PCM and Quality: Upgrade Your Resolution

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In process development of a Pharmaceutical Continuous Manufacturing (PCM) oral solid dose (OSD) drug product, the goal is to identify all sources of variation and their impact on the quality of the final product. Implementing measures to properly mitigate or compensate variation will assure all product that goes to the patient is within pre-established quality specifications. This set of measures is called a control strategy and it considers the dynamic nature of a continuous process.

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