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Process Analytical Technology (PAT) – the direct path to the perfect batch
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The FDA has laid the foundation for PAT with its initiative "Pharmaceutical Manufacturing in the 21st Century." The goal of PAT is to optimize production processes in a way that makes quality integral. That requires not just a new approach to production, but also a critical review of all processes that influence product quality, directly or indirectly.
With our PAT approach, we follow the recommendations of the FDA and provide you with support in each individual phase of your PAT implementation with our knowledge of the technological, organizational, and validation-specific aspects of PAT. For example, during process evaluation we search for levers that will allow the systematic improvement of quality control. Based on the information gathered in that step, we develop a strategy for you that will bring you closer to your goals regarding process quality, product quality, and real-time product release. We then work together with you to implement a custom PAT solution based on our proven PAT software SIPAT.
The result is a thoroughly optimized production process that delivers perfect quality, batch after batch, and is always flexible, to allow for expansion of production, new products, and new challenges.
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