When To Conduct GMP Versus Non-GMP Stability Studies — And Why Both Matter

By Bodo Brocks, Head of Quality, and Andrea Hawe, Chief Scientific Officer

Stability studies are an integral step to determining how a drug’s quality, safety, and efficacy evolve over time when exposed to different environmental conditions such as temperature, humidity, and light. These studies — which are required by regulators and include forced degradation, in-use, long-term, accelerated, and shipment studies — provide data to support shelf-life claims, shipping and storage requirements, formulation choices, and long-term development strategies.

Stability studies are performed under both GMP and non-GMP conditions, with each approach providing distinct value throughout the product lifecycle. GMP studies are a quintessential component of scaleup, commercial manufacturing readiness, and clinical trial activation. Meanwhile, non-GMP studies inform the early stages of product development: guiding candidate selection, formulation strategy, risk mitigation, and regulatory approaches. With a better understanding of when to leverage each type of study and how to bridge the resulting data, sponsors can strengthen their early development effort and ensure speed to clinic. Download the full article to explore the value of both GMP and non-GMP stability studies.