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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.

Keywords

Drug Product Stability Study Critical Activity Packaging System Full Testing 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer Science+Business Media, LLC 2009

Authors and Affiliations

  1. 1.PharmalytikNewarkUSA

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