Key Elements For Success: Implementing PAT In An Oral Solid Dosage Plant

PAT (Process Analytical Technology) and QbD (Quality by Design) are the current buzzwords in the pharmaceutical industries, claiming to reduce waste, increase R&Q (reliability & quality) and Production yields and finally to reduce costs. But introducing and implementing PAT, for instance into an Oral Solid Dose (or OSD) plant, is a complex matter, and requires integration of different sources of data and different business layers. This article tries to give an insight into this complexity, describing the different kinds of data, each with their specific properties. Focus is also set on the actual integration and the alignment of all these data sources, enabling a common PAT data platform that is the source to create process understanding.

Further an explanation is given of how a PAT infrastructure can be embedded in the company’s ICT and automation infrastructure. PAT should be a lean system that does not impact your operator’s and researcher’s daily business. Finally the challenge of a global approach is addressed: How can securely built up knowledge and stringent validation effort are leveraged within a global company’s infrastructure?