Phase-appropriate GMP – how should it look like in practice

This webinar, triggered the revision of PDA TR56 that was revised in 2026, demonstrate the shift of questions, from “At what point do we need GMP?” to “What must be robust now, and what can by mature later?” Watch Tamar Oved, PhD explaining the practical, phase-appropriate execution.

PDA Technical Report No. 56 is a long-used reference for phase-appropriate quality systems and GMP for biological drug substance. The 2026 revision of this guideline triggered this overarching webinar, relating to GMP implementation at different development phases. For sponsors and CDMOs, the practical goal is to build a fit-for-purpose quality system that supports safe clinical supply and scales as programs accelerate, without overbuilding early systems.

The core message

Phase-appropriate does not mean minimal. It means structured and risk-based.

As product and process knowledge increases, rigor and documentation should step up in a deliberate way. This matters even more when timelines compress. Expedited pathways and parallel activities often require stronger controls earlier than teams planned.

What teams should revisit now

In the webinar, Tamar highlights where teams commonly underbuild early and then pay for it later through comparability questions, and quality system catch-up.

1. Quality risk management that drives decisions

Risk assessments work best as a lifecycle tool. Use them to set control strategy now, and to define clear triggers for step-ups in rigor later.

2. Sponsor oversight when work is outsourced

Outsourcing does not outsource accountability. Even when manufacturing and testing sit with a CDMO, the sponsor remains responsible for key quality decisions, oversight, and release readiness.

3. Documentation and data integrity

Early development data becomes foundational faster than teams expect. Weak documentation and data integrity early often creates painful reconstruction later when decisions, changes, and continuity must be justified.

4. Method lifecycle, specifications, and comparability planning

Methods and specifications evolve across phases. The practical goal is to plan that evolution so method changes, tightened criteria, and shifts in testing strategy do not create avoidable comparability issues.

Practical next steps checklist

Use these questions to translate the phase-appropriate approach into execution:

• Are the basics in place before Phase 1 (controlled records, documentation practices, calibration and maintenance)
• Do we have a risk approach that is proportionate now and scalable later?
• Is sponsor oversight of outsourced work clearly defined (quality agreement, escalation paths, release responsibilities)?
• Can we trace key development decisions and changes without reconstructing history?
• Do we have a plan for method qualification and validation by phase, including how method changes will be managed?
• Do we have a comparability plan as the process evolves, with clear triggers for deeper studies?
• Are quality system upgrades aligned to the program’s realistic pathway, including potential acceleration?

Watch the 45-minute session to get the practical takeaways and a clear execution approach.

Speaker

Tamar Oved, PhD – QA and CMC Director, ADRES Advanced Regulatory Services

About ADRES

ADRES provides international biotech consultation and execution, with integrated regulatory, QA, and CMC support to help teams build phase-appropriate systems that meet current expectations from early development through later phases.