How to Comply with the New Revision of USP 1058 under a Lockdown

Analytical laboratories required to demonstrate the suitability of their equipment will generally follow USP Chapter <1058> on analytical instrument qualifications (AIQ). This chapter was first introduced in 2008 and remained unchanged for nine years, but it was updated on two separate occasions in 2017. Although the 2008 and 2017 versions of USP <1058> appear similar on first read, deeper analysis reveals the significance of the regulatory changes and their impact on laboratory compliance requirements. Changes in the 2017 revision of <1058> require descriptive risk assessment, documented user requirements and strong performance qualification (PQ) plans.

Many laboratories are unsure how to be compliant with the 2017 changes to USP <1058>. Those that have not addressed these changes will find it increasingly difficult to respond to the present lockdown environment. These rapidly changing work conditions make traditional laboratory services more difficult to provide in light of restrictive government and corporate policies. Services such as repairs, maintenance, calibrations and qualifications may be delayed, prompting laboratories to use alternative and/or expired equipment. Although these alternatives are not preferred, the principles behind this approach are supported by regulatory statements, provided these alternatives are backed through meaningful risk assessment. As well as explaining the significance of the 2017 <1058> changes, this webinar will suggest strategies for remaining compliant under a lockdown.

Speakers

Matt Abrahms, Americas Compliance Application Expert, Agilent

Matt Abrahms is a laboratory compliance specialist focused on instrument qualifications and computer system validation. He is a frequent speaker at Agilent’s compliance seminars and is a certified instructor for the USP’s performance verification test. He has performed over 100 instrument qualifications in a GMP environment and works closely with Agilent’s customers to comply with new regulatory updates. As a specialist he collaborates with Agilent’s solutions unit and service teams to ensure the quality of Agilent’s compliance delivery.

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Paul Smith, Global Compliance Specialist, Agilent

Paul Smith worked in a range of quality, laboratory and management roles during the 17 years he worked in the pharmaceutical industry. For the last 16 years, Smith has worked in consultancy roles, supporting harmonization of laboratory compliance and monitoring regulatory trends and changes. This includes changes to pharmacopeias, supporting the development of GAMP Good Practice Guides and monitoring FDA actions and observations. Smith is a regular contributor to journals in the area of analytical instrument qualification.

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