Process analytical technology Product testing

The current regulatory climate of QbD places an emphasis on clinically relevant specifications and methods for in vitro dissolution.20 Development scientists should identify dissolution methodology that has been closely examined for its relevance to in vivo performance, as well as for mechanistic information. In other words, the release mechanism of the product should be understood and the dissolution test should be able to detect changes reflecting deviation of the mechanism. There is also the quality control (QC) side of dissolution testing, which, until the process analytical technology (PAT) develops beyond the current capabilities, is very important for stability and end-product release testing. 

Exposure of all products used in foods and food processing to foreign material contamination must be prevented. If objectionable impurities from any source, other than those covered by FCC requirements, are suspected to be present, good manufacturing practice requires the manufacturer to ensure that the substance is suitable for its intended applications as a food chemical by applying additional tests and limits. Current analytical technology should be applied wherever possible. 

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