By Dave Colombo and Dawn Wang, KPMG Life Sciences Advisory
Last November, after much anticipation, the U.S. pharmaceutical industry saw the enactment of the Drug Quality and Security Act (DQSA), which includes in Title II the Drug Supply Chain Security Act (DSCSA). The DSCSA addresses national pharmaceutical track and trace requirements, and industry stakeholders must now prepare themselves for the first round of deadlines for lot-level traceability starting January 1, 2015. In preparation for these guidelines, it is important for companies to follow a framework as they assess their organizations’ readiness to meet DSCSA compliance. A successful program will do so by evaluating the impacts to their business processes and governance, technical solutions, and trading partner relationships.
By Mike Salinas, et al., M+W Group
Hang around pharmaceutical drug manufacturers long enough and the conversation will undoubtedly turn to both the global dilemma of safeguarding the public from the proliferation of counterfeit drugs and the Drug Quality and Security Act (DQSA).
By Paul Yates, Beckman Coulter Life Sciences
Pharmaceutical cleanrooms have gone through drastic changes in recent years as mergers, acquisitions, facility closures, drug patent-cliffs, and other industry dynamics have forced manufacturing facilities to continually adapt to remain both competitive and compliant with the U.S. Food and Drug Administration (FDA) regulations.
By Christof Kundel, Segment Manager Water Treatment, Bürkert Fluid Control Systems
Reverse osmosis systems play a central part in water treatment. In industrial applications, for example, reverse osmosis is used for purifying process water, producing drinking water, desalinizing seawater, or for producing ultra-pure or pharmaceutical water. In addition to these processes, which are aimed at reducing the concentration of the substances dissolved in the water, the beverage industry also uses reverse osmosis systems for increasing concentrations, e.g., in the manufacture of fruit juice concentrates or for concentrating the must in wine production.
By Alex Verayo, Terra Universal
As cleanrooms grow in size and sophistication, energy demands go up significantly. Even worse, 24/7/365 operation puts substantial particulate loads on filters, increasing maintenance costs and possibly causing unpredictable — and expensive — cleanroom maintenance shutdowns.