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Monthly Archives: July 2015

Quality Control & Assurance Are Constantly Evolving

Sometimes I feel like I come across as a bit too “QA crazy,” but quality in the pharma sense isn’t really something of which you can have too much. From…

Posted in Contract Manufacturing, FDA, Impurity profile, Neuland Labs, QA/QC, Quality | Comments Off on Quality Control & Assurance Are Constantly Evolving

API Production: Building an Impurity Profile

Impurities and the ICH Limits for Impurities Impurities are unwanted chemicals produced during normal manufacturing of Active Pharmaceutical Ingredients, or APIs. As you well know, impurities have no therapeutic value…

Posted in analytical science, API synthesis, APIs, Chemistry, CMC, Contract Manufacturing, CRO/CMO, ICH, Impurity profile, method development, Quality, regulatory | Comments Off on API Production: Building an Impurity Profile