JVT Journal Articles
Vol. 19, Issue 3, Sep 2013

In the second part of a presentation from Validation Week Canada, Dawn Tavalsky analyzes the basics of risk management; cleaning validation, including cleaning soils and equipment; the basics of the US Food and Drug Administration's approach to process validation; and the basics of quality systems.
Jane Weitzel
A new approach to analytical procedures has arrived. For production processes, quality-by-design (QbD) is being used successfully; the same QbD approach can be applied to analytical procedures. In addition, there is now a technique to definitively link the data to its intended use. These are exciting times for testing laboratories and the users of...
Thierry Wagner
,
Michael H. Scholla, Ph.D.
The medical device package design and packaging process are critical steps for the production and distribution of terminally sterilized medical devices. Guidance on design validation and process validation is widely available, but guidance on changes that require revalidation activities is relatively limited.
Timothy J. Fields
The last decade has brought about a number of changes to how pharmaceutical companies address validation. These changes have been brought about primarily by regulatory changes and the economy. Rather than focusing on the “documented evidence” aspect of validation, companies and regulators are switching the focus to “where is the biggest risk” and...
Juan Carlos Raposo
Capillary ion electrophoresis (CIE) with indirect ultraviolet (UV) detection was used for separation and quantification of several inorganic anions such as bromide, chloride, sulphate, nitrite, nitrate, fluoride, and phosphate in different natural and wastewater samples. This paper illustrates setting-up and interpreting a validation methodology...
Amored Amaya
Process validation is defined as the collection and evaluation of data from the process design stage through the commercial production that establishes scientific evidence that a process is capable of consistently delivering quality product and thereby also assuring reliability of supply.
Mary Sexton
The design of a pharmaceutical water system for the active pharmaceutical ingredient (API) industry will depend on the type of API process (e.g., intermediate API, final API, API cleaning): Final API: This is the final product manufacturing step in the process and is the substance in a pharmaceutical drug that is biologically active....
Manuel Salinas
,
Sharan Ramaswamy, Ph.D, FAHA
Design of experiments (DOE) methods are very commonly used for process validation. In this study, we employed the Taguchi approach in order to develop an optimal process for the maximization of oscillatory shear stress environments (OSS). OSS has been associated with increase in cellular activity and has been linked to healthy gene expression and...
Bernard McGarvey
,
Brian K. Nunnally
,
John McConnell
When I first joined the ranks of employed engineers (back in the early 80s), I worked in a technical services organization where part of my job responsibilities was to use process control to improve the performance of the manufacturing processes at the site. My job was to find out from the chemists and other engineers what the perfect process...
Rizwan Sharnez, Ph.D.
,
Angela To
,
Arun Tholudur, Ph.D.
Methodologies for estimating experimental parameters for small-scale cleaning characterization studies are described in this series: dilution of process fluids (e.g., process soil, cleaning solution, or rinse water) during cleaning is discussed in this paper; worst-case fluid velocity and soil load will be discussed in subsequent parts....
John E. Lincoln
On August 13, 2012, The US Food and Drug Administration announced the release of their new guidance document on wireless medical devices, entitled Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff. The draft of this guidance was issued on January 7, 2007, soliciting public comment.

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