Testing Services under 21 CFR Part 610

Protheragen-ING Lab is dedicated to providing comprehensive testing services that ensure the safety, efficacy, and quality of biologics and medical products in strict compliance with 21 CFR Part 610. Our team of experienced professionals is committed to upholding the highest standards of regulatory compliance and delivering reliable, data-driven results to our clients.

Our comprehensive testing services

Under 21 CFR Part 610, the FDA has established rigorous standards for biological products to ensure their purity, potency, safety, and efficacy. Our testing services cover a wide range of requirements under these regulations, including but not limited to:

• Sterility Testing

Ensuring that biological products are free from viable contaminating microorganisms is critical for patient safety. We perform rigorous sterility testing using validated methods to comply with regulatory standards.

• Purity Testing

The presence of impurities can compromise the safety and effectiveness of biological products. Our comprehensive purity testing identifies and quantifies contaminants, ensuring adherence to specified purity requirements.

• Potency Testing

Potency tests are essential to confirm that a biological product performs as intended. We conduct various assays to measure the biological activity of products, ensuring they meet potency specifications.

• Safety Testing

We offer a range of safety tests, including those for pyrogens and endotoxins, to detect substances that could cause adverse reactions. These tests are vital for confirming that products are safe for use.

• Identity Testing

Confirming the identity of a biological product ensures it is correctly labeled and authentic. We utilize advanced techniques to verify product identity and compliance with labeling standards.

• Stability Testing

Stability testing is crucial for determining the shelf-life and proper storage conditions of biological products. Our stability studies are designed to assess the product's quality over time under various environmental conditions.

Our commitment to quality

Protheragen-ING Lab is committed to maintaining the highest standards of quality in all aspects of our operations. Our team of scientists and technicians are extensively trained in the latest testing methodologies and regulatory requirements.

We adhere to rigorous quality management systems, including:

• Compliance with 21 CFR Part 11 and 21 CFR Part 610 regulations.
• Implementation of cGMP and cGLP practices.
• Continuous staff training and development.
• Ongoing equipment calibration and maintenance.
• Comprehensive data integrity and documentation controls.

Our clients

Our clients include leading pharmaceutical and biotechnology companies, as well as research institutions and government agencies, who trust us to provide reliable and compliant testing services. We take pride in our long-standing relationships with our clients and our ability to adapt to their evolving needs.

To learn more about our 21 CFR Part 610 testing services or to discuss your specific requirements, please don't hesitate to contact us. Our team of experts is ready to assist you in ensuring the quality and safety of your biologics and medical products.