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.


Drug Product Stability Study Critical Activity Packaging System Full Testing 
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Copyright information

© Springer Science+Business Media, LLC 2009

Authors and Affiliations

  1. 1.PharmalytikNewarkUSA

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