The implementation of HME/WG would be greatly aided by the better availability of in-line monitoring tools: The technological basis for CM is the use of Process Analytical Technology (PAT), a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of Critical Process Parameters that affect Critical Quality Attributes (CQA).
It has in the past been a real challenge to determine the clinical efficacy of an API online, i.e. during a manufacture process. This made the control and optimization of processes more difficult, as laboratory tests usually take a long time to perform. PAT closes this information gap as data is collected directly in the process in real-time and allows instant corrections and automation. Tools for analysis improve manufacturers’ understanding and control of their processes, increase product quality and reduce the risk of losing products due to nonconformity. Moreover, our approach aligns with the EU strategy to establish a leadership position in “Industry 4.0”, as the novel IMPAX platform will enable data-driven pharmaceutical manufacturing, driving forward Europe´s bid to assume a leading role in tomorrow´s digital economy.
PAT has been defined by the FDA as a mechanism to design, analyse and control pharmaceutical manufacturing processes through the measurement of Critical Process Parameters which affect CQA. The creation of a fully integrated CM process for Pharma will require advanced, reliable PAT. Without such data, the CM proposal cannot achieve its full potential. This is the basis for the IMPAX development of systems specifically tailored to the Pharma industry.
The Executive Agency for Small and Medium- sized Enterprises (EASME) under the power delegated by EUROPEAN COMMISSION (Horizon2020) helps small- and medium-sized enterprises (SMEs) bringing their new products to the market faster. The aim is to promote growth, employment and export, particularly for SMEs, because this group of enterprises will create the major part of future innovations.