GMP Stability Testing & Storage
GMP stability testing determines how a drug product performs under routine and stressed conditions. Prolytix performs GMP‑compliant stability testing and provides ICH‑compliant storage to support clinical and commercial drug products.
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To move a drug product from discovery to regulatory approval and commercial manufacturing, it is essential to understand how the product performs under a wide range of conditions. Prolytix performs all drug stability testing under strict GMP compliance in an FDA‑inspected facility.
Prolytix implements real‑time and accelerated stability programs and supports shelf‑life determination using client‑defined, compendial, or in‑house developed and validated methods.
ICH‑compliant GMP storage is available on‑site under a wide range of temperature and humidity requirements to maintain product integrity.
