GMP Release Testing
GMP release testing is a critical quality control process that ensures manufactured therapeutics meet predetermined specifications before release. Prolytix provides GMP release testing for clinical and commercial drug substances and drug products.
GMP release testing involves physical, chemical, and microbiological tests to confirm that manufactured therapeutics meet predefined specifications. Prolytix performs GMP release testing on bulk, final product, and in‑process materials.
Testing is conducted in a fully compliant, FDA‑inspected facility using validated analytical methods and predefined GMP release testing protocols.
These services support product quality and regulatory compliance from early clinical development through commercial release.



