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Quality by Design (QbD)

 

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What do we need from PAT?

18 December 2017 | By ,

Pharmaceutical manufacturing in the modern era is facing unprecedented demands, including in-depth scrutiny of production methodology, and inefficiencies in current practices with respect to waste, energy usage and time management. Coupling this with increased complexity in the manufacture of newer products and the decline of blockbuster drugs, results in an…

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Pharmaceutical QbD: Omnipresence in the product development lifecycle

18 April 2017 | By , ,

The concept of Quality by Design (QbD) was implemented by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and United States Food and Drug Administration (FDA) around a decade ago, with the aim of adopting systematic approaches for developing high-quality pharmaceutical products for patients’…