EU GMP Annex 3 - Manufacture of Radiopharmaceuticals

What it says

Manufacture of radiopharmaceuticals requires GMP principles adapted for the unique constraints of radioactive materials, including short product shelf lives often measured in hours, radiation protection requirements for personnel, and specific considerations for facility design and quality control testing that must often occur after release due to rapid radioactive decay.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Radiopharmaceuticals present a genuinely unique manufacturing challenge: extremely short shelf lives, sometimes just hours, can mean quality control testing is completed after the product has already been administered to a patient, requiring specific risk-based control strategies to manage this timing reality.
• Radiation protection for personnel is a specific, additional safety dimension layered on top of standard GMP contamination control expectations, requiring facility design and procedures that address both product quality and personnel radiation exposure simultaneously.
• The very short timelines involved mean this annex places particular emphasis on process validation and in-process control as the primary quality assurance mechanism, since traditional finished-product release testing before distribution is often not practically possible.

What inspectors look for

• Whether control strategies genuinely account for the reality that some testing may complete after product administration, with appropriate risk-based justification for this approach.
• Whether radiation protection measures for personnel are integrated with, rather than separate from, the facility's broader contamination control and GMP compliance programme.
• Whether process validation carries the primary quality assurance burden appropriately, given the practical limitations on traditional pre-release testing for extremely short shelf-life products.

Related regulations