By Ron Guido, VP of Global Brand Protection and Supply Chain Integrity, Johnson & Johnson
This fictional account details the risks of counterfeit medicines entering the legitimate supply chains and genuine medicines diverted into the gray market.
By Reynaldo Roman for Marken
On December 21, 2012, the U.S. Fish and Wildlife Service (FWS) finally addressed an issue that has been of significant debate among importers of Chinese Hamster Ovary (CHO) cell specimens and trade experts. FWS informed the trade community that only shipments of actual CHO "cell," "cell cultures," and "cell lines" are regulated by the agency and require an import/export license for trade.
By Jeff Clark, 7P Solutions™, LLC
Quality is certainly not new terminology in the pharmaceutical industry. However, I believe it is a term that is sometimes used too loosely within the pharmaceutical time and temperature supply chain.
By Christine Park, Quality Architech
Personnel resources. We all have them and we all need them. The real question is do you have the right resources? And, do you have enough to support your quality system? 21 CFR 211.25 specifies requirements for personnel qualifications. This includes individuals working in the manufacturing operations, quality personnel as well as supervisors and managers. The regulation speaks to education and job specific training, as well as the number of personnel to perform tasks and duties.
By Bryan Downer, Solutions Expert at CSI
The science of process cleaning is changing. Considerations for process cleaning and CIP now include much more than they did just a few years ago. Energy efficiency, water usage, waste reduction, and solids recovery have all begun to affect the design of process cleaning systems.
By Max Blomberg and Christian Julien, Meissner Filtration Products
The benefits of utilizing single-use systems (SUS) within the biopharmaceutical industry are well documented in the popular press and heralded at many conferences. At a fundamental level, they present exciting and often unprecedented opportunities in terms of increased productivity, the ability to make rapid capacity adjustments, and lower the overall costs of manufacturing. However, what an end user is effectively outsourcing when they choose to include single-use assemblies within a given process step, or as the scope of their implementation broadens to include an entire process, must be considered.
By Christine Banaszek, Application Engineer
Laboratory testing is an integral part of equipment procurement. In the case of mixing and blender equipment, two or more fundamentally different devices may present to be viable solutions to a particular process, and the only way of determining the best technology is by performing lab tests. This hands-on approach works best when the main variables — raw materials, temperature, pressure, batch size, etc. — are simulated as close as possible to the actual process.
By Kevin Zarnick, Pharmaceutical Sales Manager, Product Inspection, Thermo Fisher Scientific
Using metal detection as a means of identifying foreign object contamination has been prevalent in the food industry for decades. Although metal detection has also been in use to identify the presence of ferrous, nonferrous, or stainless steel contaminants during the past 40 years in the pharmaceutical industry, it has not been widespread.
INTERPHEX is the leading annual pharmaceutical and biopharmaceutical trade show, taking place in New York City on April 23 to 25, 2013. Key decision makers will find the networking opportunities, products, services, and information they need to ensure quality and to maximize the efficiency, agility, and flexibility that solve manufacturing and supply chain problems. INTERPHEX is where intelligence and passion intersect with the full spectrum of industry products and services to create new insights and innovation. Learn more