Stability Operation Practices
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.
KeywordsDrug Product Stability Study Critical Activity Packaging System Full Testing
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- 1.Immel BK (2000) A brief history of the GMPs – the power of storytelling. BioPharm 3 (8) 26–36Google Scholar
- 2.International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (2002) Bracketing and matrixing designs for stability testing of new drug substances and products Q1D.Google Scholar
- 4.Henson E (2005) Conducting effective annual product review. J GXP Compliance, 6 (2):15–23Google Scholar
- 5.Barron, M (2003) Implementing successful stability testing operations. Pharm Tech 6(3), 14–21Google Scholar