Tablets Capsules

TC1020

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18 October 2020 Tablets & Capsules D Deepak Thassu LGM Pharma Using a development and submission stage gate system to help improve drug product development outcomes quality by design The regulatory concept of Quality by Design is a gateway to improved cost control and faster, bigger returns on investment. This article discusses how pharmaceutical manufacturers can unlock these benefits by using a system that integrates their product development and regulatory sciences and submissions teams, focusing on quality at every step. epending on who you ask, the emergence of Quality by Design (QbD) principles in the pharmaceutical reg- ulatory landscape heralds either unwelcome new chal- lenges for drug developers or a golden opportunity to improve quality and drive better business outcomes. Neither opinion is objectively wrong. Traditionally, generics manufacturers could submit an Abbreviated New Drug Approval (ANDA) on the grounds of an off-patent drug's historic success, using publicly avail-

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