Finding Common Ground: Factors For Establishing And Safeguarding Shelf Life In Combination Products

By Lauren Orme, Senior Director of Regulatory Intelligence and Policy

For combination products—which integrate drugs into a delivery platform—establishing a robust shelf life is a critical requirement for regulatory submission and ensuring patient safety. The shelf life is the period during which the product remains safe, effective, and suitable for its intended use.

To define a combination product's shelf life, manufacturers must conduct holistic stability studies that consider the independent and interactive shelf-life characteristics of the drug, device, and packaging. This process requires identifying the "lowest common denominator" threshold levels that are common to all elements to dictate the final shelf-life claim.

Regulators, including the US FDA, EU EMA, and ICH, rely on stability study findings to substantiate labeled storage conditions. Key standards like ISO 11607 for sterile barrier packaging and ICH guidelines for drug stability dictate the required real-time and accelerated testing. Studies must also account for all supply chain stages, from manufacturing through distribution, as environmental factors like temperature, humidity, and light exposure can influence the product's stability.

Understand the critical testing and regulatory requirements needed to establish a successful shelf-life claim for your combination product.