The purpose of a stability program is to study how the quality of a substance or product varies with time under the influence of environmental factors, such as temperature, humidity, and light, and to establish a shelf-life, packaging configuration and recommended storage conditions.
The choice of tests, conditions, and frequencies is a complex process that requires intimate knowledge of the interplay between the critical process attributes that define the final product. Additionally, statistical methods are used to analyze the data; thereby, assuring the quality will be maintained within the optimum storage condition and shelf-life.
We provide support in the following areas
Statistical Data Analysis
OOS and OOT investigations
The stability protocol is a key document outlining the overall program design. The content of the protocol should be created based on the behavior and properties of the substance, results from other studies, and experience. The protocol should include test methods, which are qualified to detect changes in the quality, safety, and/or efficacy of the product.
Validated stability-indicating analytical procedures should be selected for the program. These methods should adequately demonstrate the capability to detect changes in the key quality attributes of the product as a function of time. Designing and validating these types of methods are quite challenging and frequently require input from a chemistry expert to meet the demands of the study.
An approach for analyzing data on a quantitative attribute that is expected to change with time can be performed by applying appropriate statistical tests. This can be quite involved and may require several interim steps, such as data transformation, to adequately describe the quality relationship to time. This evaluation is best done by a qualified statistician with a background in chemistry so that a thorough explanation of the data is provided.