The Rules of Good Preparation (NBP) of radiopharmaceuticals for nuclear medicine are published in the Italian Gazzetta Ufficiale n° 168 del 21 Luglio 2005”, as Supplement I to the XI edition of the Pharmacopoeia of the Italian Republic and entered into force in July 2011.
They apply to all preparations of radiopharmaceuticals that are used for purposes of diagnosis or treatment. The Nuclear Medicine Departments, where synthesis and/or preparation of radiopharmaceuticals occurs, must therefore ensure the implementation and maintenance of a system in which all stages of the preparation of radiopharmaceuticals are controlled and created in response to the quality requirements required by the standard .
In the introduction (General Considerations) of the rules of good preparation of radiopharmaceuticals for nuclear medicine, it is reported that “Radiopharmaceuticals are drugs and therefore must meet the requirements of quality, safety and efficacy. The quality imperative for the safety and efficacy must be ensured by a system of quality assurance that yields consistently a product which conforms to predetermined specifications. ”
The offered training courses are designed to address the requirements for the establishment and maintenance of an appropriate system of Quality Assurance through regulatory insights, practical examples and case studies. Examples of covered topics are:
- Tools of the Quality Assurance System, with emphasis on:
- Document management standards
- Management of Changes
- Management of non-compliance
- Management of the instrumentation
- Materials management and supplier qualification
- Approach to the qualification and validation of equipment and environments.
- Maintenance of classified environments through the use of dedicated tools and materials.
- Risk assessment in microbiological validation of classified environments.
- Insulation technology and management of an insulator.
- Validation of aseptic processes: media fill tests.