Tough Problems Solved

In recent years, quality assurance in manufacturing, especially in the pharmaceutical industry, has become more exacting. For example, in the U.S. – the world’s largest pharmaceutical market – the Food and Drug Administration (FDA) has completely overhauled its 25-year-old guidelines that regulate drug manufacturing, creating a more rigorous and demanding process.

In September 2004, the FDA outlined new expectations for improved pharmaceutical manufacturing practices with a clear message: The industry must minimize health risks that arise from the manufacturing process of medications. The guidelines stipulated the introduction of modern quality-assurance and control procedures with a systems-oriented approach. They also called for the application of complex risk and quality management practices, and the implementation of state-of-the-art production technologies.

The guidelines hinge on the principle of risk-sharing applied to all products manufactured at a given production site. This means that if the manufacture of a single product fails to meet all quality requirements, that product and all other products manufactured at the same site, are considered adulterated. Thus, if only one product – perhaps even a product that generates little revenue – is a high-risk item because its manufacturing process involves outdated production equipment, it could slash the revenue of an entire production plant.

In view of such risks, pharmaceutical manufacturers must implement comprehensive risk management systems and restructure their production procedures to enhance the quality of their products.

IBM’s new Pharmaceutical Production Refactoring Tool is proving to be effective in analyzing such risks. Developed by a team of scientists at the IBM Zurich Research Laboratory and industry specialists in IBM Global Business Services, the tool is a product of the IBM Value-Driven Compliance solution. This solution is designed to help transform the development, manufacturing, and supply chain operations of large pharmaceutical and biotech manufacturers.

Specifically, this refactoring tool supports pharmaceutical companies in assessing their risk exposure relative to the strict new quality requirements. It also proposes restructuring measures for the production processes in question.

The tool is based on a novel statistical method that analyzes production performance data in terms of the required quality criteria. From this, it derives an index for each source of risk, which is fed into a complex mathematical model that determines preferred sequences of corrective measures the company can take to help reduce compliance risks and enhance revenues. The model also takes budget considerations, investment plans and the physical restrictions of the production site into account. Possible corrective measures might include eliminating certain production processes, closing down a production site or withdrawing a product. The optimization model addresses both internal and external measures.

The model also can be used as a simulation engine for partial optimization of processes and profitability, relying on sophisticated mathematical acrobatics to deliver rapid, reliable calculations. A case involving, for example, 50 product families can be assessed in just a few seconds.

IBM has already put the Pharmaceutical Production Refactoring Tool in practice, in cooperation with an international pharmaceutical company. The model was successfully tested using actual data, and the proposed optimizations were analyzed. This test case revealed that the complex interdependencies of the risk sources generated solutions that were neither obvious nor could have been anticipated intuitively. Not surprisingly, the sequence and timing of optimization measures depended on budget constraints and the source of risk itself. For example, process changes were recommended if a given production technology was on the verge of becoming obsolete and thus its risk potential too great. In certain cases, production was transferred to another site, which altered the risk scenario in which all products manufactured at the new site were exposed. This in turn led to the transfer of certain products to other sites. By transferring risk in this way, a company may be able to greatly reduce its overall risk exposure while increasing profitability.

The IBM Pharmaceutical Production Refactoring Tool can help pharmaceutical companies identify sequences of investments that may improve product quality. However, the tool’s high degree of formalization and innovative and multifaceted approach open the door to other applications. For example, it can be deployed to help select suppliers. Production processes, as well as final products, depend heavily on the quality of raw materials, which can fluctuate significantly from one supplier to the next. This leads to a variety of risk potentials, which the IBM refactoring tool can assess to derive an economically optimized mix of suppliers. The tool can thus help companies in various industries manage their generic risk assessment and process optimization issues.

To find out more about the IBM Pharmaceutical Production Refactoring Tool and other innovative ways to optimize your business, contact IBM Research Services today.