As such, guidelines by the European Medicines Agency (EMA) and FDA have been elaborated, dealing with the development and data requirements for submitting Near Infrared Spectroscopy (NIR) procedures in 20, respectively. Īs demands for the application of advanced technologies have increased, regulatory documents aimed to formulate specific frameworks regarding the analytical development and validation methodologies to facilitate the application of chemometrics in pharma. In this respect, the European Directorate for the Quality of Medicines and Healthcare issued the “Chemometric methods applied to analytical data” monograph in 2016 to encourage using these analysis methods as an integral part of PAT applications. Frequently, these high throughput instruments produce large datasets recorded over multiple variables, requiring specialized data analysis methods. The major challenges associated with the adoption of PAT in the pharmaceutical industry refer to the integration of the probe, the sampling interface, data collection, modeling, linking to a control system, the calibration of the method, and finally, the validation of the integral system. Thus, the reliability of a PAT procedure for the manufacturing requirements and the selected control strategy is conditioned by its design, performance qualification, and ongoing performance verification within proper lifecycle management. Both options could be very efficient if sufficient data is used to design these process control tools to support their use. Process monitoring can be performed with various instruments, from built-in univariate sensors to more complex sensors that can be interfaced with the process stream. This ability to monitor a process in real-time and obtain an improved understanding of product-process interplay requires appropriate tools (PAT instruments) that can track the right product attributes. The increased amount of data obtained from monitoring can further guide the optimization and continuous improvement of the system, generating additional monetary value. The immediate financial benefit/impact of a PAT-based control strategy translates into an increase in production yield and a reduction in manufacturing costs. The driving force of many pharmaceutical companies to introduce PAT in their manufacturing environment is referring to the reduced batch failures and reprocessing, production process optimization, and faster release testing with the opportunity to enable real-time release testing through feedback and feedforward control loops. Concurrently to these, the appearance of the Food and Drug Administration’s (FDA) guidance on Process Analytical Technology (PAT) in 2004 forecasted an important paradigm shift of the major regulatory bodies according to which quality cannot be tested in products it should be built-in or should be by design. The adoption of the ICH Q8-10 guidelines and the elaboration of the concept of design of experiments by pioneering researchers in this field represented notable milestones in the quality management of pharmaceutical products. The pharmaceutical industry has witnessed substantial changes from a regulatory perspective in the past few decades, aiming to ensure the quality of the pharmaceutical product by a thorough understanding of both the product particularities and the manufacturing thereof. Furthermore, the integration into Pharma 4.0 is discussed. Special attention is given to the data types available from pharmaceutical manufacturing and their compatibility with data fusion strategies. This survey evaluates the challenges and opportunities of implementing data fusion within the PAT concept by identifying transfer opportunities from other sectors. To this respect, data fusion strategies have been extensively applied in different sectors, such as food or chemical, to provide a more robust performance of the analytical platforms. However, their transfer to the highly regulated pharmaceutical sector has been limited. The technical opportunities to reach this high-level control have considerably evolved since 2004 due to the development of advanced analytical sensors and chemometric tools. 42 wishlist games found in available bundles.The release of the FDA’s guidance on Process Analytical Technology has motivated and supported the pharmaceutical industry to deliver consistent quality medicine by acquiring a deeper understanding of the product performance and process interplay.
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