In 2008, adverse affects and deaths linked to Baxter’s blood thinner drug heparin revealed contamination in the heparin supply chain originating from an API manufacturer in China. FDA identified oversulfated chondroitin sulfate (OSCS) in the contaminated heparin. In response to the 2008 heparin situation, the United States Pharmacopeia Convention (USP) has revised the quality standards for heparin. Anita Szajek, PhD, and Tina Morris of USP highlight USP’s revisions to the heparin sodium monograph in the September 2012 issue of PharmTech.
Archive for the 'supply chain' Category
Cargo theft, for many years, was a problem that largely plagued the electronics industry, but criminals have recently shifted more attention to the far more lucrative pharmaceutical trade. In March 2010, thieves masterminded a heist of $75 million worth of cancer, psychiatric and blood-thinning drugs from a Connecticut warehouse by cutting a hole in the ceiling and dismantling alarms during a severe storm that masked their activities from the local authorities. To curb future cargo theft, it is imperative that pharmaceutical companies develop solid, globally applicable conveyance security programs.
Read about theft-preventing strategies in the August issue of PharmTech
What will be the future of pharmaceutical outsourcing? What factors will influence the relationships between sponsor companies and contract service providers and what practical solutions are both seeking? These questions were addressed at a conference this week in Philadelphia, Bio/Pharmaceutical Manufacturing Partnerships, organized by CBI in conjunction with Pharmaceutical Technology. Read more »
FDA’s Lucinda Buhse has been spearheading the agency’s spectral library of excipients as a means to improving supply chain security of the pharma industry, particularly focused on raw materials entering US borders (there are 300 entry points in total). She and Philip Merrill of IPEC wrote about the library last summer in PharmTech and Bushe gave an update on the program at the IPEC ExcipientFest Americas conference in late April 2012..
Hand-held instruments containing the libraries are being used at the borders to rapidly verify and authenticate materials via XRF, IMS, Raman, and NIR screening methods. Materials in question are then investigated at local FDA laboratories.
FDA has been collecting samples from the industry to add to the library but only has about 20% of its most wanted materials (see Table I in the July 2011 PharmTech article) thus far. Incoming materials must match a Hit Quality Index of 0.95. Bushe pointed out that the supplier or site of material used for the library has not had a significant or statistical impact on the library index to date. Samples are therefore being collected from various industry players and from various sites.
Looking ahead, FDA aims to fill its library with all the excipient samples it’s seeking and will work to finalize its classification and modeling strategies.