The proposed revision to USP  <1058> introduces a significant change in the approach to analytical instrument and system qualification (AISQ).  Instead of considering qualification as a series of isolated events, the updated chapter adopts a risk-based life-cycle approach that encompasses the entire life cycle of an analytical instrument—from specification and selection through installation and performance verification to eventual retirement.  This perspective emphasizes that qualification is a continuous assurance process rather than a one-time checklist.

A noteworthy aspect of the revision is the restructuring of the content.  Rather than simply amending the 2017 chapter, the Chemical Analysis Expert Committee has overhauled the framework based on insights from three key stimulus articles.  These articles highlight the importance of supporting analytical procedure validation throughout the life cycle, incorporating measurement uncertainty into the qualification process, and detailing the qualification life cycle itself.  This update aligns AISQ with modern quality management practices and scientific thinking, enhancing the robustness and relevance of the guidance.

Several key factors drove this update:

    1. Modernization of Qualification Practices:  The original chapter (at least the 2017 version) was based on a traditional view of qualification.  New scientific insights have shown that instruments and systems evolve during their operational life, and a practical approach must continuously assess their “fitness for the intended use.”  The revision introduces a dynamic framework, integrating initial qualification activities with ongoing performance verification.
    2. Incorporation of Risk-Based Principles:  The update’s significant impetus is the shift toward risk-based quality management.  The new guidelines prompt laboratories to evaluate potential risks, such as measurement uncertainties or performance drift, and adjust the scope and intensity of qualification activities accordingly.  This tailored approach allows labs to focus on the resources with the most significant impact on data quality and integrity.
    3. Integration of the Emerging Industry Best Practices:  The update directly results from the insights from three key articles published in the Pharmacopeial Forum.  These stimuli have broadened the understanding of how instrument qualification can support continuous analytical procedure validation and incorporate measurement uncertainty concepts.  By aligning with these developments, the USP ensures its guidance remains current with industry standards and the latest scientific thinking.
    4. Holistic Systems Consideration:  Recognizing that analytical results depend not just on standalone instruments but also on integrated systems (including software and connected processes), the chapter is being renamed from “Analytical Instrument Qualification” to “Analytical Instrument and System Qualification.”  This change reflects a broader perspective that acknowledges the importance of system-level interactions and interdependencies in ensuring robust quality management.
    5. Enhanced Regulatory Compliance and Stakeholder Engagement:  With changing regulatory expectations and a demand for greater transparency in quality processes, the proposed update offers a more comprehensive framework for laboratories.  The invitation for public comment until May 31, 2025, also underscores the USP’s commitment to stakeholder engagement and continuous improvement based on real-world experiences.

 

The draft proposal is organized into eight comprehensive sections, which include:

    1. Introduction
    2. Interrelationships with Other USP General Chapters
    3. Life-Cycle Processes for Qualification and Validation
    4. Risk Assessment to Establish the Extent of Qualification and Validation Activities
    5. Life-Cycle Models for Qualification (including the 4Qs Model) and Validation in AISQ:
      • This section retains the familiar four-stage model: Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), while integrating these stages into a broader life-cycle context.
    1. Calibration for Establishing “Fitness for Intended Use”
    2. Change Control over the Life Cycle
    3. Roles and Responsibilities over the Life Cycle

 

For laboratories and other regulated environments, this revision has several practical implications:

  • Enhanced Alignment with Risk-Based Strategies: This approach supports a more dynamic qualification strategy that anticipates change, prompting organizations to integrate qualification with ongoing performance monitoring and change control, thereby supporting compliance and data integrity in an evolving regulatory landscape.
  • Holistic Quality Management: By connecting AISQ with the life cycle of analytical procedures and process validations, laboratories can better manage the relationship between equipment performance and product quality.  This integrated perspective can improve predictive maintenance, more efficient calibration practices, and a sharper focus on measurement uncertainties.
  • The proposed update modernizes the technical guidelines and reflects broader trends in quality assurance by embracing continuous verification and a systems-thinking approach. It encourages laboratories to adopt more proactive and integrated strategies rather than relying on periodic, discrete checks.

 

If you are involved in analytical operations or quality management, consider how these changes could be implemented in your current systems.  For example, how might integrating ongoing performance verification impact your calibration schedules or change management processes?  What strategies could you adopt to balance the traditional 4Qs model with a broader, life-cycle-focused approach in your daily operations?

There is also the opportunity to explore how this update aligns with similar life-cycle approaches in other regulations or guidance documents, such as ICH Q12, which emphasize managing post-approval changes through a well-defined quality system.

By adopting these updated guidelines, laboratories can better align with modern risk-based approaches and system-oriented practices that are crucial for maintaining high levels of quality and compliance.  This change modernizes their operational procedures and ensures that instruments remain reliable and that data integrity is preserved throughout their life cycle.

If you have any questions regarding this topic, Lachman can help!  Contact us at LCS@lachmanconsultants.com for a consultation.