Why is GMP important?
The FDA continues to increase its oversight on Radiopharmaceuticals. This oversight places additional scrutiny on supply chains
As Ac-225, Lu-177 and other Radiotheranostic radionuclides come into use, the FDA will increase its oversight of the radiopharmaceuticals supply chain. Facility cGMP is the structure that the FDA uses to ensure production of high-quality, high-purity, consistent products and it is being required. It is critical that therapeutic radioisotopes are pharmaceutical grade with cGMP manufacturing to avoid impurities that can interfere with therapy or harm patients.
At SpectronRx, we are anticipating the FDA’s increased oversight and only supply GMP/Pharmaceutical grade isotopes without impurities.
We take quality seriously and are dedicated to thorough preparation, execution, evaluation and quality control of every product that leaves our facility. Our highly-trained staff are knowledgeable about current GMP regulations and provide insight and depth into ensuring quality in our production, facilities, equipment, and personnel.
Quality Assurance Program
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