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.
Generics and Biosimilars: Ensuring Quality from Beginning to End
This whitepaper explores the quality, safety, and efficacy requirements manufacturers of generics and biosimilars must adhere to so that product quality is ensured.
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.
Maintaining Quality in the Delivery of Genetic Medicines
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.
Tackling the Global Problem of Substandard and Falsified Medicines
This whitepaper explores the impact of substandard and falsified medicines and how drug companies and regulators are establishing ways to improve authentication.
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.