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Abstract

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.

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Correspondence to Kim Huynh-Ba .

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© 2009 Springer Science+Business Media, LLC

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Huynh-Ba, K. (2009). Stability Operation Practices. In: Huynh-Ba, K. (eds) Handbook of Stability Testing in Pharmaceutical Development. Springer, New York, NY. https://doi.org/10.1007/978-0-387-85627-8_15

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