With the entry into force of the Guidelines on Good Radiopharmacy Practices for Nuclear Medicine (GRP-NM), and with the Pharmacopoeia changes, it is necessary for compliance with those specifications for all private and public institutions that deal with such preparations.
The verification and demonstration of compliance to GRP-NM is developed through various stages to demonstrate that the production facility is able to ensure quality, efficacy and safety of production for a complete protection of the patient.
CTP SYSTEM, with specific expertise, can support the facilities in the GRP-NM certification through its services of design, validation, support for quality system and microbiological problems (analysis and media-fill).
CTP SYSTEM services:
- QUALITY AREA
development of quality assurance systems
preparation and review of procedures / operating instructions
risk analysis on processes and environments
process validation and media fill
QA “on demand”
- ENGINEERING AND QUALIFICATION AREA
environmental design and classifications
qualification and validationenvironmental monitoring
- LAB AREA
analytical methods validation
sterility and LAL test
supply of culture media and Media Fill analysis
Mob. +39 348 6504078