Quality is at the core of radiopharmaceutical development and manufacturing. CPDC’s quality assurance and quality control services help you to implement or upgrade quality systems and ensure your operation always complies with the most stringent national or international standards. We can quickly and cost-effectively assess and develop strategies that will enable your facility to consistently produce high-quality radiopharmaceuticals according to good manufacturing practices (GMP) and other industry best practices.
Focused on PET and SPECT diagnostic and therapeutic radiopharmaceuticals, our quality team brings unrivaled experience and expertise in every aspect of quality control and quality assurance. This includes the knowledge we’ve gained in upgrading, building and operating our own world-class cyclotron and radiopharmaceutical manufacturing facilities.
Quality Control Services
- Drug product and drug substance testing including:
- Chemical and physical – HPLC, LC-MS, GC, radiometric analysis, etc.
- Microbiological – Sterility, endotoxins, growth promotion, identification of microbial isolates, etc.
- Analytical method development and transfer
- Method validation according to ICH Q2 standards
- Raw materials testing and validation
- Establishment and validation of finished product specifications
Quality Assurance Services
- Quality audit of GMP PET facilities and systems
- Review and refinement of process validation plans
- Review and refinement of method validation plans
- Review and refinement of GMP facility and infrastructure designs
- Design and implementation of standard operating procedures
Contact us today to discuss your quality control and quality assurance needs.
905.525.9140 x 21212