All excipients are indispensable in a formulation, but not all of them are crucial to the design or performance of the finished product. The current approach used by pharmaceutical manufacturers to classify process parameters and quality attributes as being critical or non-critical is too simplistic to adequately reflect current science- and risk-based approaches to product quality, noted Brian Carlin, director, Open Innovation at FMC, and a CPhI expert panel, in the 2016 CPhI Annual Industry Report.

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