The literature review presented in this chapter describes the DOT certification programs and how they were developed in different ways, in part due to the flexibility found in 23 CFR 637B. Included is ...

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This article discusses reduced sampling and testing of starting materials or components. Different strategies are presented to reduce the workload at the steps from sampling to release. Viewpoints ...

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A simplified process flow with associated definitions for pharmaceutical sampling and testing is proposed. For pharma companies and regulators to have meaningful discussion on the results of analyses, ...