Radiopharmaceuticals
Expert GMP Oversight for Radiopharmaceuticals
Specialist GMP expertise for PET tracers and radiolabeled medicines — from cyclotron to patient.
Radiopharmaceuticals play a critical role in modern diagnostics and therapeutic monitoring, and their manufacturing is subject to some of the strictest regulatory controls in the pharmaceutical industry. With more than 20 years of QA expertise, I offer unparalleled experience in the GMP-compliant manufacturing, quality control, and auditing of both PET tracers and radiolabeled medicines used in clinical and commercial settings.
PET Tracers: short half-lives, fast decisions
PET tracers are radiolabeled small molecules that enable real-time imaging of biological targets, manufactured under 21 CFR Part 212, Eudralex Volume 4 Annex 3, and USP <823>. Synthesis must be fast and precise due to the short half-life of the isotopes.
More about PET tracer compliance →Radiolabeled medicines: broader applications, longer half-lives
Radiolabeled medicines (e.g. used in mass balance studies) often involve isotopes such as lutetium-177 or zirconium-89 with longer half-lives, manufactured under Eudralex Volume 4 standards with extensive QP oversight.
More about Human Mass Balance (AME) →Key insights
- GMP manufacturing of PET tracers must balance sterility, speed, and regulatory acceptance — with validated processes, qualified equipment, and auditable traceability.
- Auditor expertise in PET manufacturing ensures that high-risk steps such as sterile filtration, endotoxin control, and documentation for investigational use are fully compliant with FDA, EMA, and national agencies such as FANC.