FDA’s First Draft Guidance Under DSCSA – What It Tells Us And What It Doesn’t
On June 10th, the long-awaited first draft guidance under the DSCSA was released by the FDA. For those holding high expectations that the guidance would offer specific direction on how to handle suspect/illegitimate products internally, you may come away feeling a little shortchanged. However, in the past, the FDA has come under scrutiny for using guidance to replace rule making, since this requires legislative involvement, so the lack of detail in the draft may be an effort to make room for flexibility that industry felt they weren’t getting before. Whatever the intent, the draft guidance does provide some learning opportunities and also a very subtle call to action. I recently spoke with David Colombo and Dawn Wang with KPMG Life Sciences Advisory to find out what can be learned from this draft and where we go from here.
WHITE PAPERS & CASE STUDIES
Drug Safety And Product Protection Driving Blister Packaging Growth
Trends in packaging of prescription and over-the-counter drugs indicate continued growth in the blister packaging market. The U.S. blister market size reached $2.58 billion in 2013 and is projected to reach $3.44 billion by 2018. This escalation outpaces the growth of other packaging formats, principally bottling. While key factors driving that trend reflect the ongoing focus by manufacturers on drug safety and protection, others arise from the latest government regulations and the growing voice of the consumer.
Design And Installation Considerations For VHP-Resistant Remote Particle Counters
VHP sporicidal-gassing decontamination utilizes a free radical reaction to kill microorganisms on surfaces. Damage as a result of exposure can cause false particle counts, calibration errors or a complete particle counter malfunction.
Procedural Reliability In Pharmaceutical Production
The worst thing that can happen on a pharmaceutical production line is a mix-up, i.e. either the product or the ID code is not what it should be.
Vision System Increases OEE By 200% On Pharmaceutical Packaging Line
A major pharmaceutical manufacturer’s packaging line presents a challenging vision system application because of the need to select exactly the right label among dozens of possible alternatives needed to meet differing languages and regulatory requirements around the world.
High-Speed Pharmaceutical Glass Vial Inspection With In-Sight Vision Systems
Few industrial sectors have such stringent quality requirements as the pharmaceutical industry. To meet these exacting specifications, companies are increasingly utilizing intelligent vision systems.
Pharmaceutical Product Traceability Achieved With 2-D Barcode Reading
Within the pharmaceutical industry, stringent legislation exists to combat counterfeit goods by ensuring each product can be traced throughout the supply chain. In order to achieve the required levels of traceability, manufacturers are increasingly reliant on printed 2-D codes combined with advanced code reading technology.