The international pharmaceutical supply-chain consortium Rx-360 held a launch meeting in Europe last week with more than 135 industry and regulatory representatives in attendance. Read more »
Technology is not the answer, at least not for tackling pharmaceutical counterfeiting. Instead, increasing criminal sanctions and encouraging relevant parties to work with “certified and reliable partners” are the real solutions. Read more »
Last week, Alexis Pellek of Pharmaceutical Technology wrote about a pilot project launched by the European Federation of Pharmaceutical Industries and Associations to test a new system designed to battle counterfeit drugs (See the blog post.) The system involved using DataMatrix 2D barcodes, which enable pharmacists to test the legitimacy of each packet.
We spoke with Mark Beauchamp, European Marketing Manager of Citizens Systems Europe, a firm that specializes in barcode technology, to better understand how barcoding can help the pharmaceutical industry to clamp down on counterfeit drugs. Read more »
This week, the European Federation of Pharmaceutical Industries and
Associations (EFPIA) launched a two-month pilot project in Sweden designed to test a serialization and verification system in pharmacies that would fight counterfeit drugs. Read more »
IPEC-Americas Chair Janeen Skutnik continued the call for more standards and regulation for the pharmaceutical excipients industry at yesterday’s IPEC Regulatory Conference afternoon session. “We’re not the Rodney Dangerfields of industry anymore,” she said, playing on the fact that many feel excipients are somehow a “lesser” part of the pharma industry because they’re “inactive” drug ingredients. “We need to work with Congress and regulators to put in place the right standards,” she said. Read more »
“We want to be regulated.” That seems to be the theme thus far at the IPEC Regulatory Conference, taking place today and tomorrow in Washington, DC. The morning session opened with IPEC Chair Janeen Skutnik talking about how busy the past year has been for the excipient industry and for IPEC itself. With work being done on pedigrees, functionality, GMPS, and GDPS, excipients are taking on all sorts of new lives. Read more »
Pharmaceutical brands face an increased threat online, according to a new report by the brand-protection firm MarkMonitor. The study, Brandjacking Index: Summer 2009, focused on six leading drug brands and examined these key areas of pharmaceutical brand abuse online: illicit pharmacies, listings on B2B exchange sites, and cybersquatting, or the abuse of a trademark within a domain name. Read more »
The 2009 PDA-FDA Joint Regulatory Conference opened this morning in Washington, DC, with a keynote address by Dr. Joshua Sharfstein, principal deputy commissioner at the US Food and Drug Administration. Read more »
At a joint session of the PharmTech Conference and the 4th Annual Manufacturing Execution System in Life-Sciences Congress earlier this month, during my opening remarks, I discussed FDA’s proposed budget increase of $166 million and 346 FTEs toward Medical Product Supply Chain Safety and Security Oversight. The globalization of manufacturing and supply of medical products has created unique and demanding challenges for industry and FDA alike. Yet, according to a recent Axendia study on QMS trends in Life-Sciences, only 34% of respondents reported view global quality data in real time. Read more »
The high-profile case of contaminated heparin last year was reason not only to consider issues relating to supply-chain integrity, but it also reminded us how critical a production process is to the quality of a drug substance. Pharmaceutical-grade heparin, a sulfated glycosaminoglycan, is derived from the mucosal tissues of slaughtered meat animals such as pig intestines, and a synthetic route has been elusive. Researchers at the Rensselaer Polytechnic Institute (RPI) report on a potentially interesting solution that may not only be valuable for producing heparin, but may also be a relevant approach for developing other biopharmaceuticals. Read more »
From PharmTech.com