PDA TR 56 (Revised 2026): What phase-appropriate GMP should look like in practice
TR 56 was revised in 2026, and the key question is no longer “At what point do we need GMP?” It is “What must be robust now, and what can mature later?” Watch Tamar Oved, PhD translate the guidance into 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. 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. For many teams, the update also sits directly at the interface of execution and CMC regulatory affairs, where early decisions quickly become difficult to unwind.
A hybrid model often delivers the best of both worlds. Run a lean Israeli engine to reach first-patient data and pair it with one or two U.S. sites for KOL engagement and downstPhase-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.ream regulatory alignment
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 TR 56 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
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. Our work often supports sponsors and CDMOs across biopharma regulatory consulting and CMC regulatory affairs, alongside operational quality system execution.
