1. AIQ Analytical Instrument Qualification

2. AIQ – Analytical Instrument Qualification Varian, Inc.’s Analytical Instrument Qualification documentation has been produced to help our customers meet their regulatory requirements in respect to AIQ. Our goal is simple – we want to remove this task from their work force and maximize their uptime through AIQ preventative measures. Benefits include: Saves customer’s time and money so they can focus their labour force on other value-added tasks Provides an audit trail of compliance in order to satisfy the requirements of regulatory agencies and other organizations Maximizes productivity through qualification testing that shows the instrument is performing according to Varian’s specifications Minimizes risk associated with 3rd party service suppliers not knowing aspects of our instrumentation – customer’s have Varian’s commitment to quality.

3. AIQ – Analytical Instrument Qualification Analytical Instrument Qualification (AIQ) is the documented evidence that an instrument is fit for its intended purpose. Use of a qualified instrument in analyses contributes to confidence in the validity of generated data. AIQ consists of 4 major stages Design Qualification Installation Qualification Operation Qualification Performance Qualification

4. AIQ – Analytical Instrument Qualification Design Qualification Performed by the customer Varian assist customers by: –AIQ overview –Instrument Brochures –Instrument Demonstrations –Customer Surveys –Customer Audits Defines the function and intended use of the instrument

5. AIQ – Analytical Instrument Qualification IQ System Description Utility/Facility/Environment – is the site set up correctly?? Instrument Delivery Network and Data Storage Assembly and Installation Initial diagnostics and testing of the instrument

6. AIQ – Analytical Instrument Qualification OQ Algorithm verification Fixed parameters Consumable Replacement Instrument function tests – automated where possible Customer Demonstration

7. AIQ – Analytical Instrument Qualification PQ is a documented collection of activities necessary to demonstrate that an instrument consistently performs according to specifications defined by the user and are usually based on the instruments typical on-site applications. Currently, only Dissolution products offer PQ services, while all other products do not include PQ support.

8. AIQ – Analytical Instrument Qualification Design Qualification Installation Qualification Operation Qualification Performance Qualification Prior to purchase of new instrument At installation of instrument After Installation or each major repair Periodically at specified intervals Timing of AIQ activities…. For more information see the AIQ Overview – 8510228900 Or Contact – compliance_vapl@varianinc.com

9. 900 LC -Series AIQ A full system test has been designed and implemented as part of the 900- LC Series Analytical Instrument Qualification package. This test verifies that the LC system, as a whole, functions correctly by systematically running the following accuracy and precision tests in a single automated test. Flow Rate Accuracy Test Wavelength Detector Accuracy Test Auto-sampler Injector Accuracy Test (also measures Detector Linearity) Auto-sampler Injector Precision Test Auto-sampler Injector Carryover Test Proportioning Accuracy Test Detector Noise Test Detector Drift Test Auto-sampler Vial Identification Accuracy Test Proportioning Linearity Compositional Ripple

10. AIQ – Analytical Instrument Qualification Varian, Inc. are also standardising AIQ products: All documentation for new products will have the same format The content of the IQOQ will be similar across product lines Training for staff will be consistent IQOQ Labels for instruments will be consistent For more information contact: tara.carruthers@varianinc.com