Irwin Silverstein, PhD

Defining quality for excipients may not be as clear cut as it is for APIs, but it is essential to product quality and patient safety, and to choosing the best supplier.

The author discusses key areas of focus and presents best practices from the International Pharmaceutical Excipients Council (IPEC).

Choosing the right excipient manufacturer can help ensure the use of quality excipients.

This article demonstrates that test results support the position of FDA on the importance of an appropriate supplier-qualification program.

The less complex nature of excipient manufacturers, as compared with API manufactures, carries many benefits.

A new set of proposed GMP standards for excipents may present more problems than benefits.