The past few decades have brought radical change to the pharmaceutical and healthcare industries. Generic pharmaceuticals now account for 90% of prescriptions in the United States, and manufacturers in the US and Europe continue to outsource more of their strategic operations to service providers. As a result, global pharmaceutical supply chains, even for widely used treatments, have become increasingly complex. Managing these supply chains is challenging but crucial, particularly in light of ongoing drug shortages. Maintaining product consistency and manufacturing relies on identifying multiple suppliers that can make active ingredients and excipients to required standards.
Manufacturers must set a specification that defines those standards as a critical first step to ensuring and managing product quality. However, it is not unusual for an established specification to fail to capture an aspect of behavior that results in poor performance during manufacturing. This article examines how powder testing can be integrated with manufacturing and quality operations and used to optimize raw material selection and process optimization, sharing results of some inhouse projects at GlaxoSmithKline (GSK).
Please click here to read ‘Integrating Powder Characterization into Raw Material Selection and Process Optimization’ in the latest edition of Pharmaceutical Technology.