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1 Analytical l Instrument t Qualification According to USP <1058> Scope, Approach, Requirements Dr. Ludwig Huber Chief Advisor, Global FDA Compliance ludwig_huber@labcompliance.com
2 Overview FDA and International requirements and enforcement The history, objective, scope The USP Approach for Instrument Qualification Four Phases: DQ, IQ, OQ, PQ Instrument categories: Recommended procedures and qualification tasks DQ: Design Qualification IQ: Installation Qualification OQ: Operational Qualification PQ: Performance Qualification Copyright Ludwig Huber - LabCompliance Slide 2
3 Reference Material SOPs Allocating Analytical Instruments to USP <1058> categories Procedures and deliverables for USP <1058> categories FDA Presentation on Equipment Qualification, includes acceptance criteria Examples for FDA Warning Letters related to Analytical Instrument Qualification (available until September 2010) Copyright Ludwig Huber - LabCompliance Slide 3
4 Regulations and Quality Standards All GLP, GCP and GMP regulations require analytical equipment to calibrated or qualified Example: FDA cgmp 21 CFR b(4) requires The calibration of instruments, apparatus, gauges, and recording devices at suitable intervals in accordance with an established written program containing i specific directions, schedules, limits it for accuracy and precision, Instruments not meeting established specifications shall not be used. GLP: Good Laboratory Practices GCP: Good Clinical Practices GMP: Good Manufacturing Practices Copyright Ludwig Huber - LabCompliance Slide 4
5 FDA Warning Letters Your firm failed to conduct injector and detector performance testing for the HPLC system For example, no HPLC injector and detector testing for linearity, accuracy, and precision were conducted, d such as various injection volumes and standard concentration testing evaluation of detector for noise/drift; carryover testing to evaluate response at low levels to determine the detection of possible interferences that may affect peaks of interest. Ref: (W-221) Copyright Ludwig Huber - LabCompliance Slide 5
6 USP General Chapter <1058>: Analytical Instrument Developed by an expert team with participation of US FDA, industry and USP Released in 2008 General chapter above 1000 means Other procedures can be used for qualification as long as results are equivalent to USP Mandatory if a USP monograph requires equipment to be qualified or calibrated The approach is applicable to all analytical instruments in regulated laboratories Approach: 4Q model Copyright Ludwig Huber - LabCompliance Slide 6
7 AIQ and Other Quality Checks 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 t analytical l 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 Copyright Ludwig Huber - LabCompliance Slide 7
8 Qualification/Validation Phases 4Q Model + Design specifications for development Design Qualification Installation Qualification Operational Qualification Performance Qualification User requirement specifications Functional specifications Operational specifications Vendor qualification Check arrival as purchased Check proper installation of hardware and software Test of operational functions Performance testing Test of security functions Test for specified application Preventive maintenance On-going performance tests Copyright Ludwig Huber - LabCompliance Slide 8
9 Design Qualification (DQ) Documented collection of activities that define the functional and operational specifications of the instrument, t based on intended d purpose Shared responsibility between vendor and user Activities iti and Documentation ti Vendors Design, develop and manufacture instruments in quality control environment 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 Copyright Ludwig Huber - LabCompliance Slide 9
10 Installation Qualification (IQ) Documented collection of activities to ensure that equipment Is delivered as designed and specified Is properly installed in the selected ected environment e That the environment is suitable for the instrument Activities and Documentation Verify that facilities, utilities, and environment meet vendor requirements Assemble and install equipment Perform initial diagnostics and testing For complex pe equp equipment: e run reference e e sample pe Document installation, including drawings Copyright Ludwig Huber - LabCompliance Slide 10
11 Operational Qualification (OQ) Documented collection of activities necessary to demonstrate that an instrument will function according to its operational specifications in the selected environment Activities and Documentation 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. Copyright Ludwig Huber - LabCompliance Slide 11
12 Performance Qualification (PQ) Documented collection of activities necessary to demonstrate that an instrument consistently performs according to specifications as defined by the user, and is appropriate for the intended use. Activities and Documentation 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 Copyright Ludwig Huber - LabCompliance Slide 12
13 Instrument Categories Three instrument categories: A, B, C Level of qualification depends of the type of instrument and on application User defines category and level of qualification Magnetic Stirrers Vortex Mixers Balances ph meters HPLC Systems Mass spectrometers Visual inspection May not require e formal qualification Verification with specifications Full qualification Copyright Ludwig Huber - LabCompliance Slide 13
14 Recommended Procedures for Categories (1) A (2) B (2) C (2) Operation Operation Operation Qualification Qualification Change Control Configuration Management Back-up, Restore and Archival Security System Administration Preventive maintenance Preventive maintenance & repair & repair Problem Reporting Problem Reporting Problem Reporting Periodic Review Retirement (1): Recommended by Labcompliance (2): Approaches, activities and procedures should be defined in an equipment qualification master plan Copyright Ludwig Huber - LabCompliance Slide 14
15 Qualification Deliverables for Categories Recommended by Labcompliance A (1) B (2) C Vendor specifications Qualification Plan (2) Qualification Plan User Requirements User Requirements Specification (2) Specification Risk assessment Vendor s Quality System Vendor s Quality System Supplier Assessment Checklists used during DQ and IQ (2) DQ and IQ initial inspection OQ and PQ tests OQ and PQ tests Maintenance, repair and Maintenance, repair and change logs change logs Qualification Report Qualification Report (1) Category A may not require formal qualification of each individual instrument (2) Use template format for instrument category B Copyright Ludwig Huber - LabCompliance Slide 15
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