Right First Time via Process Analytical Technology and QbD

The reduction of time to market is a crucial competitive factor for pharmaceutical companies. Key to achieving this reduction is Right First Time, an approach that prevents the production of faulty batches of medicinal products so that they are always within the required specifications.

With our knowledge of Process Analytical Technology (PAT) and Good Manufacturing Practice (GMP) and our SIMATIC SIPAT software, we can help turn quality into an integral part of your production process and enable you to become more flexible at the same time – for production expansions, new products, and entry into new markets.

Right First Time via quality by design (QbD)

The Pharmaceutical CGMPs for the 21st Century initiative of the US Food and Drug Administration (FDA) has led to a rethinking in the pharmaceutical industry. Quality by design (QbD) the transfer of previously downstream quality controls into the manufacturing process itself is meant to accelerate processes and prevent the production of faulty batches of medicinal products.

The introduction of Process Analytical Technology (PAT) supports a Right First Time production process that delivers the correct product quality straightaway.

PAT includes an entire spectrum of systems and solutions that can be used to monitor, analyze, and control the quality of raw materials and process media as well as the performance of the process during production. The quality of the pharmaceutical product can thus be guaranteed with the help of PAT. PAT monitors and documents product quality in real time and allows for a better understanding of the process. The result is a production process that operates according to the Right First Time principle. Another advantage: online monitoring ensures that the process operates within the specifications and thus lowers costs.


Together toward Process Analytical Technology (PAT)

We support the pharmaceutical industry with a comprehensive, multidisciplinary approach during the introduction of PAT. We offer special services and products that meet all requirements. First, we analyze your process to uncover potential for better and more controlled process quality.

Then we develop an optimal strategy with you for the implementation of methods and tools that will allow you to control product quality and get your production processes ready for real-time release.Finally, we provide the technology, expertise, and software that will support you during the step-by-step implementation of your PAT solution.

Throughout, we work according to the principle that a cooperative partnership helps bring new products onto the market faster, improves product consistency and quality, and lowers the risks and costs of production at the same time.

SIMATIC SIPAT for product release in real time

The implementation of Process Analytical Technology (PAT) in the pharmaceutical industry has begun. Siemens has developed the SIMATIC SIPAT software to support this important trend. SIPAT provides a series of tools that support PAT in the development and production processes for example, process analytical tools for process control and the generation of reports. And it is able to interpret and link the data of these tools in an intelligent manner. SIPAT ensures complete data transparency starting with product development and feeds the correlated data back into the process. In addition, it allows reliable forecasts with which the quality and efficiency of the process can continuously improved up to the level of the manufacturing execution system (MES), laboratory information management system (LIMS), and enterprise resource planning (ERP) system. With SIPAT, pharmaceutical manufacturers can achieve a sound understanding of their processes and can release products immediately based upon process data. In short, SIPAT enables companies to develop their processes further based on quality by design (QbD) and Right First Time.

continuous manufacturing pharma industry

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Paperless production

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Continuous production plays an increasingly important role in real-time product release. Based on Process Analytical Technologies (PAT), pharmaceutical companies now have the means at their disposal to design their processes consistently and make them much faster.

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The new SIMATIC IT eBR software solution not only simplifies the implementation of a paperless electronic batch management system, it provides additional benefits by seamlessly integrating the manufacturing execution level into the control system.

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