AUSTAR Provided Pharmaceutical Quality System and Validation Consulting Services for a Radiopharmaceutical Manufacturer

Introduction:

With the advancement of technology and the growth of demand in the pharmaceutical market, the nuclear pharmaceutical industry is experiencing rapid development. The support of national policies has also provided a favorable development environment for the research, manufacturing and application of radiopharmaceuticals. The radiopharmaceutical market shows enormous potential and growth momentum in China.

Customer Background:

As an important research and manufacturing base for radioactive isotopes and radiopharmaceuticals, the customer has been dedicated to the research and manufacturing of medical isotopes for many years. The company has significant advantages in production technology, product quality, product supply, and supporting service capabilities, and continuously carries out research and exploration in the nuclear pharmaceutical field to meet the long-term needs of sustainable development of nuclear medicines.

Scope of Services:

• EU GMP & NMPA GMP standards.

• Quality management system consulting services.

• Facilities and equipment validation consulting services.

AUSTAR Contributions and Customer Benefits:

• AUSTAR has been awarded the Certificate of Qualified Supplier by Group clients.

• Helped the client establish and improve the quality management system, which was highly recognized by Germany MAH.

• Performed EU GMP compliant facilities and equipment qualification and validation activities to guarantee reliable manufacture of radiopharmaceuticals.

• Assisted the client in complying with the manufacturing requirements of sterile products and the highest safety standards for radioactive hazard control.