1. 1 Importance of Instrument Validation for Accredited Food Export Testing Labs

2. Copyright Slide 2 Overview Why laboratory accreditation for food testing Overall requirements for accredited food testing laboratories Quality checks in the laboratory related to analytical instrument qualification Qualification vs. Verification Essential steps and example templates for Instrument Qualification: DQ, IQ, OQ, PQ Requalification: when, what Reference material: www.labcompliance.com/agilent Available until March 10, 2014

3. Copyright Slide 3 Value of ISO 17025 Country A Product shipped from country A to B Country B Routine testing only tested in one accredited laboratory of country A International comparability of test results through traceability to the same standard Confidence in test results through estimated and documented measurement uncertainty

4. Copyright Overall Requirements of ISO 17025 Sampling Sample handling TestingTest reports Record maintenance Sampling plan & sampling documentation Sample identification & protection of sample integrity Monitoring the quality of test results Test conditions & test results, with estimated uncertainty Ensure record integrity & security Controls across all workflow steps Validation of analytical methods & procedures Equipment calibration validation & maintenance Qualification of material Traceability Handling Out-of-specification results Qualification of personnel Controlled environmental conditions Written procedures Quality system controls across the laboratory Documentation control, corrective & preventive actions, complaint handling, supplier & subcontractor management, internal audits, change management, management reviews, continuous improvement, product reviews Slide 4

5. Copyright Slide 5 Quality Checks in Laboratories Quality control checks –Verifies accuracy of sample analysis System suitability tests –Verifies that the system performs according to analysts expectations Analytical methods validation –Proof that analytical procedure does what it purports to do Analytical instrument qualification –Forms the base for generating quality data –Proof suitability of the instrument for intended use

6. Copyright Slide 6 Equipment Calibration, Qualification, Maintenance – ISO 17025 Laboratory equipment should be furnished with correct performance of tests Equipment and software shall comply with specifications relevant to the tests Before placed into service, equipment should be calibrated or checked to verify specifications Shall be operated by authorized personnel Should be uniquely identified Procedures for safe handling and preventive maintenance Defective equipment shall be taken out of service Shall be labeled to indicate status of calibration

7. Copyright Verification vs. Qualification Verification (ISO/IEC Guide 2) Confirmation by examination and provision of evidence, that specific requirements have been met Assumption: Specific requirements are defined Verification Step: Examine and confirm that specific requirements are met Operational Qualification (Pharma, PDA) Documented verification, that a system operates according to written and pre-approved specifications throughout all specified operating ranges Assumption Requirements are defined for specified operating ranges Qualification step Examine and confirm that pre- approved requirements are met Slide 7

8. Copyright Slide 8 United Nations – Complying with ISO 17025 Guidebook Equipment All new equipment must be checked for correct functioning before being placed in routine service. This should include checks against the manufacturer's specifications and checks to confirm that the equipment gives satisfactory results when used to make the measurements for which it is intended. DQ – IQ- OQ -PQ

9. Copyright Slide 9 Design Qualification Installation Qualification Operational Qualification Performance Qualification Qualification/Validation Phases 4Q Model l User requirement specifications l Functional specifications l Operational specifications l Vendor qualification l Check arrival as purchased l Check proper installation of hardware and software l Test of operational functions l Performance testing l Test of security functions l Test for specified application l Preventive maintenance l On-going performance tests Based on official standard (USP Well known to industry and agencies Most safe approach for food testing labs

10. Copyright Slide 10 Qualification Project Plan Template Scope of the Plan Product Description Validation Strategy Responsibilities Supplier Assessment Risk assessment Testing Strategies DQ IQ OQ PQ Traceability matrix Procedures Approval Documentation control

11. Copyright Slide 11 Design Qualification (DQ) Activities and Documentation Vendors –Design, develop and manufacture instruments in quality control environment, e.g., ISO 9001:2008 –Develop functional and operational product specifications Users –Develop user requirement specifications –Verify that the vendor’s instrument meets user’s requirements: product specifications, delivery and support –Verify that the vendor operates in a quality system environment

12. Copyright Slide 12 Design Qualification - Template Function/ Performance User Requirement Supplier Specification Comment yes/no Function 1 Function 2 Physical Requirements Construction Requirement Vendor Requirement

13. Copyright Slide 13 Installation Qualification (IQ) Vendor Provides the user with environmental specifications and a site prep document Provides Offers services for IQ with inspection ready documentation User Verify that facilities, utilities, and environment meet vendor requirements Assemble and install equipment Perform initial diagnostics and testing For complex equipment: run reference sample Document installation, including drawings

14. Copyright Slide 14 Equipment Documentation for IQ Identification ManufacturerBest HPLC ModelD4424A Firmware revision1.00 Serial NumberE4431A Internal ID (Asset number)D33243 Current locationGlab4 Size (w x b x h) (cm)30x22x7 Condition when installedNew Supplier contact phone for services 1+541-64532 Example: HPLC detector

15. Copyright Slide 15 Operational Qualification (OQ) Vendor Provides services for OQ with traceable tools Delivers inspection ready OQ documentation Makes recommendations for frequency of requalification User Test functions to verify that the instrument operates in the user’s environment as intended by the manufacturer and required by the user. Test secure data handling, storage, back-up and archiving Tests can be holistic or modular. Tests can be done by users or qualified designees.

16. Copyright Slide 16 OQ Test - Example Date Weight 1Weight 2 Test engineer NameSignature Weight 3o.k. yes 9999.8 999.9 100.0Hughes 2/3/06 InstrumentBestBalance Serial number55236A Maximal weight11 g Control weight 110,000 mgLimit +-10 mg Control weight 21,000 mgLimit: +-1 mg Control weight 3100 mgLimit: +- 0.1 mg

17. Copyright Slide 17 Performance Qualification (PQ) Vendor Provides recommendation for PQ tests, e.g., for system suitability testing Provides software for PQ testing, e.g., for system suitability and quality control charts User Preventive maintenance to ensure trouble free operation for the intended application Performance checks, based on the instrument’s typical on-site applications –Test frequency depends on the ruggedness of the instruments and the criticality of the tests – System suitability and QC tests can imply suitable performance

18. Copyright Slide 18 Documentation of PQ Testing TestTest Case Expected resultActual Result Pass/ Fail Baseline Noise T10<1x10-4 AUPass Resolution between compound A and B T11>2.0 Tailing factorT12<1.3 Precision of amount compound A, 6 replicate injections T13<1% Precision of amount compound B, 6 replicate injections T14<1% Example: HPLC System

19. Copyright Slide 19 Summary Report Template Scope of the report Product Description Qualifiaction Strategy Responsibilities Supplier Assessment Risk assessment Testing Strategies DQ IQ OQ PQ Traceability matrix Procedures Deviations Approval Documentation control

20. Copyright Slide 20 Define System Use Installation Qualification Operational Qualification Performance Qualification Validation Phases – 4Q Model APPROACH FOR EXISTING EQUIPMENT l Document equipment use l Document applications l Document used functions l Enter all modules and systems in a database l Hardware, Firmware, Software l Document past tests l Test of functional specifications l Test of performance functions l System test (system suitability testing) l Preventive maintenance + Change Control

21. Ludwig Huber Labcompliance Sponsored by Slide 21 Thank You I would like to thank All attendees for your attention Agilent Technologies for invitation and organization For links to Instrument Validation references, please check www.labcompliance.com/agilent (Available until March 10, 2014) Dr. Ludwig Huber Ludwig_huber@labcompliance.com