BIOTECH BUSINESS CONTINUITY AND RECOVERY STRATEGIES.

Business continuity planning (BCP) is put into action by companies to prevent disruptions in operations. In the area of pharmaceutical and biotech manufacturing, it is extremely critical that raw materials are received in a timely manner to prevent disruptions in manufacturing, and potentially preventing life saving treatments from getting into the hands of those who need it. However, manufacturing provides challenges to accurately complete business continuity planning. The evaluations must include all facets of the supply chain, from suppliers of raw materials to components used to create the end product; a supplier's disasters can become a customer's disasters.

Historically, manufacturers approached business continuity planning by using the requirements set by their suppliers, typically based on worst-case scenarios. Planning for the worst-case scenario can result in tying up millions of dollars for inventory that may never be needed. Increasing financially-based pressures on cash flow, has evolved this methodology in recent years. The approach being applied today involves evaluation and ranking of risks which may occur, and planning for those which are the most likely.

Improving a company's risk management strategy and strengthening their response to threats and disasters does not have to be overwhelming.1 If managed properly, a business continuity plan can give a company a flexible and focused framework for addressing various risks simultaneously and one that involves all critical business units in the design and execution of the plan.1

Millipore has developed and implemented plans designed to anticipate and minimize interruption to key business processes, production facilities and distribution sites. Each center of excellence has implemented these policies and procedures, to ensure the health, safety and welfare of employees and ensure the continuity of supply to customers.

The approach toward potential risks and applicable continuity and recovery operations is product specific. Plans are created which document the continuity strategies, providing details on equipment, facilities, and resources needed for recovery of operations. Millipore's business continuity risk assessment process includes the review of over 90 separate risks covering technology, business process, man-made, and environmental events.

To meet emerging customer needs for a secure supply of product, Millipore maintains an active business continuity program centered on three elements: Production Reliability, Risk Assessment and Mitigation, and Crisis Management. Implementation of these principals is critical for existing products, but must also be considered for products in development as well.

Production Reliability