IMA Active and CONTINUUS Pharmaceuticals examine continuous manufacturing of solid oral dosage forms by integration of Raman spectroscopy to an Extrusion-Molding-Coating (EMC) unit.
Tablets
Process Analytical Technologies (PATs) are intended to support innovation and efficiency in pharmaceutical development, manufacturing, and quality assurance. The framework is founded on process understanding to facilitate innovation and risk-based regulatory decisions by both industry and regulatory agencies. Lately, regulatory agencies have been encouraging manufacturers to use a framework of PATs to develop and implement effective and efficient innovative approaches for pharmaceutical manufacturing. The purpose of using PATs is to design and develop dynamic manufacturing processes that can compensate for variability in both raw materials and equipment to consistently ensure a predefined quality at the end of the process. The objective of the PAT application is to monitor and control the product quality in real-time. Thus, downstream and upstream operations can be adjusted accordingly without delay. PATs aim to ensure that critical sources of variability affecting a process are identified, explained and managed. Therefore, a real-time release testing (RTRT) strategy should be based on a firm understanding of the process and of the relationship between process parameters, in-process material attributes and product attributes. Then, closed-loop control allows fine-tuning of process parameters based upon thorough knowledge of how the components and related processes affect the final product. The PAT ideology is in accordance with the fundamental principle that quality should not be tested, but rather be built into the product by design. The association of PATs, sensors and an integrated control system enable the design and development of dynamic manufacturing processes. Indeed, all variabilities affecting the process might be identified, explained and managed, to ensure a high and consistent product quality overtime by automated and real-time measurements 1–3.
Process context