May 29, 2013
By:
Vaisala
Download the new Application Note ?Better Stability Studies: Match Your Environmental Monitoring & Mapping to FDA/ICH Guidance.? Learn how to minimize the risk of incomplete data from power or network failures during environmental mapping/monitoring applications and ensure stability study data complies with FDA/ICH guidance.
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June 5, 2013
By:
Jay Anbil, Steve Yoder, Colorcon
Medical prescription drug errors by doctors, pharmacists and patients account for 1.5 million incidences of sickness, injuries or deaths in the U.S. each year. Thirty percent of these unnecessary adverse events are attributed to human errors in identifying drugs and dosages. In fact, more people die from adverse drug events each year than from highway accidents, breast cancer, or complications from HIV. Learn how proper tablet design plays a crucial role in differentiating drug products and can mitigate the risk of medication errors.
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May 29, 2013
By:
Ashish Sarode, Catherine Cote, Peng Wang, David Worthen, Nisso America Inc.
High Viscosity Grade of Hydroxypropyl Cellulose (HPC) is thought as an effective controlled release (CR) material since it is a hydrophilic polymer. In this study, we investigated effects of viscosity, particle size, preparation method, and difference of controlled release polymer on drug release using Theophylline as model drug. The results showed viscosity, particle size, and preparation method affected the drug release, and optimization of particle size was more critical for DC method.
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May 29, 2013
By:
Jim Morris, NSF-DBA (USA) LLC
In the pharmaceutical manufacturing industry, our primary concern must always be the quality and safety of our processes and the products we produce. If we don't focus appropriately on developing robust quality management systems, we risk consumer safety and put our companies at risk of regulatory action. Learn more about how to achieve this in this white paper from the experts at NSF-DBA LLC.
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May 1, 2013
By:
Darek Kominek, MatrikonOPC
The Every Man's Guide to OPC is an easy-to-read overview of the most popular industrial open connectivity standar - OPC. This paper first introduces the main idea behind OPC, shows why OPC is different from conventional (often proprietary) communication protocols, and explains how OPC helps overcome the limitations of such native protocols.
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April 25, 2013
By:
Geoff Sheffrin, OBK Technology
USP water systems are highly specific in their requirements. To get there successfully is relatively easy BUT you are dealing with a large number of detailed requirements that MUST work in harmony to produce reliable Purified Water or Water for Injection - cost effectively and with minimum maintenance. Here's how.
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April 25, 2013
By:
DPT Laboratories
In recent years, the pharmaceutical industry has given greater priority and attention to quality assurance and regulatory compliance than ever before. With the FDA?s heightened focus on safety, regulatory agencies are increasing their presence in the manufacturing arena to ensure Current Good Manufacturing Practices (cGMP) are top of mind, and sponsors are placing greater responsibility for meeting cGMP requirements onto their outsourcing partners. While both sponsor companies and service providers must adhere to robust quality standards and undergo regular regulatory inspections, manufacturers are ultimately held responsible by regulatory agencies when it comes to adhering to cGMPs.
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April 25, 2013
By:
Ron Johnson, President Becker, NSF Becker
For companies seeking to prevent or remediate regulatory compliance violations, establishing a culture of quality is of the essence. In industries strongly affected by regulatory compliance, product quality is inextricably linked to a company?s well-being. Learn more about cultivating and nourishing a culture of quality in your firm.
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February 27, 2013
By:
Charlie Martin, Feng Zhang, James C. DiNunzio, Leistritz
Melt extrusion has been an established industrial manufacturing technology for more than 50 years. It is only in the last decade or so that it has emerged as a viable platform for pharmaceutical development. Today, applications of melt extrusion range from controlled release systems to oral bioavailability enhancement and show potential for small molecules and therapeutic peptides.
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