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cold chain forum takes global, holistic perspective

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By admin on Wed, 04/22/2015 - 16:00

among the event&rsquos highlights is a new u.s. pharmaceopeia 1083 guidance chapter aimed at pharmaceutical counterfeiting in the supply chain.by jim butschli, features editorenlargein the nottoodistant future, it could well be that a nurse or medical care practitioner will scan a package and verify that it is the right product and that it has not been tampered with and is not counterfeit.that&rsquos a prediction from geoffrey glauser, biomedical advanced research and development authority, u.s. department of health &amp human services at the 9th annual cold chain &amp temperature management global forum sept. 28 in philadelphia.he said, &ldquotrack and trace is going to become much more significant throughout the entire supply chain, especially with california demanding product pedigrees for pharmaceuticals in the 20152017 time frame.&rdquo at some point, glauser noted, every unit of sale will require serialization, a product identification to help prevent counterfeiting. a database could include every product from every manufacturer. &ldquothere are implementation programs in brazil, turkey, and argentina, with pilot programs in sweden and germany. this is on the horizon, and it&rsquos coming,&rdquo he said.new 1083 chapterdr. mary foster, chair, packaging and storage expert committee with the u.s. pharmacopeia, and vp with aphena pharma solutions, noted that a new chapter in the 1083 guidance has &ldquothe ultimate goal to prevent adulterated and misbranded materials from entering the supply chain and to detect counterfeiting or diversion.&ldquothe new 1083 chapter is similar to 1079 except that it includes active pharma ingredients and excipients, packaging components, and medical devices,&rdquo she said, &ldquoit takes in the whole picture of the movement of a drug. we need industry and subject matter expertise and feedback. it&rsquos a guidance document, not a mandatory one as are chapters numbered under 1,000. this is a brand new chapter, and you are the first people to see it.&rdquobigpicture issuesglauser noted, &ldquoso many people feel they don&rsquot have any influence with policy setting, and this new 1083 chapter gives us an opportunity to have that input.&rdquoat the beginning of the event, glauser recommended that attendees think holistically about the variety of content at the event, including sessions that weren&rsquot &ldquocold chain&rdquocentric. &ldquothese are all pieces of a puzzle in the overall supply chain that bind this group together.&rdquoone example of this was vic pervaaz&rsquos presentation, &ldquotomorrow&rsquos landscape for the pharmaceutical business in a global industry.&rdquo pervaaz, senior vp, corporate transactions and transformation, pharma industry initiative leader with aon hewitt, spoke about mergers and acquisitions in a global market, among other broader issues.he said, &ldquowe have progressed from smallmolecule pharmaceuticals dominating the industry to today&rsquos generic market growth due to patent expirations. the biologics market is growing faster, and in 10 to 15 years, the biosimilars will be the future, and there will be a prominent increase in the need for the cold chain.&rdquoglobalization&rsquos increasing role means companies will no longer look for &ldquohot&rdquo geographic regions to set up shop, said pervaaz. instead, companies need to examine how integrating global business fits into future supply chain plans. he noted a need for companies to build and train a talent pool equipped to understand and thrive in a new global business environment.he believed that in the future, pharmaceutical markets will become less segmented, and that countries such as china, india, and those in south america &ldquowill become centers of excellence, increasing faster than north america and europe.&rdquotemperaturecontrolled fun factspreshow promotional literature on the cold chain forum yielded some interesting news based on survey responses. these included the following&bull the top two greatest concerns in pharmaceutical importation were temperature deviationsexcursions, and counterfeit product leading to adverse events.&bull chain of custody collaborative supply chain partnership was voted the most important initiative in cold chain operations.&bull air was by far the most used transportation mode, cited by 64 of respondents, compared to 18 each for ocean and road. in a separate question, 45 of respondents also said air transport is the fastestgrowing mode.the 10th anniversary special event for the cold chain &amp temperature management summit is scheduled for feb. 2729, 2012 at the hyatt regency, toronto, ontario, canada.&nbsp

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plas-tech engineering - Supplier for COC/COP PFS Syringes
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