A look at PAT technological developments PAT advances lead to greater knowledge for continuous manufacturing

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INTRODUCTION
A high-quality drug is one defined as a product free of contamination and that can reliably deliver the therapeutic benefits promised in its label to the consumer (1). To guide pharmaceutical companies in meeting these requirements when manufacturing medicines and other therapies, the FDA encourages risk-based approaches and the adoption of QbD principles in drug product development, manufacturing, and regulation. The emphasis on QbD from the FDA began with the recognition that increased testing does not necessarily improve quality. This must be built into the product (2). QbD is a pioneering concept first developed by the quality specialist Dr. Joseph M. Juran, who believed that quality should be designed into a product, and that most quality issues relate to the way in which a product is conceived in the first place (3).