Compliance Matters

Cover: Thomas Cosgrove, director of FDA’s Office of Manufacturing Quality discusses his work to protect patients from the risks posed by poor drug quality. Data integrity, he says, is a big part of the solution.

Getting It Right

Joe Famulare, ISPE Board Chair, weighs in on compliance, quality metrics, and how new technology is changing the industry. He also sat down with a panel of medical experts as part of an national radio broadcast to discuss drug shortages.

Biopharma Dominates Smartest Companies List

Thirteen life sciences companies were among MIT Technology Review’s “50 Smartest Companies for 2015,” a much more impressive showing than in previous years, mostly for pioneering technologies that can tackle challenging illnesses.

Data Integrity

SPECIAL REPORT: Our six-part special report explores this multifaceted subject, describing the desired state, identifying red flags, and enumerating best practices. Our experts define the strategies that drive prevention, detection, and response: administrative and technical controls, effective review processes, critical success factors, and corporate training to encourage integrity.

Enhancement of Solubility and Stability of Itraconazole by Formation of Solid Crystal Suspensions Using Hot Melt Extrusion

Jaywant Pawar, Vinod S. Gokarna, Vineeta D. Deshpande, and Purnima D. Amin

The History of Cleanroom Garments

Jan Eudy

Association of QbD Tools with Biopharmaceutical Classification Systems

Mehtap Saydam

Quality Risk Management for Legacy Products in CMOs

Humberto Vega and Ricardo Rivera

In This Issue