Pharmaceutical Technology - October 2021


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22 Pharmaceutical Technology APIs, EXCIPIENTS, AND MANUFACTURING eBOOK 2021 P h a r mTe c h . c o m Excipients T he COV I D -19 pa ndem ic ha s d raw n at tent ion 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 (1). This complex supply network has f lexed rapidly and successfully to answer to the demands of the pandemic, with manufacturing plants switched to the produc- tion of hand sanitizer, manufacture of materials in short supply due to regional outbreaks, or, for the longer term, making respi- ratory drugs and vaccines. However, changes in supply chain or plant use are challenging for this heavily regulated industr y, particularly given the criticality of product quality and safety. Reliable specifications, for products and raw materials, pro- vide a secure foundation for those navigating the global phar- maceutical supply network and are increasingly important as the industry regroups, drawing on lessons learned. Powders are par- ticularly challenging in this regard, with conventional specifica- tions often failing to successfully differentiate materials. This article explores reasons why specifications for products and raw materials fail, and experimental data illustrating how powder test- ing can be used to establish better, more robust specifications will be provided. Building Robust Specifications Using Powder Testing Jamie Clayton Advanced powder testing is a useful tool to differentiate materials and optimize the supply chain. Jamie Clayton, jamie., is operations director, Freeman Technology (a Micromeritics company), Gloucestershire, UK. PAYLESSIMAGES - STOCK.ADOBE.COM

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