Quality of Medicines Series
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White Paper

Quality of Medicines Series

Introduction

Poor-quality medicines are those that do not meet acceptable standards for strength, quality, purity, packaging, or labelling and their distribution can pose significant risks to patient health. Ensuring medicine quality along every step of the development journey is therefore critical; but it requires a concerted effort by all those involved in the manufacture and distribution of medicinal products.

This series of whitepapers explores the general guidance’s relating to the quality of medicines and challenges posed by substandard and falsified products. It also explores how the regulatory agencies are having to keep pace with the fast-moving developments in the field, such as cell and gene therapies and complex biologics.

Quality by Design, Every Step of the Way

Quality by Design, Every Step of the Way

Discover how Quality by Design (QbD) principles help ensure that pharmaceutical products consistently meet predefined characteristics and any variability is identified and explained.

Drive Pharmaceutical Quality Excellence

Drive Pharmaceutical Quality Excellence

An overview of the guidelines that govern medicine quality and the various challenges that the regulatory agencies face to drive pharmaceutical quality excellence.