1. VALIDATIONS: TOWARDS RELAIBLE QUALITY OUTCOMES DR. SHIVPRAKASH MANAGING DIRECTOR SYNCHRON RESEARCH SERVICES PVT. LTD., INDIA

2. THE COMPONENTS OF DATA QUALITY Analytical Instrument Qualification Analytical Methods Validation System Suitability Tests Quality Control Checks

3. COMPONENTS OF DATA QUALITY Analytical Instrument Qualification: is documented evidence that an instrument performs suitably for its intended purpose that is properly maintained and calibrated. Analytical Methods Validation: accuracy, precision, sensitivity, specificity, repeatability, linearity, analyte stability. System Suitability Tests: to verify that the system works according to the performance expectations and criteria set forth in the method. Quality Control Checks: provide an in-process assurance of the test’s performance suitability.

4. ANALYTICAL INSTRUMENT QUALIFICATION Phases of Qualification: Design Qualification (DQ) Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ)

5. DESIGN QUALIFICATION DQ activity is most suitably performed by the instrument manufacturer. For COTS systems, the used does not need to repeat all aspects of DQ. But ensure the vendors adequately support installation, service, and training.

6. INSTALLATION QUALIFICATION System Description: of instrument, manufacturer, model, serial number, software version etc.,. Instrument Delivery: Ensure that the instrument, software, manuals, supplies, and any other accessories arrive with the instrument as the purchase order specifies and that they are undamaged. Utilities/Facility/Environment: Verify that the installation site satisfactorily meets vendor-specified environmental requirements. Network and Data Storage: If requires connect the instrument to the network and check its functionality. Assembly and Installation: Assemble and install the instrument and perform any diagnostics and testing. Installation Verification: test the installation and obtain acceptable results before next phase of validation.

7. OPERATIONAL QUALIFICATION Fixed Parameters: non-changing parameters like height, weight, length etc. therefore never need redetermining. Secure Data Storage, Backup, and Archive: should be tested at the user site according to the written procedures. Instrument Function Tests: Vendor-supplied information is useful in identifying specifications for these parameters. Some possible tests during OQ: pump flow rate, gradient linearity, detector wavelength accuracy, detector linearity, column oven temperature, peak area precision, peak retention time precision.

8. PERFORMANCE QUALIFICATION Performance Checks: PQ specifications can be slightly less rigorous than the OQ specifications. The tests can be modular or holistic. Preventive Maintenance and Repairs: Relevant PQ test(s) should be repeated after the needed maintenance or repair to ensure that the instrument remains qualified.

9. ROLES AND RESPONSIBILITIES USERS: Users are ultimately responsible for the instrument operations and data quality. Users group includes analysts, their supervisors, and the organizational management. QUALITY ASSURANCE: The QA role in AIQ remains as it is in any regulated study. MANUFACTURER: Responsible for DQ and for validating relevant processes for manufacturing and assembly of the hardware and validation of software associated with the instrument.

10. SOFTWARE VALIDATION Software used for analytical work can be classified into following categories: Firmware Instrument control, data acquisition, and processing software Stand-alone software

11. SOFTWARE VALIDATION CONT… FIRMWARE: The computerized analytical instruments contain integrated chips with low-level software (firmware). Such instruments will not function without properly operating firmware, and user usually cannot alter firware’s design or function. INSTRUMENT CONTROL, DATA ACQUISITION AND PROCESSING SOFTWARE: Operations are controlled via the software, leaving fewer operating controls on the instrument. The manufacturer should perform the DQ, validate this software, and provide users with a summary of validation. STAND-ALONE SOFTWARE: An authoritative guide for validating stand-alone software, such as LIMS, is available through USFDA General Principles of Software Validation.

12. CHANGE CONTROL Changes to the instrument and software become inevitable as manufacturers add new features and correct known defects. Users should adopt only the changes they deem useful and necessary. Change control follows the DQ/IQ/OQ/PQ classification process. Change control SOP is necessary.

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