Building Robust Specifications Using Powder Testing

The COVID-19 pandemic has drawn attention to pharmaceutical supply chains, notably increasing public awareness of how and where drugs and vaccines are made. While the United States and European Union (EU) retain the two top spots in terms of number of FDA-registered manufacturing plants, China and India, together, now account for 31% of these facilities. India alone supplies 40% of the world’s generic drugs but relies on China for 70% of the raw materials and APIs used to make them. This complex supply network has flexed rapidly and successfully to answer to the demands of the pandemic, with manufacturing plants switched to the production of hand sanitizer, manufacture of materials in short supply due to regional outbreaks, or, for the longer term, making respiratory drugs and vaccines. However, changes in supply chain or plant use are challenging for this heavily regulated industry, particularly given the criticality of product quality and safety.

Reliable specifications, for products and raw materials, provide a secure foundation for those navigating the global pharmaceutical supply network and are increasingly important as the industry regroups, drawing on lessons learned. Powders are particularly challenging in this regard, with conventional specifications often failing to successfully differentiate materials. This article explores reasons why specifications for products and raw materials fail, and experimental data illustrating how powder testing can be used to establish better, more robust specifications will be provided.

Read this article in Pharmaceutical Technology’s October 2021 APIs, Excipients, and Manufacturing eBook.

About the Author

Jamie Clayton, jamie.clayton@freemantech.co.uk, is operations director, Freeman Technology (a Micromeritics company), Gloucestershire, UK.

Article Details

Pharmaceutical Technology
eBook: APIs, Excipients, and Manufacturing
October 2021
Pages: 22–29

Citation

When referring to this article, please cite it as J. Clayton, “Building Robust Specifications Using Powder Testing,” Pharmaceutical Technology’s APIs, Excipients, and Manufacturing eBook (October 2021).