FROM THE EDITOR
Compliance In The Supply Chain: 3 Best Practices To Manage Regulations Around The Globe
As if it isn’t challenging enough to maintain compliance with the regulation agency of the country you’re located in, anyone doing business in pharma also has to maintain compliance with any other countries for which they want to do business. Meeting the regulations of every point along the supply chain is necessary for both the manufacturer as well as the logistics provider who is transporting the product, but what is the best way to achieve this?
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
IMD-W™ Microbial Challenge Test Results
This fact sheet provides a summary of microbial test results obtained with the IMD-WTM-series instantaneous microbial detection™ system for water.
Powder Processing’s Major Challenge: Quality Assurance And Quality Control Need Quality Test Methods
Quality Assurance: The maintenance of a desired level of quality in a service or product, especially by means of attention to every stage of the process of delivery or production.
A 15 Minute Guide For Life Sciences Quality And Manufacturing Organizations
Life Sciences quality and manufacturing organizations face three critical industry forces: increasingly stringent regulation; globalization; and virtualization of supply networks.
3 Ways Mobile Supply Chain Solutions Make A Difference
Try to remember the days before ubiquitous smart mobile devices. They seem like prehistoric times now, but it was less than 10 years ago.
PHARMA CONTRIBUTING EDITORS
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.”
What Can You Learn From The Educational Planning Process Of BIO?
In my role as the 2015 co-chair of the BIO International’s educational planning committee, I am privy to what goes into creating one of our industry’s largest annual events. As many of you are involved in organizing your own customer educational programs (e.g., The Emerson Exchange) or have been asked to serve on an event planning committee, I thought a behind the scenes look into how BIO goes about the process would be helpful to your efforts. Here are some of the best business practices I have witnessed thus far.
Innovation In Clinical Trials: Is It Time To Change The Paradigm?
“People hate change. This is true in the life sciences industry and everywhere in the world. I think it’s a major, major problem.”
That statement, by Glen de Vries, president of Medidata, seems to sum up the challenge many have with trying to bring down the cost of clinical trials. To bring down costs we need to implement new, efficient, and available technologies. Unfortunately implementing new technologies involves change, which many people in this industry do not seem to want to embrace.
Hopefully, that attitude may soon be changing. One of the trends de Vries has seen in the past year is a focus on innovation originating at the executive level. More managers, especially those in the C-suite, are saying we need to figure out how to do things differently.
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.
Charles Ross and Son Company
Ross serves the requirements of the Pharmaceutical industry, in virtually every industrialized country around the world. We have the experience and production capacity that no other manufacturer of specialty mixing and blending equipment can match.
Founded in 1980, Marken is focused on supporting Life Science companies assure the quality and integrity of clinical trial specimens and vital medications through the logistics chain. For nearly two decades, Marken has extended the reach of Pharmaceutical companies, research laboratories and clinical trial research organizations bridge the distance between patients and life science investigative resources.
Southwest Airlines Cargo
At Southwest Airlines Cargo®, we understand the urgency of pharmaceutical shipments and know that sometimes overnight is not an option. With Relentlessly Reliable® air cargo service to over 90 destinations, we provide exceptional care so your time critical shipment will arrive ontime, as planned.
Capsugel offers capsules for the pharmaceutical and dietary supplement industries in multiple polymers — gelatin, HPMC, and pullulan.
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
As the highly anticipated November debut of Pharma EXPO approaches, we’ve developed this resource center for our readers to access the most relevant information about the event.
UPCOMING TRAINING COURSES
1pm-3pm EDT, Online Training
1pm-2:30pm EDT, Online Training
1pm-2:30pm EDT, Online Training
1pm-2:30pm EDT, Online Training
1pm-2:30pm EDT, 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.
10.16.14 -- Challenges When Qualifying A GMP Analytical Laboratory; Solutions For Container Closure Integrity Testing At Pharma Expo
10/16/14 Pharmaceutical Online Newsletter
10.14.14 -- ISPE Thought Leaders Discuss Regulatory Mythbusters: Sorting Fact From Fiction
10/14/14 Pharmaceutical Online Newsletter
10.09.14 -- How Can You Avoid Becoming The Next Recall For Particulates?; FDA News Roundup
10/09/14 Pharmaceutical Online Newsletter
1pm-3pm EDT, Online Training