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  • Qualification of Analytical Scale HPLC SystemsAgilent 1200, 1220, 1260, & 1290 Infinity Series (HPLC & RRLC); Agilent 1120/1100/1090 Series HPLC and Select Non-Agilent HPLC Models, with operating pressure range below 400 bar

    REVIEW DOCUMENT NAME:Agilent_Recommended_EQP: HPLC

    EQUIPMENT QUALIFICATION PLAN (EQP)

    Agilent Enterprise Edition Compliance Services

    Page 1 of 17

  • Page 2 of 17

    Agilent_Recommended_EQP

    Agilent Technologies, Inc. 2014

    Document Released: April 2014 Enterprise Edition Compliance Services

    No reproduction, translation, or use without permission

    How to Use This DocumentThis 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 Agilents 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, both for Agilent and non-Agilent systems (see attachment).

    All tests in this document exist in all Agilent delivery tools. The tests descriptions for Capillary Scale and Preparative Scale HPLC are also detailed in dedicated attachments to this document. 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) Non-Agilent test specifications; (ii) Question and Answer document; (iii) 21 CFR Part11 Conformance Checklist for the Agilent Compliance Engine (ACE) - the Enterprise Edition delivery tool; (iv) 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 EQPThe 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 FIXED Agilent 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.

  • Page 3 of 17

    Agilent_Recommended_EQP

    Agilent Technologies, Inc. 2014

    Document Released: April 2014 Enterprise Edition Compliance Services

    No reproduction, translation, or use without permission

    ContentsTo 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 HPLC Systems (*) ................................................................ 7

    OQ Test Design and Rationale for Analytical Scale HPLC Systems ......................................................................... 9

    EQP Record of Variances to Setpoints from Standard OQ Specifications .............................................................. 13

    Re-Qualification after Repair (RQ) Hardware ........................................................................................................... 14

    Legal and Endorsement ............................................................................................................................................... 15

    Revision History ............................................................................................................................................................ 15

    Why Has Agilent Introduced the New Compliance Service, Called Enterprise Edition?IntroductionAgilent (then we were HP Analytical) introduced OQPV for our own LC and GC instruments in the early 1990s and since then we have delivered well over 100,000 OQPV reports to customers around the world. Despite the undoubted success and acceptance of our old OQPV (now called Classic Edition to distinguish from the new Enterprise Edition service) times have changed. Expectations and requirements of an OQ have slightly shifted. The number and type of instruments and software used by our customers has increased. And of course we are truly in the new world of computers and electronic media.

    So Agilent set out with a team of international experts 3 years ago to create an upgraded compliance service that would meet the new demands but crucially maintain the fundamental requirements:

    Always pass FDA and national agency audits without over-testing or under-testing;

    Challenge the LC or GC system with a scientifi cally sound methodology that provides valuable performance data.

    Meet the quality needs of customers and the spirit & intention of the GLP & GMP laws.

    Offer this service at a cost-effective price that makes it more than just worthwhile we hope it is the simplest & best qualifi cation choice that a customer can make.

    What Are The High Level Changes In Enterprise Edition And What Were The Drivers For These Changes?The fi rst big driver was the software environment. A greatly increased number of chromatography data system (CDS) products are available to control LC and GC systems. Agilent has ChemStation, Cerity, EZChrom, OpenLab and some specialist LCMS/GCMS software. Our customers also use Empower, Chromeleon, Atlas, Turbochrom and many others. Classic OQPV was built into ChemStation software. The Classic OQPV is a miracle of validated and almost fully automated OQ testing. But these benefi ts are therefore limited to Agilent instruments running on ChemStation. To provide all our customers, and customers of non-Agilent instruments, a single OQ solution as good as (or better than) OQPV it was clear we had to develop an automation tool independent of ChemStation and any other CDS.

    The Agilent Compliance Engine (ACE) is our new software tool that manages the workfl ow and protocols, calculates results and produces the reports. Naturally it is fully validated and tested. Our service engineers carry ACE laptops in the same way as they carry ChemStation laptops. Alternatively our contract customers can have the ACE software on their own laptops or installed with Agilent OpenLab networked CDS.

    Table of contents: [click on title for fast navigation]

    What Are The High Level Changes In Enterprise Edition And What Were The Drivers For These Changes?

    Any Other Practical Or Process Changes In Enterprise Edition?

    Lets Dive Into The Details How Do The Protocols And Tests In Enterprise Edition Compare To Classic Edition?

    List Of Enterprise Edition OQ Tests Versus Classic OQPV Tests For LC:

    What About The Reports, How Are These Different To OQPV Reports?

    What Would I Have To Do If I Wanted To Move My Annual OQ Service From Classic To Enterprise Edition?

    What Are The Main Risks To Migrating To Enterprise Edition And How To Avoid Them?

    Finally, Can You Summarize The High Level Comparison Of Enterprise Edition Versus Classic Edition Compliance Services?

    EE 1.76 Comparison Document

    Preparative Scale Tests Descriptions

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

    Capillary Scale Tests Descriptions

    Tests definitions for Non-Agilent Systems

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

  • Page 4 of 17

    Agilent_Recommended_EQP

    Agilent Technologies, Inc. 2014

    Document Released: April

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