By Lisa Cherry, Ph.D.
Whether you work with a CDMO or manufacture your drug at one of your own sites, there will likely be changes in raw materials from time to time. These include modifications in API synthesis, key starter materials, and intermediates. That’s to be expected throughout the lifecycle of a drug. A “best practices” approach to accepting alternate material from a supplier is vital to maintaining drug integrity.
Changes in raw materials may occur for a variety of reasons, such as the adoption of advances in manufacturing processes, availability of “equivalent” less expensive raw materials, or a change in the manufacturing location of a raw material producer. Astute raw-material control personnel manage these changes carefully. They know a seemingly minor change may have a significant impact on the behavior of the raw material in a drug production environment.
The following case studies illustrate a robust materials review process and material control system to assure continuous drug manufacturability, quality, and usability, even when alternate material behaves somewhat differently than the original. Although these case studies pertain to sterile injectables, the principles described and trouble-shooting required apply to small-molecule drugs in general.