• What Can We Learn From Compounding Pharmacies Producing Small Parenteral Batches?

    Does the pharmaceutical industry want to sit on the sidelines while its products are being manipulated and modified — a danger? Or will the industry provide its products in a manner or with the tools that will enable compounding pharmacies to succeed in delivering a safe and effective drug to the patient — an opportunity?

  • Are You Prepared For The Upcoming USP <800> Requirements?

    The United States Pharmacopeial Convention (USP) has developed a chapter on hazardous drug (HD) handling in healthcare, USP <800>, which will become effective on July 1, 2018. For facilities that handle hazardous drugs, there’s no time to waste in working toward compliance, because facility design/redesign and construction may be necessary to achieve it.

  • Yugos & Dueseys: What “Classic” Cars Can Teach Us About Aging Facility Risks

    With an increasing number of pharmaceutical plants having been in service for decades, the topic of aging facilities has become a major concern for regulatory agencies. And rightfully so — aging facilities can contribute to quality issues and drug shortages, among other problems. But what exactly is an aging facility?

  • Single-Use For Fill-Finish: Is It Worth The Risk?

    Single-use technology is a potential solution to some of the problems that have long plagued the fill-finish portion of the pharmaceutical manufacturing process. Aging facilities can contribute to some of those problems, as can capacity issues, where changeover times limit the pace of manufacture.


Christopher J. Smalley

Chris Smalley recently retired from Merck, where he had responsibility for innovative implementation and validation, including single-use systems, globally. Previously, he was director of quality operations for Wyeth Pharmaceuticals for 12 years, with responsibility for setting validation standards and validation activities globally. His research experience includes responsibility for quality in the U.S. operations of the Sanofi Research Division, and earlier he worked for the Johnson & Johnson family of companies, where he was a plant manager. Smalley is a graduate of the Philadelphia College of Pharmacy of the University of the Sciences in Philadelphia. His graduate education includes an MBA from Temple University’s Fox School of Business and an MS in pharmaceutical chemistry from Temple University School of Pharmacy.