A system of documentation must be in operation in the radiopharmacy department, allowing the traceability of each preparation, starting from the prescription through to the administration of the individual patient doses.
Instructions and Standard Operating Procedures (SOPs) should be written and independently approved for each procedure or activity carried out in the department. Specifications should be available for each raw material used as well as for the finished radiopharmaceutical. A specification for a raw material might contain details of its quality or chemical purity, while a specification for a finished radiopharmaceutical would contain details such as the radiochemical purity and sterility. See photo of product specifications.
Record keeping of ordering of radiopharmaceuticals
Records should be kept of:
- purchase and receipt of all ingredients and excipients
- purchase and receipt of radioactive products. See example. A stock record should be maintained that records the use of the various radiopharmaceuticals.
- generator elution: activity (date, time), molybdenum-99 break-through and, if tested, aluminum ion breakthrough. See an example of the records kept for generator elution.
- product preparation: batch numbers, activity and volume added, results of quality control and release
- laboratory cleaning and maintenance
- equipment calibration and maintenance. See example of records.
- training of personnel
- transport of radioactive materials to other hospitals: each consignment must be accompanied by a transport document. The regulations governing the transport of radioactive materials are extensive and vary from country to country.
- radioactive contamination monitoring (a record of counts before and after cleaning a spillage in the work area for instance) and radioactive waste disposal (solid waste arising from use of longer-lived radioisotopes for instance)
- product defects and events of non-conformity to SOPs
- patient doses. See example records.
- microbial monitoring - The environment is monitored using nutrient agar plates which are placed in the work area for a certain length of time and then incubated and inspected for microbial growth.
Apart from the documentation generated by the personnel of the radiopharmacy, relevant information on radiopharmaceuticals, equipment and procedures should be available in every radiopharmacy in the form of:
- package leaflets from the generator, labelling kits and radiopharmaceuticals purchased in ready-to-use form. See examples.
- equipment manuals. See examples.
- books (on radiopharmaceuticals, nuclear medicine, radioactivity measurement, pharmaceutical procedures, etc). See examples.
- Radiopharmacy and Nuclear Medicine journals. See examples.
- information from radiopharmaceutical manufacturers. See examples.