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.
Adapting any manufacturing process to continuous manufacturing requires in-depth chemical and mechanical engineering understanding as well as the right technologies.
Artificial intelligence and Big Data have the potential to lower the cost and time of drug trials, to better determine patient outcomes with established drugs, and to better design new drugs.
In 2015, Aprecia Pharmaceuticals produced the first tablet manufactured through 3D printing to be approved by the FDA. Now, with applications in controlled release, short-run medicines, and even the potential for on-site printing at pharmacies, 3D printing technology has the ability to transform the pharmaceutical industry.
The drive to reduce costs, increase speed to market, and meet regulatory requirements has led many pharmaceutical companies to look at single-use, pre-sterilized, plastic equipment systems as an alternative to stainless steel lines. Despite all the benefits — cost, efficiency, etc. — there are still challenges to implementing single-use systems.
Multinational pharmaceutical companies have for decades manufactured drugs for global distribution. Nevertheless, the task of labeling is becoming increasingly difficult and time-consuming.
When looking at facility commissioning and qualification, it's often good to start out with understanding key words so that everybody's on the same page.
With the development of structural, component, or subsystem pieces that are standardized and able to be assembled in virtually limitless ways, pharmaceutical companies can quickly and easily set up their manufacturing facilities.
Pharmaceutical manufacturers cannot limit responsibility for DSCSA compliance to just the engineers and operators involved in processing and packaging.
For the Drug Supply Chain Security Act to be effective, it requires pharma to institute electronic, interoperable systems that enable stakeholders to identify and trace drugs distributed into the U.S.
