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402 Results
Type: Article
Section: Industry News > Regulatory
Pharmaceuticals
Industry Collaboration Sheds Light on Serialization
Serialization in pharma packaging is a complicated undertaking for anyone, but CMOs and their customers face additional challenges because responsibilities aren’t always clear-cut. A trend toward industry collaboration, even among competitors, is helping to shed light as companies share their successes and lessons learned.
December 2, 2015
An end-to-end view of a serialization compliance program. Source: Supply Chain Wizard, LLC.
Regulatory
FDA’s GE Salmon Announcement Sparks Controversy
Agency announces genetically engineered salmon is safe, drawing a CFS lawsuit. Salmon will be regulated under new animal drug provisions. GE products also have labeling implications.
November 20, 2015
Agency announces genetically engineered salmon is safe, drawing a CFS lawsuit. Salmon will be regulated under new animal drug provisions. GE products also have labeling implications.
Materials
Serialization: An Expert’s Lessons Learned and Current Trends
Serialization brings many challenges. Considerations, like ensuring labels are readable throughout the supply chain and compartmentalizing line solutions, can be key to success.
November 16, 2015
Serialization timing around the world. Image courtesy of Pharma Logic Solutions, LLC
Pharmaceuticals
11 questions to help you protect pharma packaging personnel
Concerns over contamination often overshadow concerns for workers’ safety. Highlighted here are key questions to ask during your risk evaluation.
November 5, 2015
A banding system is used by cross-functional teams to categorize the risk levels of drug properties. Image provided by IPS – Integrated Project Services, Inc.
Pharmaceuticals
Change in thinking needed for women in packaging careers
An interview with Ivette Larralde-Valdes, Sr. Q.C. Compliance Specialist, Noven Pharmaceuticals, Inc.
November 4, 2015
Ivette Larralde-Valdes conducts auditing of a microbiology water sample at the Purified Water System Utility area.
Medical Device/Packaging
Narrowing focus provides career with impact
A 'Women in Packaging' interview with Laure L. Larkin – M.Sci., CPP, Associate Director—Global Stability, R&D Analytical Science & Technology, Ethicon, Inc.
November 3, 2015
From left to right, Gina Maroney, Corinne McGill, Dale Marcuccilli, and Laure Larkin around the Instron machine set up for a lid tensile test. (Missing: Binal Shah).
Materials
Delivering what patients need next
Award-winning Multipack carton from supplier-partner Rondo-Pak helps provide safer clinical trials for F. Hoffmann-La Roche AG.
October 20, 2015
MANUAL PACKING. An operator places a glass vial into the clinical trials carton.
Robotics/Automation
Medical device firm wins with barcode labeling software
CFR enterprise barcode labeling software helps QTS reduce risk, increase efficiency, and become compliant with UDI and FDA 21 CFR Part 11 regulations.
October 14, 2015
Minneapolis-based Quality Tech Services (QTS provides medical device packaging assembly, kitting, and packaging services.
Packaging/Filling
Capsule filler enhances Sharp Clinical Services' production
Machine’s in-process weight control system and tablet feeder provide ‘radical change’ to the company’s capsule production.
August 13, 2015
Machine’s in-process weight control system and tablet feeder provide ‘radical change’ to the company’s capsule production.
Robotics/Automation
Losan Pharma adds MES for solid dosage production
Contract manufacturer in Germany to interface Werum’s PAS-X MES. Once fully integrated, it will comprise a WMS and track and trace to address counterfeiting.
August 12, 2015
Stick-pack production at Losan Pharma.
Inspection
Particle inspection equipment delivers savings, benefits
Custom particle inspection labeling machine with camera-based inspection set to be operational at a pharmaceutical company by late 2015.
July 27, 2015
Overall with remote inspection table for two operators.
Labeling/Printing
On the front lines of serialization
Successful implementation requires interconnecting packaging equipment, materials, and components so they are dependent upon each other.
July 24, 2015
Seen here is a Weiler RL-420 labeler with X-3 label head and Domino laser printer.
Packaging/Filling
Digital printer ‘XAPS’ would-be counterfeiters
Digital carton printing company OTC Group helps its customers thwart counterfeiting and theft with Xerox tracking system.
July 24, 2015
XAPS shows a serial number reversed out of the grey bar in front, with an enlargement of microtext on the top flap of the carton.
Pharmaceuticals
DMFs can provide medical and pharmaceutical packaging benefits
Although not required by law or FDA regulation, Drug Master Files provide information about facilities, manufacturing, processing, packaging, and storage of drugs to support New Drug Applications.
July 22, 2015
Plastics scientists work to meet medical packaging standards and FDA requirements.'
Medical Device/Packaging
Catching the wearable device wave
Commercial products and technology developments in clinical trials offer potential for disruptive change in treating patients.
July 20, 2015
Braebon's DentiTrac® is an integrated wearable micro-recorder and web cloud portal combination for the objective measurement of oral appliance compliance measurement for sleep apnea.
Inspection
Not your grandparents’ clinical trial
Everyone from the FDA to professional associations are investing time, money, and resources into upping the stakes when it comes to clinical trials.
July 15, 2015
Sharp Clinical Services is expanding its storage and packaging facilities in the U.S.
Adherence/Delivery
What’s new in personalized medicine?
A new PwC/Personalized Medicine Initiative Green Paper describes patient benefits. Meanwhile, Grand View Research predicts the global genomics market value to top US$22 billion by 2020.
June 12, 2015
This photo shows capsules with a DNA imprinted on them.
Supply Chain
Packaging helps secure canine reproduction specimens
South Mountain Pet Care and Canine Reproduction Center uses Cryoport’s cold chain shippers for cryogenic canine specimens.
May 27, 2015
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