Positron Emission Tomography (PET) is a cornerstone of modern diagnostic imaging, allowing for non-invasive, real-time visualization of physiological processes. The tracers used in PET — typically radiolabeled small molecules — must be manufactured and controlled with speed, sterility, and full regulatory compliance. Their short half-life, limited stability, and need for immediate use make PET tracers among the most technically demanding radiopharmaceuticals to produce.
With a strong background in GMP auditing, compliance consulting, and radiopharmaceutical QA, I bring deep expertise in the manufacture, quality control, and release of PET tracers used across clinical research and diagnostic imaging — including products like Amyvid®, custom amyloid ligands, and fluorine-18 or carbon-11–based tracers.
Complex Products, Streamlined Oversight
The production of PET tracers typically follows a 3-step process:
- Cyclotron-based isotope production (e.g., [¹⁸F], [¹¹C], [¹⁵O]) – non-GMP raw material step
- Automated synthesis and sterile filtration – this is the GMP-critical step
- Dispensing into patient-specific vials and on-site injection – final preparation and use
The core of my expertise lies in auditing and validating GMP step 2 operations:
- Automated synthesis in hot cells
- Use of validated kits, traceability, and aseptic dispensing
- Sterility assurance under time constraints, including provisional QP release procedures before full sterility data are available
This release-before-sterility model, while unusual, is fully accepted by regulators under 21 CFR Part 212 (US) and Eudralex Volume 4, Annex 3 (EU). I have successfully audited PET facilities across North America and Europe, ensuring these practices meet the expectations of local competent authorities, sponsor QA teams, and compound-owners such as Avid/Eli Lilly.
Key Takeaways
✅ GMP manufacturing of PET tracers must balance sterility, speed, and regulatory acceptance—requiring validated processes, qualified equipment, and auditable traceability.
✅ Auditor expertise in PET production ensures that high-risk steps like sterile filtration, endotoxin control, and documentation for investigational use are fully compliant with FDA, EMA, and national agencies like FANC.
Want Your PET Manufacturing Audit-Ready?
If your facility produces or licenses out PET tracers, you need an expert who understands GMP intricacies specific to short-lived radiopharmaceuticals. I offer audits, gap assessments, and quality system reviews that are practical, timely, and inspection-ready.
📩 Contact me today for expert support in PET tracer compliance and GMP manufacturing.