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.