The robust ShockWatch product portfolio includes temperature, tilt, impact, vibration, and humidity detection systems. ShockWatch also provides complete cold chain services to not only monitor facilities, vehicles, and cargo, but also provides cold chain analysis and compliance support for customers. Services include 24/7 real-time monitoring, regulatory compliance gap analysis, packaging design and testing, shipping studies, temperature mapping, and transport qualification (IQ, OQ, PQ) and validation studies. Visit shockwatch.com to learn more or request a free consult.
By Trisha Gladd, Editor, Pharmaceutical Online and Bioresearch Online
When it comes to the topic of serialization and California's 2015 deadline, much of the discussion focuses on cost and compliance. What are the costs associated with preparing your company for California's ePedigree Law? With a history of delays in this law, as well as a federal mandate, is preparation even necessary?
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By Reynaldo Roman for Marken
On December 21, 2012, the U.S. Fish and Wildlife Service (FWS) finally addressed an issue that has been of significant debate among importers of Chinese hamster ovary (CHO) cell specimens and trade experts. FWS informed the trade community that only shipments of actual CHO “cell,” “cell cultures,” and “cell lines” are regulated by the agency and require an import/export license for trade.
By Benjamin Frey, Senior Director, Compliance, ProPharma Group
The expectations of manufacturers and sponsors to control activities and materials provided by their suppliers has been magnified due to FDA-regulated products and the rapid expansion of globalization of the supply chain. With increased responsibilities, each organization needs to ensure that their suppliers provide services and materials that are fit for purpose through a Supplier Quality Management Lifecycle Model. The following includes recommended steps for developing and managing a supplier management program.
By David A. Loy, Senior Director of Quality and Regulatory Affairs, Aphena Pharma Solutions
With every recurrence of confirmed counterfeit drug product in the pharmaceutical supply chain, the pressure increases to establish a national standard for pharmaceutical track-and-trace solutions. Although a universal standard has yet to emerge, there is one set of requirements that is currently driving action: the California Board of Pharmacy's ePedigree.
By Paul Dupont, Ropack
Audits by the Food and Drug Administration (FDA), historically a source of angst, may be generating even more concern. Recently, the FDA has escalated its cGMP compliance inspections by enforcing increasingly complex regulations, gaining greater access to records, and conducting audits more frequently — up from .06 to .09 per year, according to Bloomberg News.
By Brian Garrett, Product Manager, Labconco Corporation
Unlike most industries and professions, the very nature of laboratory science is hazardous. Technicians and researchers are required to handle, and are in close proximity to, substances, agents, and materials that are inherently risky.
By Lori Clapper
Shawn Smith is the senior director of upstream bioprocess technologies for Pall Life Sciences. I had the chance to talk with him about the challenges that exist within the cell culture space, the issues of standardization, as well as solution trends that could improve the end user experience.
By Robert Rosen, Filamatic
There are a few questions to ask yourself when determining which liquid filling machine is right for your project. As each machine is unique in its filling techniques and performance abilities, certain questions that are asked will help to narrow down the choices and select a machine that will best suit your application.
By Ed Emerson, MOCON, Inc.
In a world full of hungry microorganisms, it is critical that medical devices, designed to heal, do not inadvertently do the opposite by infecting the patient. To prevent infection, a device’s packaging or “sterile barrier system” must maintain sterility over the product’s entire shelf life.
By Mark A Collins, Ph.D., BioFortis, Inc.
In this white paper we review the key drivers impacting “traditional” biobanking and detail the challenges such biobanks face in delivering new biomarker-based research. To facilitate the discussion of approaches to overcoming these challenges, we introduce the concept of Next Generation Biobanking and define the attributes an “ideal” Next Generation Biobank would need to drive effective biomarker-based research. Finally, we demonstrate the benefits of adopting a Next Generation Biobanking approach, with a case study in cancer biomarker discovery.