Spring Intro 2023

03/03/2023

Introduction

• Quality/Safety/Efficacy-3 legs of the licensing process • Quality is an inherent

objective in itself as well as a determinant of safety and efficacy considered as a continuum from development through marketing and beyond 2001/83/EC as amended requires a commitment to continuous improvement (manufacturing and analytical procedures).

• Quality should be

efficacy

safety

• Article 23 of Directive

03/03/2023

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Introduction

• Quality cannot be “tested in” to a product • Quality assurance embraces product design

• Total quality strategy involves • Product development

• Manufacturing process optimisation • GMP conformance • Compliance with specifications/pharmacopoeias • Stability testing • Good distribution, transport, storage and dispensing practices

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