Stage-Appropriate Quality Systems development comes up directly or indirectly in essentially all our client work. Quality Management is essential for emerging biopharma companies in particular, who face significant technical, scientific, clinical, and operational uncertainties. There is always a question of how much, and how soon?

We see some companies ‘build for success’ who then must pivot after experiencing a clinical or regulatory setback. We see other companies take a minimalist approach until PAI or even later.

Our latest Innovators Series webinar focused on this topic of how to design and construct a Stage-Appropriate Quality System. Experts discussed what the term means, and how to build a Quality System that fits their stage of growth and maturity.

Importance of a Stage-Appropriate Quality System

At our recent webinar, Melanie Cerullo from Arranta Bio discussed the current risk-based approach to cGMP and Quality, where the focus is on scientific approach to product quality (ICH Q8), risk management (ICH Q9) and integrated Quality Systems (ICH Q10). A company at any stage in the product development and commercialization lifecycle can apply these concepts (graphic courtesy of PDA).

She clearly articulated the interaction between cGMP and CMC. CGMP sets standards and practices for manufacturing, and CMC defines critical requirements and controls for your specific products and processes.

Converge’s CMC practice leader presented on Quality System evolution, highlighting how compliance is not the best route to Quality. He also drew important distinction between the appropriate evolution of Quality System controls for the more innovative treatments and processes we see in many of our emerging clients versus that required for traditional pharmaceutical development.

Key Takeaways

Throughout the presentations, expert interviews, and attendee Q&A, insightful themes emerged.

Align Quality System Development with your Growing Level of Process Understanding

Both speakers emphasized the need to add appropriate controls as knowledge increases through product and process development. For example, early in development, when knowledge of characterization and critical parameters is limited, controls should focus on ensuring accurate data and managing constantly changing documentation and practices. In later clinical and commercial stages, the focus shifts towards controls that ensure product integrity, patient safety, and risk management.

One Size Does Not Fit All

Ms. Cerullo emphasized the role of the CMC team in setting the pace of Quality System development even before Phase 1 studies begin. This occurs when they define critical parameters and develop appropriate analytical methods specific to your unique product and processes. Quality leadership at emerging companies often makes the mistake of force-fitting a Quality System brought over from their last company.

Stay Close to the Action

The most effective Quality teams early on contain a few hands-on professionals who know the science underlying the product and manufacturing processes. We pointed out that this enables Quality to stay aligned as process knowledge increases. Over time, specialists can be brought in to optimize activities within the Quality function. Ms. Cerullo encouraged attendees to stay hands-on even in light of pandemic restrictions and the ability to complete work remotely.

Contact us at info@convergeconsulting.com at any point if you would like access to the webinar recording or a deeper Quality System conversation.