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ACD/Labs Blog

In pharma, drug substances (and the resulting formulated drug products) must conform to a variety of quality specifications in order to be approved for use by healthcare practitioners and patients. While most of us who have worked in pharma know the various regulatory statutes and advisory guidance (and can quote them chapter and verse!), my belief is that there is a challenge in the practical and efficient implementation of quality practices that support conformance. When considering the increasing ‘fracturing’ of supply chains that support demand for drug substances in both clinical and healthcare systems worldwide, this challenge only continues to grow.