FROM THE EDITOR
HDMA Conference Examines A Holistic Approach To DSCSA Preparation
As the first Drug Quality and Security Act deadline approaches, pharma professionals around the globe are offering insight and advice in order to help with preparation for this legislation. While any Google search will return pages of helpful articles, the most beneficial information will be offered in real time at conferences and seminars arranged by industry organizations. One example of this is the 2014 Healthcare Distribution Management Association (HDMA) Education Traceability Seminar taking place in Arlington, VA from November 10th to the 13th. According to its site, the seminar will “include valuable insights, innovative approaches, and lessons learned as distributors and manufacturers successfully implement serialization and traceability technologies.”
OUTSOURCED PHARMA WEST CONFERENCE & EXHIBITION
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.
PHARMA MANUFACTURING INSIGHTS
Meeting Accuracy And Safety Objectives With Inspection And Weighing Technologies
New approaches to selecting and using inspection and weighing equipment can help pharmaceutical processors better meet accuracy and safety objectives.
Particle Testing in Cleanroom High-Pressure Gas Lines for ISO 14644
This paper provides guidelines for the testing of high pressure gases used in cleanrooms according to the cleanliness limits derived from the ISO 14644-1 cleanroom classification standard, the FDA cGMP guidelines and the EU GMP Guidelines. Specifically, this applications paper relates to satisfying the air particle concentration limits of Class 100 (ISO 5) where product is exposed to the air environment.
The Case For Connectivity
How a closed-loop system can optimize the supply chain.
New FDA Regs Help Secure The Global Supply Chain
A better strategy, coordination, and additional tools will help keep medicines and ingredients safe.
Product Safety In The U.S. Pharmaceutical Supply Chain: 3 Strikes And Yer Out!
Current legislation and pharmaceutical packaging fall short of protecting the product and the patient.
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.”
PHARMACEUTICAL ONLINE VIDEOS
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
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
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
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
The BIOTRAK® Real-Time Viable Pharmaceutical Particle Counter from TSI provides real-time information on microbiological contamination in pharmaceutical cleanrooms.
AT&T Inc. (NYSE:T) is a premier communications holding company and one of the most honored companies in the world. Its subsidiaries and affiliates – AT&T operating companies – are the providers of AT&T services in the United States and internationally. With a powerful array of network resources that includes the nation’s fastest and most reliable 4G LTE network, AT&T is a leading provider of wireless, Wi-Fi, high speed Internet, voice and cloud-based services.
Pall Life Sciences - BioPharmaceuticals Pall Corporation is a specialty materials and engineering company with the broadest-based filtration and separations capabilities in the world|We serve a diverse, global customer base with products that are used to purify raw materials, keep equipment running efficiently, ensure product quality and clean up and minimize waste
STERIS is a global leader in infection prevention, contamination control, surgical and critical care technologies, and more.
Fedegari Autoclavi SpA is the holding company of an Italian industrial group manufacturing customized machines, plants and the relevant components for the bio-/pharmaceutical and food industry worldwide. The know-how of the group lies in the field of sterile and clean processes and encompasses different technologies and products.
PHARMACEUTICAL ONLINE SUPPLEMENTS
The Information Source for the Pharmaceutical Manufacturing Industry
Welcome to Pharmaceutical Online, the premier sourcing site for the pharmaceutical manufacturing industry, find industry information on critical environment, particle sizing, pharma process control, pharma material handling, tablet production, pharma sterilizing, pharma cleaning, pharma filtration, pharma packaging, pharma inspection, & much more. Use our product showcase, and offline search service to expedite your discovery of new products and services. Our goal is to help buyers, like you, identify and select suppliers.
Pharmaceutical Online is part of the Life Science Connect media group. The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute. Please take a moment to join our community and discover the benefits of your free membership.
PHARMA EXPO 2014
UPCOMING TRAINING COURSES
1pm-2:30pm EST, Online Training
1pm-2:30pm EDT, Online Training
1pm-2:30pm EST, Online Training
1pm-2:30pm EST, Online Training
1pm-2:30pm EST, Online Training
LIFE SCIENCE WEBINARS
Aseptic Management of the Sterility Testing Process
Get the latest information on the aseptic management of the sterility testing process and find out some key insights into best practices.
Common Misconceptions in Freeze-Drying: Part Two
This is the second of two presentations addressing some of the most common misconceptions in freeze-drying (lyophilization) relating to formulations, process cycles, equipment and scale-up.
Overcoming Analytical Method Development Challenges: Analysis Of Nonclinical Dose Formulations From hERG Studies
This webinar is about overcoming analytical method development challenges with analysis of nonclinical dose formulations from hERG studies.
PHARMA INDUSTRY INTERVIEWS
Advances In Protein Production Bring New Options For Flexibility In Bioprocessing
Advances in protein production, including biomaterials and cell culture, have resulted in new methods for bioprocessing that can increase both yield and quality as well as decrease cost and time. Trisha Gladd, editor of Pharmaceutical Online and Bioprocess Online, spoke with Dr. Mike Ultee, Chief Scientific Officer at Gallus Biopharmaceuticals, about not just these new options but also the future of bioprocessing.
Serialization: Not Just Compliance, But Competitive Advantage
Todd and Todd interviewed Aiden Corcoran, CEO of Team Horizon, about some of the lessons learned in serialization and packaging and the ways the company applies these lessons to benefit its customers.
The Emergence Of The “Flex Factory”
On day two of Interphex, Todd and Todd interviewed Jack Giese, the director of commissioning and validation at Finesse Solutions.
The Impact Of Color Labeling Solutions On Tracking And Patient Safety
At Interphex 2014 Kelly Ng, product manager in healthcare with Epson discusses regulatory factors that have caused the labeling process to become more complex.
10.30.14 -- Dealing With Packaging Complexity; Managing Regulatory Submissions And Correspondence
10/30/14 Pharmaceutical Online Newsletter
10.28.14 -- Experts To Advance Drug Discovery For Neurodegenerative Diseases; SDV In Risk-Based Monitoring Misunderstood?
10/28/14 Pharmaceutical Online Newsletter
10.23.14 -- ISPE's Framework For The Prevention Of Drug Shortages
10/23/14 Pharmaceutical Online Newsletter
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