Operational Excellence and Process Evaluation In Pharmaceutical Manufacturing

The objective of this study is to unify understanding of the concepts of Operational Excellence and Process Evaluation in non-sterile solid dosage form manufacturing and to identify the potential cause of problems. It is becoming widely recognized in the pharmaceutical industry that a more structured approach to process development would benefit the quality of the developed process to ensure added value to the products in long term. Building reliable process models would help to save resources in the long term by providing answers to process issues, reducing the trial and error aspect and introducing the opportunity for optimization.

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