Pharmaceutical solid oral dosage product manufacturing is a well-established, yet revolutionizing area. To this end, process analytical technology (PAT) involves interdisciplinary and multivariate (chemical, physical, microbiological and mathematical) methods for material (e.g. materials, intermediates, products) and process (e.g. temperature, pressure, throughput, etc.) analysis. This supports rational process modelling and enhanced control strategies for improved product quality and process efficiency. Therefore, it is often difficult to orient and find the relevant, integrated aspects of the current state-of-the-art. Especially, the link between fundamental Research Article, in terms of sensor and control system development, to the application both in laboratory and manufacturing scale, is difficult to comprehend. This review compiles a non-exhaustive overview on current approaches from the recognized academia and industrial practices of PAT, including screening, selection and final implementations in solid oral dosage manufacturing, through a wide diversity of use cases. Finally, the authors attempt to extract a common consensus towards developing PAT application guidance for different unit operations of drug product manufacturing.

• RCPE GmbH
• Graz University of Technology
• University of Copenhagen / University of Ghent / University of Strathclyde / Rutgers, The State University of New Jersey / University of Eastern Finland / University of Bradford / UCB / AstraZeneca / Bayer / Siemens / Bosch / GEA / Pfizer / DOW.

• PAT
• Oral solid dose

1. Near-infrared spectroscopy
2. oral solid dose
3. pat
4. Process analytical technology
5. Processing
6. Raman spectroscopy
7. Review article
8. Solid dosage form