May 17, 2012
By:Equipnet, Christopher Kinzie
Pharmaceutical Technology interviews EquipNet’s Director of Appraisals and Valuations, Christopher Kinzie, about how companies can benefit from professional equipment and business appraisal and valuation services. When you know what you have and what it’s worth, you limit risk of liability and maximize the value of your assets.
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April 25, 2012
By:DPT Laboratories
There are many factors to take into consideration when selecting or designing a packaging component. Working with a contract development and manufacturing organization early in the process helps eliminate packaging problems that may arise after the development stage.
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April 25, 2012
By:Shimadzu
Conducting instrument validation manually is a cumbersome task. This paper presents software that makes it easy to conduct an entire series of regulation and standards-related operations, from the setting of validation conditions to data measurement, pass/fail judgment, and file storage.
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April 25, 2012
By:Gayla Velez, SGS Life Science Services
When analyzing for trace metals using inductively coupled plasma (ICP), sample preparation is crucial. The key question is what is the best method to get the test article in solution?
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April 25, 2012
By:Paul Dupont, Ropack Inc.
As pharmaceutical companies face multiple pressures – to fast track innovative drugs and delivery systems, to meet increasingly stringent regulations and to grow resources despite increasing costs – outsourcing of packaging is reducing those pressures. Three essential characteristics are often overlooked, but essential, when choosing a packaging partner.
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April 25, 2012
By:Waters
This white paper provides an Introduction to Waters® T-Wave™ (Travelling Wave) Devices, a unique technology engineered by Waters to enable advanced mass spectrometry performance.
T-Wave Technology has been used in a number of creative and innovative ways to enhance the performance and functionality of Waters mass spectrometers, sometimes adding unique capabilities not possible by other means.
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May 1, 2012
By:Gina Ross
eCTD, XML, SPL, electronic signatures, 21 CFR Part 11, electronic gateway…these are the buzz words of the 21st century for pharmaceutical and biotechnology drug development. Today, these terms represent a challenge to each and every company in the pharmaceutical industry…from R&D to contract manufacturing to CROs and to regulatory agencies worldwide. Why? An organization must decide WHEN, not IF, they will integrate these new technologies and guidelines into their internal business processes, and if so, HOW?
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May 1, 2012
By:Richard Angelo, Ph.D., Beckloff Associates, Inc.
The development of increasingly more complex and sophisticated in vitro diagnostic (IVD) devices by clinical laboratories has precipitated FDA concern regarding a lack of product controls. These tests are often produced using available marketed kits, may include components purchased from a commercial supplier, and are offered for use as a diagnostic service. FDA contends that test ingredients or components used in the production of LDTs are essentially unregulated, therefore, of unpredictable quality. The regulatory boundary between FDA-regulated medical devices LDTs exempt from FDA jurisdiction remains somewhat blurred; however, the looming finalization of the CPG and IDVMIA guidance documents stand to better clarify this borderline.
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May 1, 2012
By:Beckloff Associates, Inc.
The highly publicized withdrawal of a number of unsafe drugs from the market over the last several years has led to strong criticism of FDA's ability to protect the public health, resulting in a call for fundamental changes in the United States drug safety system. A report commissioned by FDA in the wake of the Vioxx® withdrawal, and subsequently issued by the Institute of Medicine in 2006, concluded that the science of drug safety needed major improvements.
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