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.
Efficient Plant Management Required
The far-reaching and globally realizable software solution Comos guarantees efficient plant management in the process industry. It provides data transparency as well as interoperability, which are essential in the design and operating phase of pharmaceutical plants.
In this context the consistent alignment toward the object-oriented architecture of Comos must be mentioned here.
The object-orientation is an important basis for inputting information, which is required several times, only once and for providing it to all the necessary areas across the entire life cycle of the plant at all times. As a result, information losses and errors resulting from multiple inputting or incorrect data transfers are avoided.
Plant Planning From Early Stages On
The design data can be used even at an early stage of the plant planning to create process flowcharts, which are then detailed in the pipe and instrumentation flowchart. The quality assured pipe planning and pipe specification classification takes place on the basis of international industrial standards. The geometric realization of process data in the form of isometrics and 3D representations can be derived simply from the information in the database.
All electrical, metering, steering and control-relevant planning processes are covered by the software. For example, logical links between the objects and the automated processes are graphically represented in charts and hydraulic and pneumatic sequence diagrams are created on the basis of the current information. All the information from the planning phase can also be used in the subsequent operating phase. Consequently, the software also offers various solutions for plant maintenance.
Plant Management Software Specifically For the Pharmaceutical Industry
The standard software solution Comos has been expanded in close cooperation with renowned companies in the pharmaceutical sector: the result is a solution, which tangibly address the requirements of this industry.
For example, the necessary document structure is created automatically in the design and engineering phase. Complemented by a clear allocation of responsibilities and schedules, the requirement for successful project controlling is created. The documents are processed promptly by the responsible persons and forwarded to the respective appropriate authorities. This procedure is already the first step toward compliance (see above) and can be supplemented with high-level risk monitoring to identify quality-critical systems.
The software’s uniform information platform guarantees the implementation of more efficient work processes compared to the previously usual processes. A function-oriented holistic consideration of all trades and technical disciplines is necessary for this. The open system architecture also ensures seamless cooperation with other software solutions, such as control and ERP systems. This creates the conditions for the qualification of the entire plant (or all the plants) beyond all engineering and operating phases.
Whether the plans and the actual plan correspond, alongside the specifications regarding materials and suppliers, can be easily checked using the software. All test results of the function qualification are uniformly documented and archived throughout. They can also be easily accessed.
All required documents are available at all times in their current form and reflect the qualified current status of the plant. All the steps to release are completed efficiently, from the first drawing to daily operation.
Changes Are Digitally Documented Straight Away
Any changes to the current status of the plant are integrated in the software solution and are agreed with the “digital plant” there. This prevents discrepancies between the digital and physical plant. Smaller projects and changes to an existing project can be realized quickly thanks to the modular design of the software. The need for renewed qualification resulting from changes to the plant can be simply assessed.
If re-qualification is necessary, corresponding steps can be quickly taken. Existing documents from previous projects can also be stored in the software. These can then be easily transferred into a new project. This allows the knowledge and experience from previous project phases to be exploited. The duties to inform the relevant authorities can also be fulfilled without a problem. Integrated information management is the key to the optimal planning and efficient management of pharmaceutical plants.
Plant Management: A Connection of Planning and Operation
Comos supports all the processes required for this and simplifies your planning and documentation with its unique, integrated data basis and modular structure. This shortens the planning time, allowing faster market launch, which means that patent terms for the drug are optimally exploited. Additionally, the costs for any changes in the deployment stage and in the operation of the plant are reduced considerably.
With its holistic and information data basis, plant management with Comos supports all the processes required for integrated information management and simplifies the design, operation and documentation of pharmaceutical plants. Cooperation between plant operators and engineering, procurement and construction (EPC) providers is make easier with this software, allowing the planning and operating worlds to connect better. This in turn leads to a faster market launch of new drugs and to the minimization of risks and costs. The companies in the pharmaceutical industry therefore enhance their overall competitive situation significantly.
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