Featured Pharma Online Editorial
-
COVID-19, Medical Drones, & The Last Mile Of The Pharma Supply Chain
4/6/2020
During crises like this pandemic, bottlenecks in drug distribution and sample testing can be improved through automation, artificial intelligence, and robotics. This article provides an overview of the medical drone industry, with a particular emphasis on its adoption by the pharmaceutical sector to solve logistical problems in healthcare during times of heightened need.
-
COVID-19: 5 Steps To Achieve Situational Awareness In The Pharma Supply Chain
3/26/2020
To address the current worldwide COVID-19 pandemic, more controls are being imposed by cities, states, and countries. Trucks are being delayed at borders. Flights are being canceled. It is important to be capable of adapting work practices around this ever-changing situation.
-
Are You Ready For A DSCSA Audit? 5 Steps To Ensure The Answer Is “Yes”
3/16/2020
During an FDA audit, you're asked questions about the U.S. Drug Supply Chain Security Act and how you offer and share your T3 data with downstream trading partners. Do you answer confidently, or hold your breath and gulp?
-
The 5 Pillars Of Clinical Trial Material Management
2/25/2020
Ensuring that enough study drug supplies are available at study sites is a requirement of every clinical trial. This article discusses five fundamental tools and techniques for effective planning, execution, monitoring, and inventory control of clinical trial material from the manufacturing, packaging, and distribution perspectives.
-
The Need For Digital Networks To Support Cell And Gene Therapies
12/30/2019
Cell and gene therapies have a level of complexity from a supply chain perspective that needs new approaches, including a high level of information sharing and integration. This topic was covered from different perspectives at two recent conferences.
-
5 Barriers To Blockchain Adoption In The Rx Supply Chain — And How To Overcome Them
9/11/2019
Blockchain has already started to find fit-for-purpose use cases in the pharmaceutical industry. Some of the largest pharma companies in the world are now conducting pilots and are expected to move towards production cases in the coming year. But for blockchain to succeed, several remaining obstacles must still be overcome.
-
Pharmaceutical Transport Validation — Where To Begin?
9/6/2019
This article provides a road map for transport validation, which is used to qualify packaging for the entire product supply chain. When transport validation is done incompletely, poorly, or not at all, it can result in off-label drugs that are potentially harmful to patients.
-
Aggregation 101: Connecting The Dots Between Pharma Serialization And Track-And-Trace
8/19/2019
From “serialization” to “coding” to “track-and-trace,” the pharmaceutical industry is rampant with terms that point to the quest for transparency. The latest of these is “aggregation,” a burgeoning method of data collection aimed at simplifying inventory and the supply chain. While still in its infancy, the technique can help to combat counterfeiting, theft, inefficiencies, and confusion as a whole. Yet, with every new process comes challenges, requiring manufacturers considering aggregation to seek best practices for implementation.
-
FDA's First DSCSA Warning Letter — A Closer Look
3/11/2019
The FDA issued the first warning letter related to the DSCSA amendments to the FD&C Act. This article takes a look at this warning letter and explains why pharma manufacturers should care.
-
FDA's DSCSA Pilot Project Program — Should You Participate?
3/4/2019
The FDA announced its intent to establish a pilot program to “share information, current practices, research, and ideas on the feasibility of establishing standardized documentation to be used by members of the pharmaceutical distribution supply chain to convey the transaction information, transaction history, and transaction statement to the subsequent purchaser of a product and to facilitate the exchange of lot level data.” The question for the industry is, should you participate in the pilot program?