Quality, facilities, and personnel
SpectronRx is 100% Dedicated to Quality
Why is GMP important?
The FDA continues to increase its oversight on Radiopharmaceuticals.
This oversight places additional scrutiny on supply chains
- If you are conducting any type of IND work, radionucleic purity and consistency between your Phase I, II, III and the approved drug are critical
- SpectronRx products are manufactured under a GMP quality system to ensure a high-quality, high-purity consistent products.
- We have Radiochemists available to answer questions about the isotopes we provide.
Our Commitment to the Future
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.
Quality Assurance Program
Quality is our Lifestyle
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
- Aseptic Process
- Product Labeling
- Release Authority
- Good Documentation Practices
- Readiness for Regulatory Inspections
- Deviation Reporting
- CAPA
- Annual Product Review & Reporting
- Change Control
- Out of Specification Investigations
- Risk and Root Cause Analysis
- Material Control
- Vendor & Material Qualifications
- Equipment Maintenance, Calibration and Qualification
- Adverse Event Reporting
- Product Complaint Handling
- Pharmacovigilance
- Employee Training
- Internal Auditing
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