to the inlet.

7. Detector Flow Accuracy [core GC OQ test]

Rationale: Detector flow accuracy is critical for a stable detector signal. Incorrect flows may have an impact on detector performance.

Procedure: Flow accuracy is determined by measuring the flows with a calibrated mass flowmeter and comparing them to the test setpoints and the values displayed by the GC.

8. Signal to Noise [core GC OQ test]

Rationale: Sensitivity of GC detection 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.

Procedure: A traceable standard is injected and signal to noise is calculated.

9. Injection Precision [core GC OQ test]

Rationale: System precision is critical for quantitative analysis.

Procedure: An initial stabilizing injection followed by six repeat injections of a traceable standard followed by a final blank injection is made. The %RSD of the six injections is calculated to provide precision statistics. There are separate dedicated instrument parameters and reference standards applicable to each inlet/detector combination. This test is performed with liquid and headspace sampler configurations.

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Operational Qualification (OQ) Hardware (continued)

OQ Test Design and Rationale for GC Systems (continued)

10. Carry Over [core OQ test for headspace but optional extra fee test for liquid samplers]

Rationale: Low carry over from a previous injection is critical for accuracy of quantitative and reliability of qualitative analysis. For headspace samplers, the engineering condition contributes to carry over performance, so this is a core OQ test for these samplers.

For liquid samplers, carry over performance is contingent on many variable factors independent of the engineering condition

of the GC system. Many different syringe wash programs are available that can eliminate carry over. These are user selectable and may be application specific. The condition of the injection syringe is the only controllable engineering factor. The injection syringe is typically replaced for new during PM before OQ. Therefore, the carry over test for liquid samplers is offered only as an optional extra fee test in a customer-configured EQP.

Procedure: The blank injection after the six repeat injections of the precision test is evaluated for carry over, and the result is expressed as a percentage.

11. Vial Heater Temperature Accuracy [core GC OQ test if sampler tray has the heater option installed]

Rationale: The 7693A vial heater option can be used during sample preparation. This test verifies that it heats accurately. Procedure: The temperature of the heater (using an external thermometer) is recorded and accuracy is calculated as the difference between the recorded value and setpoint. A single temperature is tested by default, but it is possible to add two more setpoints.

12. Signal Noise and Drift [core GC OQ test]

Rationale: This test gives an indication of detector sensitivity and stability.

Procedure: The signal is monitored at specified conditions appropriate to the type of detector over a twenty-minute period. The signal noise is calculated based on ASTM E594-96 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. Detector type and the gases used all contribute to different performance and therefore different limits for each configuration.

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Operational Qualification (OQ) Hardware (continued)

OQ Test Design and Rationale for GC Systems (continued)

The following tests are NOT INCLUDED in the standard OQ for GC but can be ordered as EXTRA COST TESTS.

Key:

Fixed setpoints/limits Variance allowed for setpoint(s)

Extra Test 1. FID Response Linearity [NOT CORE OQ TEST: additional extra fee test]

Rationale: Response linearity is critical for quantitative analysis. It is often demonstrated in user applications and analytical methods typically using multi-level calibration standards and internal standards. Therefore, this is an optional extra fee OQ test. The FID response linearity test uses a certified chemical reference test mix that is validated to be challenging and representative of many applications.

Procedure: The response linearity test is executed using a single injection from a standard containing a number of n-alkanes with increasing concentrations. Response linearity can be calculated with just one injection of a standard for the following reasons.

? The difference in length of the n-alkanes (boiling-point increases) separates these components on the column.

? The increasing concentration gives an increasing detector response.

? GC theory states (and experiment confirms) that the response factors for these compounds are the same (within a very small variance). Therefore, a single injection of this multi-component /multi-level concentration sample can be used to calculate the response linearity of the detector.

? The single injection test design eliminates the contribution of injector precision to the linearity statistics evaluation.

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Operational Qualification (OQ) Hardware (continued)

OQ Test Design and Rationale for GC Systems (continued)

Extra Test 2. GC Heated Zones Temperature Accuracy [NOT CORE OQ TEST: additional extra fee test]

Rationale: The precise temperature of the heated zones is not critical to quantitative or qualitative analysis. When the inlet zones are hot enough to vaporize but not so hot as to thermally decompose sample, this is adequate. When the detector zones are hot enough to evaporate sample and prevent condensation, this is adequate. Temperature accuracy of the heated zones may be important for comparing systems and transfer methods. Therefore, this is an optional test.

