FROM THE EDITOR

  • 2nd Draft Guidance Under DSCSA Offers Clarity For 3PLs As January Deadline Approaches
    2nd Draft Guidance Under DSCSA Offers Clarity For 3PLs As January Deadline Approaches

    Earlier this month, the FDA announced the availability of the second draft guidance under the Drug Supply Chain Security Act (DSCSA), titled The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers. While clarifying information is provided, the guidance is still in draft form and more information from industry will need to be collected in order to drive it to a finalized state.   

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OUTSOURCED PHARMA WEST CONFERENCE & EXHIBITION

  • Why We Took A Different Approach To Planning A Conference
    Why We Took A Different Approach To Planning A Conference

    Like you, I have attended a lot of educational events and conferences over the years. I’m sure we both could list some that were unique, valuable, and memorable while others could be simply categorized as “been there, done that.” And since time is my most precious resource, the last thing I want to do is spend this ever-diminishing asset on attending — or planning — a conference that’s just like all the rest.

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PHARMA MANUFACTURING INSIGHTS

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PHARMA CONTRIBUTING EDITORS

  • UPS Worldport: A Transportation And Logistics Modern Marvel

    One of the joys of working in media is the amount of travel I get to do as part of the job. While boarding planes and sitting in airports can become exhausting and tedious at times, I do get to visit some pretty amazing places that I otherwise would not have the opportunity to access. Visits to major cities like Boston, Chicago, and NYC are always enjoyable, as are visits to landmark places such as the New York Stock Exchange. Since I have been involved in the life sciences space, I have also gotten to visit some pretty memorable manufacturing facilities such as CMC Biologics, Therapure Biopharma, and Gallus Biopharmaceuticals.

    Last week, I had the privilege of attending a tour of the enormous UPS Worldport facility in Louisville, KY. To say this hub is incredible would be an understatement. The place is more amazing than Disney World, and should probably be considered as a contender for the eighth wonder of the modern world.

  • Pain In The Chain Survey: Time To Capitalize On Untapped Opportunities

    UPS has released its 7th annual UPS Pain in the (Supply) Chain Survey of executives in the pharma, biopharma, and med device industries. While this latest version of the survey shows executives still have concerns over the economy, rising costs, and regulatory challenges, there are opportunities companies can capitalize on to help move the industry forward.

    On the positive side, the growth of the global population and the middle class, along with a rise in the median age has created a growing demand for healthcare services. The report notes in order to capitalize on these new opportunities, companies will need to move quickly to make strategic changes to their supply chains. Unfortunately, supply chain change seems to come slowly, and in the current risk-inherent environment, may be impeding growth in the industry.

    While some companies are reacting to emerging opportunities by transforming their supply chains, the report states the winners in tomorrow's healthcare marketplace will be those companies that make their supply chains more flexible and efficient, and begin making those changes as soon as possible. Those that don’t may be taking on the greatest risk of all.

  • The Challenge Of Managing Regulatory Submissions & Correspondence

    Life science organizations produce large volumes of documents necessary for submitting applications to regulatory agencies. They need to have records of those documents as well as all related communications from sites around the world. This creates a situation that can be rather daunting.

    Sponsors must first make sure all documents are going through the proper review and approval cycle and that controls are in place to meet regulatory requirements such as 21 CFR part 11. Once the documents are published and ready for submission to the regulatory agency, they are typically stored on a file share. Although that file share has access controls in place, it will not have granular-level access controls.

  • ISPE Releases Drug Shortages Prevention Plan At Annual Meeting

    ISPE has released its Drug Shortages Prevention Plan at a media conference held during its annual meeting at Caesars Palace in Las Vegas. Present at the conference were new president and CEO John Bournas, strategic advisor John Berridge, and Drug Shortage Prevention Plan leaders Joe Famulare, Paul D'Eramo, Donna Gulbinski, and Sam Venugopal.

