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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
      , multiple selections available,
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