USP AISQ Virtual Workshop: ECA AQCG Board Members Contributed as Speakers

From 23–25 June 2026, the USP hosted a virtual workshop on “Analytical Instrument and System Qualification (AISQ)”. The workshop focused on the calibration and qualification of analytical instruments and systems, and on ensuring that analytical results are fit for their intended purpose through a lifecycle approach aligned with USP <1058> and the Analytical Procedure Lifecycle (USP <1220>).

The objective of the workshop was "to provide an opportunity for USP-NF users to engage in an interactive discussion on the requirements to the implementation of an enhanced version of <1058> Analytical Instrument Qualification." 

USP General Chapter <1058> Analytical Instrument Qualification has been revised to move from the previous approach to a full lifecycle concept, and to better support USP <1220> Analytical Procedure Lifecycle.

Members of the ECA Analytical Quality Control Group (AQCG) Advisory Board contributed to the programme as speakers:

• Dr Christopher Burgess discussed the rationale for revising USP <1058> and provided a high-level summary of the public comments. He also presented "Instrument & system risk classification; What and how much needs to be done?" and "The journey to an enhanced <1058>; The next steps".
• Dr Bob McDowall presented an integrated approach to AISQ, outlining the rationale for introducing an integrated lifecycle in USP <1058>, including limitations of the 4Qs model due to differing interpretations in AIQ and CSV.
• Dr Joachim Ermer discussed the contribution of AIS qualification to the Analytical Procedure Lifecycle and ongoing procedure performance verification (OPPV).

For more information and workshop materials, please visit the USP event page.

The topics around USP <1058> and <1220> will also be addressed in several ECA events, and at PharmaLab 2026.