ARTICLES BY CHRISTOPHER J. SMALLEY

• 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.