Designing Robust GMP Strategies for Radiopharmaceutical Manufacturing Under 211 Expectations
- Examining how teams are building processes based on PET (212) experience, while being assessed against stricter 211 standards, and what this means for facility design, validation, and audit readiness
- Exploring key challenges such as pressure cascades, isolator design, and operator protection vs product sterility; and how to design systems that satisfy both
- Strategies for building robust upfront controls to compensate for limited product testing windows