Accelerated conditions are important to determine the stability of a drug product prior to marketing, and prior to adoption of significant changes in formulation, manufacturing, procedures, or packaging materials that may affect the shelf life of the product.This condition is usually referred as a “back-up” storage condition in the event that an out-of-specification (OOS) result or significant stability change is identified during testing at the accelerated level.New products must also be placed on long-term stability to collect pertinent data that will help advise an expiry date.
It’s also a good idea to ensure testing is conducted at the actual (proposed or established) expiry date.
You should put a minimum of one lot per year of marketed product onto long-term stability; for each dosage strength, each size, and from each type of container/closure, to support the product’s existing expiry date.
Shelf-life testing of a drug product is a means of assessing the functionality, effectiveness, and stability of a pharmaceutical product over a period of time to either establish a new expiry date for a new product, or to collect data in ongoing support of an already-existing expiry date for a commercial/marketed product.
To challenge the lifespan of either a new or commercial drug product, it is exposed to various extremes of regulated temperature and humidity conditions for specified lengths of time, inside what are known as “stability chambers”.
The key is to catch atypical results or trends immediately, so that an investigation can be initiated to dig deeper into the issue at hand.