By Kim Huynh-Ba, Chris Latoz
Published in: American Pharmaceutical Review
Published on: June 1, 2024
Expiration dating and storage conditions are required on the label for all pharmaceutical products. To establish a drug product’s storage condition and expiration date, a manufacturer must conduct stability studies for all phases of the drug product, from clinical trials to manufacturing and continuing after approval. Stability studies are quality assessment tools to ensure that any chemical, physical, or microbiological changes that may occur as the product ages will not adversely impact the quality of finished products throughout the product’s lifetime. Stability data are also used to establish product specifications to monitor drug product quality, safety, and efficacy. ICH Q1A(R2) is an excellent resource for selecting the appropriate requirements for a stability program; however, ICH is a guideline for new drug substances and drug products; therefore, it is insufficient for acquiring complete knowledge of the stability behavior of a drug product. ICH Q12 has introduced the concept of product lifecycle management, in which post-approval changes are also considered to maintain and improve quality and where knowledge gained throughout the product lifecycle can provide a better understanding of the risks to the stability program. This paper will discuss how the ICH Q12 concept can be built into the stability program and how the Q12 toolbox can connect stability activities supporting product and process changes continuously from the design phase through post-approval, thus fostering continuous improvement for the entire product lifecycle.
