A change in the Quality paradigm to reduce the burden of retrospective, time-consuming traditional QA activities, and ultimately accelerate approval and patient access to innovative products.

Goal

  • To ensure quality maintains pace with technological advances, using an outcomes-based approach enabled by Quality Briefs* (QBs), supporting innovation to support risk-based assessment and decision making to get new products to patients without delays. To create QBs as a living entity, serving from molecule, filing, through to post-approval and inspections across the pipeline.
  • To influence & engage Health Authorities through building trust and confidence via proactive provision of QBs with clear Quality Position conclusions based on risk-assessed Critical to Quality (CtQ) Factors ; ultimately reducing compliance delays on route to approval.
  • To create a future of quality professionals acting as enablers of innovation rather than traditional gatekeepers.

Expected Outcomes

  • Establish agreed Quality Brief methodology and template available for IMPALA members to pilot
  • Establish implementation toolkit & guidance for QBs for IMPALA members to pilot implementation
  • Pilot use of QBs with selected Health Authorities to engage, influence & ensure fit for purpose: building trust & confidence.
  • White paper on QB methodology, including risk assessment of Critical to Quality Factors, associated Quality Strategy, evidence-based Quality Position Conclusions and outcomes-focus published for open-source availability to industry and Health Authorities
  • Long term: Influence Policy so QBs are understood by Health Authorities in both a filing & inspection context

Lead(s)

  • Kiernan Trivett

Resources

Coming soon…

On this page:

Status:

Category:

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