Final Product Release Testing

Every lot of product produced, both for preclinical and clinical studies, requires a series of tests to ensure active ingredients are free of contaminants according to 21 CFR 211 165 and 21 CFR 610. All biologics being released into the global pharmaceutical markets require GMP testing of final product packages to demonstrate compliance with regulatory guidelines

We offer a wide range of assays and services for final product release testing:

• Sterility Testing
• Residual DNA
• Endotoxin Detection, LAL Test
• Comarability & Lot Release Testing
• Method Transfer & Validation

Contact an expert about Final Product Release Testing and Custom Final Product Release Testing.