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Category Archives: CQA

QbD and Evaluating ‘What-If’ Drug Manufacturing Scenarios

In recent posts on the topic of Quality by Design and drug manufacturing, we referenced (here, here and here) the importance of being able to reduce unanticipated challenges by developing…

Posted in API synthesis, APIs, Chemistry, CMC, Contract Manufacturing, CQA, critical reaction parameters, Design of Experiment, FDA, Impurity profile, Neuland Labs, process chemistry, QbD, Quality | Comments Off on QbD and Evaluating ‘What-If’ Drug Manufacturing Scenarios