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Quality Tolerance Limits – Threshold Setting Methodologies

    Quality Tolerance Limits – Threshold Setting Methodologies

    Oct 01, 2025

    Project Scope 

    The Project has successfully completed the first step of clarifying the definitions and labels linked to QTL monitoring. Recommendations on how to derive thresholds for QTL monitoring have been developed.  

    The next stage shall be to: 

    • Share this acquired knowledge and common understanding within the industry. 
    • Continue the discussion on further refining the (statistical) methodology regarding threshold derivation for QTL monitoring. 

    Closely follow ICH (R3) developments regarding risk-based monitoring and discuss/evaluate whether this has impacts on the guidance provided so far (QTL vs. acceptable range). 

    Project LeadsEmail
    Nathalie van Borrendam, Johnson & Johnsonnvanborr@its.jnj.com
    Annett Keller, Boehringer Ingelheim annett.keller@boehringer-ingelheim.com
    Alex Pearce, PHUSE Project Assistant 

    alexandra@phuse.global

    CURRENT STATUS (Updated Quarterly) 

    • Drafting white paper with the aim to finalise next quarter 
    Objectives & DeliverablesTimelines
    Challenges in QTL threshold setting – Experience sharing and high-level recommendations for the industryQ3 2022

    Guidance document on QTL threshold-setting methodologies

    		Q1 2023
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