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.
This whitepaper explores the quality, safety, and efficacy requirements manufacturers of generics and biosimilars must adhere to so that product quality is ensured.
Discover how Quality by Design (QbD) principles help ensure that pharmaceutical products consistently meet predefined characteristics and any variability is identified and explained.
Dr. Mansoor Amiji, Northeastern University, US, discusses the quality requirements for genetic medicines and how regulatory agencies are working to keep pace with these complex products.
This whitepaper explores the impact of substandard and falsified medicines and how drug companies and regulators are establishing ways to improve authentication.
An overview of the guidelines that govern medicine quality and the various challenges that the regulatory agencies face to drive pharmaceutical quality excellence.