Jeff Gardner, B.S., is president and principal consultant at DataPharm, a consulting company providing statistical analysis and data management services to U.S. pharmaceutical and biotech manufacturers. Laura Pack, B.S., is a senior quality engineer at Amgen, where she uses over 10 years of experience to support many different types of stability analyses.
Having high-quality stability data is critical to pharmaceutical and biopharmaceutical industries around the world. These data form the basis for justifying specification limits. Specification limits are numerical limits, ranges, or other criteria for the required tests to which a product must conform in order to be considered acceptable for its intended use; these limits are filed with regulatory agencies.
The stability data, combined with the specification limits, are used to set and/or extend product expiration dates and for establishing product label storage statements. Stability studies are initiated annually and may be used to support product or process modifications. These studies are vital for ensuring the continuous quality of production batches. In order to identify potential issues quickly and to ensure data quality, it is often advantageous to use objective and statistical methods that detect potential out-of-trend (OOT) stability data. The figure here is an example of statistical tolerance limits that provide an objective means of identifying the red data point as atypical.
In the AAPS webinar Building Robust Stability Trending Programs: A Case Study, on March 13, the presenters will discuss trending of stability results for biopharmaceutical products. This presentation will provide an overview of statistical approaches for trending stability results (such as that shown in the figure above), strategies for timely response to “signals” that a stability result is OOT, and how to build a sustainable trending program. A case study of an OOT program will be presented, including its initial development, scope, calculation of trending limits, response to out-of-trend results, and challenges faced in creating and implementing the program. Finally, best practices, including suggested solutions for addressing common challenges, will be shared. Participants will learn how stability OOT programs can be optimally positioned and managed within an organization’s quality system in a fully compliant manner.