This chapter covers critical activities necessary to maintain an effective stability program. Best practices on day-to-day operational activities such as sample pulling, testing window, and chamber inventory are included in this section to provide guidance on current industrial practices. Development of a stability protocol is also integrated together with a discussion of ICH Q1D-Bracketing and Matrixing concepts.
CITATION STYLE
Huynh-Ba, K. (2009). Stability operation practices. In Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices (Vol. 9780387856278, pp. 303–320). Springer New York. https://doi.org/10.1007/978-0-387-85627-8_15
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