By Kim Huynh-Ba* - Managing Director - Pharmalytik, LLC and Chris Latoz - Stability Manager - Hollister Incorporated

Published in: American Pharmaceutical Review

Published on: June 23, 2021

Abstract The purpose of a Stability Program is to support the expiration dating of pharmaceutical products, medical devices, and biologics and recommend storage conditions. These products are manufactured and placed in special environmental chambers (stability chambers) with specific temperature and humidity conditions according to the ICH Q1A (R2) guideline. Samples are then withdrawn and tested at various time intervals, according to specifications. Stability data are generated throughout the product lifecycle to support development, commercialization, distribution, and even transportation. The stability data sets are part of regulatory submissions; thus, any deviation or investigation may cause sample integrity concerns. According to the FDA, WHO, and various global guidelines, the temperature and humidity of the stability chambers must be accurately controlled to specific tolerances. Excursions must be evaluated and investigated if they exceed 24 hours in duration and if there is any impact on the quality of the products, additional actions may be necessary. This paper will provide some key factors to consider regarding how temperature and humidity excursions to stability samples should be investigated and what data is needed to support conclusions about sample viability. This article may also be of interest to the chamber management group of the Stability Program and those involved with facility management. Various suggestions can be incorporated into a company’s internal standard operating procedure (SOP) to handle deviations and protect the integrity of products stored.

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