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Project Scope

  • Define role of QTLs in QbD, in particular the relationship to CTQs (Critical to Quality Factors), Estimands and continuous quality improvement (CQI)
  • Discuss the use of QTLs in Early Development/small studies, bio equivalence and complex designs
  • Discuss examples of how to define QTLs, different methodologies and different parameters in use across the industry
  • Discuss difficulties and challenges of implementation of QTLs
  • Examine role of QTLs as part of the of the lessons learned (RCA) feedback loop
Project LeadsEmail
Lauren White (PHUSE Project Co-ordinator)

Objectives & DeliverablesTimelines
White PaperQ22022


This is a new project and is actively seeking participation. If you are interested in joining this team, please email

Presentation sent to the FDA regarding the Project Scope, resulting in FDA members attending meetings when possible.​

- Q&A log.​

- Questionnaire in draft. 

Project MembersOrganisation
Adam Czernik Janssen Research and Development
Alicja MarkGenmab
Andrew McGowanRHO World
Andrzej KinasiewiczAstraZeneca
Anne LawrenceAbbVie
Ansalan StewartFDA
Arati TodkarTCS
Chonna CampbellUnither Pharmaceuticals
Crupa KurienPfizer
Georgina WoodCyntegrity 
Heather TurnerPrism
Heidi HoffmanGenentech
Jean MulindeFDA
Julie AppelNovo Nordisk
Karen BleichFDA
Kate TomlinsonPRISM
Linda Del PaggioGenentech
Lukasz BojarskiAstraZeneca
Mary ArnouldAstellas
Project MembersOrganisation
Michael WalegaBMS
Mireille LovejoyRoche
Monika MoerschBoehringer-Ingelheim
Mukesh BabuIndustry
Nick Wells Syneos Health 
Paul BrownDanish Medicines Agency
Priti GuptaPfizer
Shalaka GadhaveTCS
Sheetal ChandaranaRoche
Steve Young CluePoints
Steven GilbertPfizer

Problem Statement

QTLs -  the role they play in defining quality within the QbD framework, their relationship to Critical to Quality factors, associated methodologies and the interpretation of them have not been fully defined in clinical development, in particular where early development/small studies, bio equivalence studies and complex designs are concerned.

Problem Impact

This will impact the whole clinical development process and allow the move away from perfection to a defined and achievable quality, from which continuous quality improvement can begin.

Terminology Example:

  • Target Product Profile (TPP)
    • Patient wants extended dosing from current BD product on market
  • Critical Quality Attribute (CQA)
    • Once a day dosing
  • Critical to Quality Factor (CTQ)
    • In early stage trials drug levels shown at 24 hours
    • In Phase 2-3 demonstrate efficacy
  • Quality Tolerance Limit
    • Pre-define what will be acceptable limits for acceptance
      • These QTL's will change at different stages

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