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The maxim “Time is money” is particularly appropriate for the current situation in the pharmaceutical industry. The companies here are therefore striving to keep the time to market launch of a product as short as possible. An efficient information management system helps them in this and optimizes the design and operation of a plant. Consequently, they achieve considerable competitive advantages.
The highly regulated environment of the pharmaceutical industry represents great challenges for companies in this sector. When designing and operating a plant or production processes, necessary compliance with national and international instances, such as the Food and Drug Administration (FDA) or the European Medicines Agency (EMA) must be observed. Recommendations from independent institutions, such as the Society for Pharmaceutical Engineering (ISPE) are also very important for the design and legally compliant operation of pharmaceutical plants.
Plant Complexity and Data Volumes Are Increasing
Apart from the various regulations, short patent terms and increasing costs in drug development and in production result in enormous cost pressure for companies. Drug manufacturers are reacting to this development with modern, highly productive, but also very complex, industrial plants. There is an increasing flood of data in the production plant because of the regulations. In the meantime, it is not unusual to find data volumes in the terabyte range requiring management in pharmaceutical plants. To cope with this task, companies are using high performance software tools. These software solutions, such as Comos from Siemens, facilitate effective, uniform plant management and comply with the internationally accepted Good Manufacturing Practice (GMP) guidelines.
These data and information management systems should even be used in the early development process for drugs. As integration of development information from the clinical test phases into the scale-up activities and into the design process and operation of a plant improves the quality of the plant management and futhermore leads to faster availability of the products and to lower costs. The software facilitates the re-use of plans for plant areas already designed and realized.
How to Be In the Know of Planning
Additionally, standardization within plant design, such as through created templates and predefined modules, becomes possible. Both lead to a reduction in engineering times. If all participants have the information in a transparent and consistent form, qualification of the plant and verification of the product quality can take place as integral components of the plant design. In subsequent plant operation, all the relevant information is available “in the right place at the right time”.
The reorientation of the regulatory authorities to continuous process verification requires new, function oriented methods such as the Risk-based Approach (RbA), which can be reproduced with the software solution Comos. This increased focus — referred to by experts as a “paradigm shift” — on the end products security can be supported simply with the software.