Quality Control and Quality Assurance

Quality is at the core of radiopharmaceutical development and manufacturing. Focused on PET and SPECT diagnostic and therapeutic radiopharmaceuticals, our Quality Assurance team brings unrivaled experience and expertise in every aspect of quality assurance. This includes the knowledge we’ve gained in upgrading, building and operating our own world-class cyclotron and radiopharmaceutical manufacturing facilities. CPDC Quality Assurance team works closely with our non-clinical, product development, and manufacturing groups and is fully integrated with the Clinical Research and Regulatory Affairs departments, providing a streamlined approach from development to commercial manufacturing.

CPDC’s Quality Assurance services can 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.

Our team includes staff with the following skills and background:

  • An in-depth knowledge of GMPs.
  • Quality training and advanced degrees in scientific disciplines.
  • Extensive experience working in industry, including multi-national pharmaceutical and radiopharmaceutical companies.

The Quality Assurance team prides itself in maintaining a high level of quality due to our comprehensive systems and thorough approach to projects.

 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 audits of manufacturing facilities and quality systems
  • Hosting quality audits
  • Review and refinement of process validation and stability plans
  • Review and refinement of method validation and transfer plans
  • Review and refinement of GMP facility and infrastructure designs
  • Review of equipment qualification, maintenance and calibration plans
  • Design and implementation of core quality systems
    • Including, but not limited to, Document Control, Change Control, Non-conformances, CAPA, Materials Management, Batch Release
  • GMP training workshop
Contact us today to discuss your quality control and quality assurance needs.

905.525.9140 x 21212