Changes in the 2017 revision of <1058> require descriptive risk assessment, documented user requirements, and strong performance qualification (PQ) plans.
TORONTO (PRWEB) June 26, 2020
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.
For more information or to register for this event, visit How to Comply with the New Revision of USP 1058 under a Lockdown.
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