Publication

Manufacturing compliance: an emerging topic In life science companies' boardrooms

A version of this article was first published in Chemical Market Reporter October 2002.  You can proceed to order it – at no charge – by clicking on the ‘Request publication’ button

Manufacturing compliance has historically been an overlooked issue within the life sciences industry. However, recent high-profile cases, notably blockbuster product launch delays and plant shutdowns, have brought this topic to the forefront for both the general public and senior life science executives.

While the cost of manufacturing compliance can be as high as 25 percent of a manufacturing site's total operating budget, the total cost incurred by a company, notably the loss of revenue, public perception and stock market valuation as a result of manufacturing compliance problems is undoubtedly significantly higher.

To achieve success and emulate best practices, senior management must develop a robust framework for manufacturing compliance. The program requires a proactive and comprehensive approach where compliance-related issues are addressed aggressively and strategically.

The two main components of this program are proactive risk management and measuring against goals. With a comprehensive program and senior-level leadership, companies can achieve greater competitive advantage, lower costs, and improved shareholder value through excellence in manufacturing compliance.