The pharmaceutical business is in transition as the formula for success relying solely upon new drug development and time to market is being challenged. Global competition, reduced patent protection, the rising cost of drug development, sociopolitical pressure for more affordable and available life saving drugs, and FDA initiatives require a business model placing greater emphasis on manufacturing performance.
Improving manufacturing efficiency and meeting current and evolving regulatory requirements demands that the manufacturing automation architecture and employment of best practices across the enterprise become strategic initiatives. Cost and time to validation still play a critical role in time to market and potential loss of millions of dollars of revenue.
But manufacturing performance, either in-house or contracted, and responding to FDA requirements in the face of stepped up enforcement policies have become critical to business success and even business survival.