Joseph Zeleznik is manager, technical & regulatory affairs at Meggle USA.
Mitigating the Risk from Excipient Variability
This article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.
The Real Complexity of Excipient Composition
This article seeks to promote dialogue among stakeholders to facilitate consensus regarding requirements for excipients.