![]() ![]() CM process development is knowledge-intensive, and the first component of CM implementation is an accurate in-line, real-time process monitoring (RTPM) tool. This innovative approach involves the seamless integration of multiple unit operations into a continuous process, leading to more efficient, cost-effective, and scalable production. ![]() Real-time process monitoring of these critical quality attributes is also a challenge for quality control.Ĭontinuous manufacturing (CM) of oral solids is one of the most important emerging technologies in the sector. It is critical to have a robust manufacturing process that can repeatedly deliver high-quality products that meet all critical quality attributes of the formulation. ![]() The manufacturing of pharmaceutical oral solids products, such as tablets, requires precise control over the active pharmaceutical ingredient (API) concentration to ensure product efficacy and safety. Product quality is the most crucial aspect of pharmaceutical manufacturing. It has published guidance on Process Analytical Technology (PAT) implementation in the mid-2000s and continuous manufacturing in 2022. The Food and Drug Administration (FDA) has realized the benefits of implementing new initiatives in pharmaceutical product development and manufacturing. The pharmaceutical manufacturing industry has seen significant growth and advancements in recent years, driven by a combination of factors, including increased adoption of new technology, advances in computing and information technology, and growing demand for innovative medicines. ![]()
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