Procedure: This test demonstrates that the inlet and detector show an accurate temperature using proprietary novel design

to overcome the inherent difficulties in gaining accurate and meaningful readings. The temperature is measured using an external thermometer. The probe is inserted as if it is a column with a pre-defined length above the column nut to get consistent measurements between different instruments. Two setpoints (high and low) are measured. (Note: Due to the possible risk of radioactive contamination, ECDs are excluded from this service).

Extra Test 3. GC Oven Temperature Ramp: Accuracy, Linearity, and Precision [NOT CORE OQ TEST: additional extra fee test] Rationale: Most GC analyses use a temperature program instead of an isothermal oven temperature program to complete the separation of the compounds in the sample. For retention time reproducibility, it is important that the temperature program is always executed in the same way.

This test uses a calibrated digital thermometer to determine the accuracy, linearity, and precision of the GC oven temperature program. Linearity is defined as the coefficient of determination (r2) and uses data points that are part of the ramp. Ramp accuracy is defined as the slope of the linear curve fit through the same data points used for linearity calculations. Precision is calculated as the RSD over three temperatures in the slope over three different runs.

Procedure: In this test, a linear oven temperature profile is collected three times in a row using a digital thermometer and a data logger. For each run, the oven ramp accuracy and oven ramp linearity are calculated. After all three runs are completed, the oven ramp precision is calculated.

The ramp in use is a steep slope that challenges the GC to deliver high power in a reproducible way.

Extra Test 4-6. LTM Tests [NOT CORE OQ TEST: additional extra fee test]

Rationale: The RTD is a column packed in a heating foil. Although columns are generally considered to be consumables and not part of a hardware qualification, in this case the “oven” includes the column so tests are required to evaluate its functionality.

A direct temperature measurement (vs. indirect) is preferred but not feasible in this case given the LTM design: adding a temperature sensor to the metal foil introduces a cold spot and adversely affects temperature, and inserting a probe into the RTD requires taking the column apart.

One indirect temperature measurement is a direct measurement of the return voltage from the RTD, which can be converted to temperature using a known equation.

Another indirect temperature measurement would be chemical tests. If the system is not able to heat up in a reproducible way, you might see a shift in retention times. Because this kind of measurement is used by Agilent (and many other vendors) to evaluate system performance, it would be difficult for LTM to rework the complete chemical test suite: especially detector-specific tests like Signal to Noise and Signal Noise and Drift. The RTD can be any column and noise, in particular, is influenced by the column type.

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Operational Qualification (OQ) Hardware (continued)

OQ Test Design and Rationale for GC Systems (continued)

Based on the above, the following qualification is executed when an LTM is installed:

1. A complete GC qualification without Injection Precision (IP) is run with standard oven procedures. An LTM Basic Operation test is scheduled to show the LTM is functional.

2. An LTM Oven Temperature Accuracy and Stability test is executed. This test is similar to the standard GC Oven Temperature Accuracy and Stability.

3. An LTM Oven Temperature Ramp test is executed, similar to the standard GC Oven Temperature Ramp test, but it uses a much higher ramp.

4. The IP test is run using the LTM module. Inlet, detector, and RTD modules are tested separately in steps 1-3, but this test verifies that all components work together. LTM runs in general are very short due to the high oven ramp and very fast cool down rate.

Procedure for LTM Basic Operation: After completing the self test, four different temperatures (voltages) are measured: reference voltage (setpoint), return voltage (column temperature), and both transfer lines. This assures that all zones are functional, correctly installed, and connected.

Procedure for LTM Oven Temperature Accuracy and Stability: This test uses a calibrated voltmeter to determine temperature accuracy and stability of the LTM oven. (Voltages are measured and then converted to temperatures using a known relation. The converted temperatures are used in all calculations and limit comparisons.)

