Course Description

This training program explores the world of radiopharmaceutical manufacturing, blending practical sterile production techniques with the regulatory expectations that shape every step. You will move from understanding what radiopharmaceuticals are, through facility design and aseptic processing, to quality control, documentation, and the release of both conventional and positron-emitting products. The material brings together the key requirements from FDA, Health Canada, European Union, and USP standards, highlighting how they converge and where they differ. Real-world examples and case-style questions help you connect the rules to daily operations in nuclear pharmacies, hospital radiopharmacies, and commercial manufacturing sites.

Scope

The program covers the full manufacturing lifecycle for sterile and non-sterile radiopharmaceuticals, including PET drugs, radionuclide generators, kits, and compounded preparations used in research, clinical trials, and routine patient care. It addresses definitions and classifications; facility and engineering controls; production processes; quality control testing; labelling and distribution; documentation and release; investigational products; and sterile compounding practices under USP standards and national regulations.

Target Audience

• Nuclear pharmacists and radiopharmacists working in hospital or commercial settings.
• Quality assurance and quality control professionals in radiopharmaceutical manufacturing.
• Production supervisors and operators in PET centres or nuclear medicine departments.
• Regulatory affairs specialists dealing with radiopharmaceutical submissions.
• Inspectors and auditors assess GMP compliance at facilities that handle radioactive drugs.
• Trainees entering the field of radiopharmacy and nuclear medicine technology.

Regulatory References Used to Design This Course

• U.S. FDA: 21 CFR Part 210, Part 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals), Part 212 (CGMP for Positron Emission Tomography Drugs), Part 312 (Investigational New Drug Application), Part 361 (Radioactive Drugs for Certain Research Uses).
• United States Pharmacopeia: General Chapters 〈797〉 (Pharmaceutical Compounding – Sterile Preparations), 〈825〉 (Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging), 〈823〉 (PET Drugs for Compounding, Investigational, and Research Uses).
• European Commission: EudraLex Volume 4, Annex 3 (Manufacture of Radiopharmaceuticals).
• Health Canada: Good Manufacturing Practices Guide Annex 3A (Schedule C Drugs) and Annex 3B (Positron Emitting Radiopharmaceuticals).

Certification

Learners who successfully complete the program will receive a dated, traceable certificate that provides verifiable proof of their achievement for professional records.