The IMPALA consortium is an engine of practical innovation, assembling expert teams to tackle high-priority challenges in the biopharmaceutical quality domain. These work product teams translate collaboration directly into impact, producing concrete, deployable assets like open-source software, novel methodology frameworks, and definitive guidance for immediate use.

  • GenAI Validation Guidance

    With the increasing use of Generative AI in the pharmaceutical industry, and the evolving regulations and guidance from various regulatory authorities, IMPALA aims to outline some key principles and guidelines helping the industry to adopt GenAI while assessing the risks and establishing the right controls to ensure safe use.

  • Critical to Quality Assessment

    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.

  • RAPID Audit Methodology

    Real-time Audit Package informed by Data (RAPID) is a data-driven approach that follows a pre-defined methodology to assess processes and identify systemic issues efficiently.

  • GenAI for Audit Report Drafting

    New workstream focused on leveraging Generative AI (GenAI) to support the drafting of audit findings . This initiative is part of a broader shift from exploratory discussions to structured implementation of GenAI in quality assurance.