Procedure for LTM Oven Temperature Ramp: This test uses a calibrated voltmeter to determine the accuracy, linearity, and precision of the LTM oven temperature program. (Temperatures cannot be measured directly for LTM ovens, so voltages are measured and then converted to temperatures using a known relation. The converted temperatures are used in all calculations and limit comparisons.) Linearity is defined as the coefficient of determination (r2) and uses data points that are part of the ramp. Ramp accuracy is defined as the slope of the linear curve fit through the same data points used for linearity calculations. Precision is calculated as the RSD over three temperatures in the slope over three different runs.

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Operational Qualification (OQ) Hardware (continued)

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.)

* Pressure-balanced HSS

** Temperatures over 150 °C only applicable to 7697 HSS

Agilent Operator (verifies variances are entered into ACE):Name:Signature, Date:

Customer:Name: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@e651ac8b0740be1e650e9adf with your OQ test specification requirements. Fees may apply.

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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

Mainframe Strategies

Repair/Replace Strategy OQ/PV Testing

Main board System Insp. & Basic Safety & Op.

GC Oven Temp. Acc. & Stability

Inlet Pressure Accuracy

Detector Flow Accuracy

GC Oven Temp. Ramp

Keyboard System Insp. & Basic Safety & Op.

EPC board Inlet Pressure Accuracy

Detector Flow Accuracy

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.

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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: July 2012

Services R&D Manager: Dr. Jonathan Gray. Santa Clara, California USA.

Services Quality Manager: Doug McDougall. Wilmington, Delaware USA.

Enterprise Edition is endorsed by Dr. Ludwig Huber on behalf of e651ac8b0740be1e650e9adf.

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 GC Enterprise Edition Protocols.

A.01.79 July 2012Added support for Agilent 7650A Sampler. Updated ASTM noise algorithm for the Signal-to-Noise and

Noise & Drift calculations. Enhanced graphical representation. Enhanced integration and compatibility

with HSS for the FID Response Linearity test.

A.01.78 April 2012Added support for PTV inlet in Inlet Temperature Accuracy test. No regulatory impact for previously

approved EQP’s.

A.01.77, February 2012 Added support for: (1) Agilent Ion Trap 220 and 240. (2) Varian/Bruker GC 430 and 450. No regulatory

impact for previously-approved Standard_EQP documents.

A.01.76, August 2011No changes to GC. Protocol revision made independent from ACE revisions. No regulatory impact.

A.01.75, March 2011No changes to GC. Added HSS third heated zone Temp Accuracy for model 7696.

A.01.74, September 2010No changes to GC.

A.01.73, June 2010(1): Added selection boxes for Optional Tests.(No regulatory impact).

A.01.72, January 2010Added support for Perkin Elmer HS40XL and TurboMatrix 40 headspace samplers.

A.01.71, October 2009Added E-signature fields (NO REGULATORY IMPACT)

A.01.70, May 2009(1) Added Response Linearity (FID) test; (2) added GC Oven Temperature Ramp: Accuracy, Linearity, and

Precision test; (3) added 7693 ALS and Vial Heater Temperature Accuracy test; (4) added Agilent 7820

Series and Varian GC support; (5) updated noise and drift calculation. (NO REGULATORY IMPACT)

A.01.60, May 2008(1) Changed test spec (NO REGULATORY IMPACT): (a) Injection Precision for FID, CTC HSS limit now 3%

to 4% after evaluating world-wide data; (b) Inlet Pressure Decay limit now dual with existing pressure

decrease unchanged and new pressure increase at < 0.5 psi/5 minutes; (c) added Headspace Vent

and Pressurization Valve Integrity test; (d) updated noise and drift oven setpoint to 100 C, same limit;

(2) added G1883A HSS support; (3) added Japanese FPD standard (P/N 5188-5245) support; (4) added

forms: Certificate of System Qualification at end of EQR, Chromatography Report after each applicable

test, Errors and Corrections for operator and customer to record any corrections to EQR, Data Transfer

Audit Log for complete traceability.

A.01.53, August 2007Added kPa units for pressure tests.

A.01.50, March 2007

A.01.40, December 2006Initial GC - Operational Qualification

End of EQP Review Document

Page 18 of 19

e651ac8b0740be1e650e9adf/chem/enterprise

Information, descriptions and specifications in this

publication are subject to change without notice.

? Agilent Technologies, Inc. 2012

Published in USA, July 25, 2012

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