Pharmaceutical companies today are faced with challenges such as global competition, reduced patent protection, the rising cost of drug development, and FDA initiatives. The convergence of these factors has caused increased strain on corporate resources and has raised the very important question: how can pharmaceutical companies possibly get a return on their billion-dollar research and development (R&D) investments?
THE COMPLEX TASK OF MANAGEMENT Inevitably, when something goes wrong for facilities managers, the issue typically involves the company's asset management operations. If a piece of equipment breaks down, is not where it is supposed to be, or, worse yet, is not in compliance with federal regulations, the problem is usually a function of faulty asset management.
Effectively managing capital assets has long been a difficult task for facilities managers in the pharmaceutical industry. Managers of manufacturing facilities may be responsible for thousands of assets, and optimizing the deployment and operation of all these assets requires meticulous attention to detail. Facilities managers in the pharmaceutical industry in particular must meet the requirements set forth by regulatory agencies or face severe consequences — including fines, plant closings, and lost revenue.In 1997 FDA introduced the regulations contained in Title 21 of the Code of Federal Regulations Part 11 (21 CFR Part 11).1 These regulations, which pertain to electronic records and electronic signatures, have been a driving force behind streamlining facilities management processes. While some view Part 11 as a regulatory hindrance, it was in fact designed to establish a set of guidelines for improving security and efficiency within the drug development and manufacturing processes. Employing electronic signatures and electronic records as specified by Part 11 yields numerous benefits, including improved efficiency, faster time to market, better quality, and risk avoidance.
In a pharmaceutical manufacturing plant, the failure to meet regulatory requirements can be devastating. The most severe penalties for regulation infractions result in a plant shutdown, which can have serious implications for production and revenue. There are many ways a company can become compliant, but it is important that the costs of compliance — in terms of money, labor, and interruptions to workflow — are kept to a minimum.
With increasing competition and the demands of Part 11 compliance, companies must streamline business processes and cut costs in order to stay ahead. Asset performance management, which may not previously have been part of a company's strategic planning, is now viewed as a critical component in speeding the flow of new drugs into the marketplace.
SEARCHING FOR A SOLUTION From the standpoint of manufacturing's best practices, pharmaceutical companies reap greatest benefits from regulation-related solutions that have minimal impact on production throughput. Solutions that allow for compliance and ease of use are the most effective choices for companies looking to pass inspection without sacrificing productivity.
Traditional asset management consists of add-on maintenance modules, but these can be difficult for operators to use. At the same time, the task of bringing older computerized maintenance management system (CMMS) programs and home-grown calibration systems into Part 11 compliance can be prohibitively expensive and time-consuming. Faced with these challenges and needing to satisfy changing production requirements, a pharmaceutical company may even consider buying new plants or installing new equipment. An alternative approach, however, involves rethinking and re-evaluating existing equipment and asset management.
Evaluating equipment performance and processes warrants certain considerations, such as:
Web-based asset performance management provides pharmaceutical manufacturing with a number of advantages over traditional asset maintenance and tracking. With traditional paper-based processes, it is difficult to demonstrate that data are securely and accurately captured, because paper records are cumbersome and data on paper is difficult to store, retrieve, and access. Moreover, the use of paper records can cause regulatory compliance issues when a company is unable to locate and deliver required product and process records and associated information.