Regulatory Requirements for Analytical Instrument Qualification (AIQ) and Recent Trends

Analytical Instrument Qualification (AIQ) is the analytical foundation for data quality in regulated laboratories. First released in 2008 and updated in 2017, USP General chapter <1058> on AIQ remains a key regulatory reference for laboratory compliance.

This presentation will explain how to comply with USP <1058> requirements and will look at the relationship between USP <1058> and GAMP, along with regulatory trend information and compliance findings.

Presenter: Paul Smith (Strategic Compliance Specialist, Agilent Technologies)

Paul has a passion for laboratory compliance. He started his career as an Infrared Spectroscopist, recording and interpreting infrared and Raman spectra and chemometric modeling of FT-IR, Raman and NIR data. He did his first software validation work in 1992, before moving into broader analytical chemistry and laboratory management roles. Overall, he spent 17 years in the pharmaceutical industry and has worked in laboratory consultancy roles for the last 20 years.

He has worked in Pharmaceutical R&D, New Product Introduction and Quality Assurance. In his current Agilent role, he monitors laboratory compliance change and non-compliance trends, sharing this information with customers and colleagues. He is an active member of GAMP, contributing to Good Practice Guides and is a steering committee member of the UK GAMP Community of Practice, which focusses on sharing knowledge and learning with industry.