According to the cGMP requirements for producing the radiopharmaceutical product, there is a necessity for designing the production facility to meet the regulatory expectation (i.e. European or USDFA in addition to local requirements). At PharMatrix we can provide complete support for the following activities:
- Design Support: the design of the facility is important to achieve pure and efficient product and to assure it is produced within the cleanroom facility and avoid any contamination or cross-contamination, we can provide support for radiopharmaceutical facility design, equipment, and other utilities and infrastructure.
- Qualification and Validation: We can provide the Qualification and Validation support to your cleanroom facility and equipment in addition to the relevant utilities (HVAC, BMS, Clean Gases, Water System as well as Environmental monitoring system and Computer Software Validation). This support includes protocols preparation, execution, performing the calibration, in addition to performing the room air balance if required. Furthermore, we can provide and support the preparation of the sterility assurance protocols as well as media fill programs to make sure your facility copes with local requirements and meets the regulatory expectations.