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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’…

FMD and supply chain security

18 April 2017 | By

Over 12 months ago, the European Union delegated regulation that supplements the Falsified Medicines Directive (FMD) was published in the Official Journal of the European Union, starting the countdown to the deadline of 9 February 2019, when most EU member-states, and three non-members currently, are expected to have implemented all…