  • ISPE Set To Address Drug Shortages At Annual Meeting

    Drug shortages continue to plague the pharmaceutical industry. According to a GAO report on shortages, dated February 2014, the number of shortages continues to increase in the U.S., as well as around the world. In 2007 there were 154 shortages, 114 new shortages and 40 ongoing from a prior year. In 2012, there were 456 shortages, 195 news ones and 261 ongoing. As of June 30, 2013, there were already 73 new shortages and 288 ongoing.

    The public health importance of these shortages cannot be overemphasized. Shortage situations have included zinc for parenteral nutrition in neonates and premature infants, doxorubicin for ovarian and other cancers, and Propofol for anesthesia.

    Clearly something needs to be done. “ISPE believes efforts to address this complex and multi-faceted problem of drug shortages requires close collaboration and clear communication between the pharma industry and global health authorities,” says Francois Sallans, VP and chief quality officer for Johnson & Johnson, and presenter at the 2014 ISPE-FDA CGMP Conference. “We believe The Drug Shortages Prevention Plan being assembled by ISPE will provide guidance to pharma and global health authorities to manage drug shortages more effectively. But more importantly we are looking into ways for the two groups to manage these shortages more proactively as well. That is an important component that we need to have in place in order to make these shortages rare, but short-lived.”

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PHARMACEUTICAL ONLINE VIDEOS

  • Global Study Reveals The future Of Temperature Control Packaging
    Global Study Reveals The future Of Temperature Control Packaging

    Sonoco ThermoSafe, a leading global provider of temperature assurance packaging, has revealed the results of its survey entitled “Assessing the Future of the Cold Chain Industry.” The survey highlights forward-looking trends in areas that significantly impact the cold chain industry – including environmental, trends, logistics and products and services. The survey’s 165 respondents spanned more than 20 countries and five continents.

  • Introduction to Multivariate Data Analysis
    Introduction to Multivariate Data Analysis

    Brad Swarbrick, Vice President of Business Development at CAMO Software, gives a short introduction to multivariate data analysis, discusses some of its applications and how these powerful analytical tools are being used to improve products and manufacturing processes in a wide range of industries.

  • Introduction to Pharmaceutical Bag Filling and Sealing Equipment
    Introduction to Pharmaceutical Bag Filling and Sealing Equipment

    Umbra bag filling and sealing machinery for all sorts of dry products in the food, pharmaceutical, chemical, and agricultural industries. A single Umbra packaging machine can fill bags of any material with varying fill weights and with different closure techniques, providing an extremely versatile solution to customers looking for high flexibility.

  • What Is mHealth? Video
    What Is mHealth? Video

    AT&T mHealth Solutions are on the cutting edge of transformation in healthcare and offer solutions that enable health enterprises to engage patients, improve outcomes and lower costs.

  • Real-Time Information On Microbial Contamination In Pharma Cleanrooms
    Real-Time Information On Microbial Contamination In Pharma Cleanrooms

    The BIOTRAK® Real-Time Viable Pharmaceutical Particle Counter from TSI provides real-time information on microbiological contamination in pharmaceutical cleanrooms.

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    ISPE

    ISPE, the International Society for Pharmaceutical Engineering, is the world's largest not-for-profit association dedicated to educating and advancing pharmaceutical manufacturing professionals and their industry. Founded in 1980, today ISPE serves 23,000 members in 90 countries.

  • Bürkert Werke GmbH
    Bürkert Werke GmbH

    Throughout the world, Bürkert is synonymous with competence in fluid control systems. Our customers receive complete system solutions from Bürkert combining state-of-the-art technology with the highest degree of cost effectiveness.

  • Bioquell Inc.
    Bioquell Inc.

    Bioquell is a world leader in the field of biological decontamination providing expert assistance in contamination control issues, from initial consultations to project implementation and validation.

  • Sonoco ThermoSafe
    Sonoco ThermoSafe Breakage Protection|Insulation|Temperature Maintenance

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