JVT Journal Articles
Vol. 13, Issue 3, Sep 2007

The three basic principles of quality assurance (QA) in the Food and Drug Administration1 (FDA) and World Health Organization2 (WHO) validation guidelines may be reproduced as follows: Quality, safety, and efficacy must be designed and built into the product. Quality cannot be inspected or tested into the product. Each step of the...
William Hall
Dr. Bill Hall, long time collaborator of IVT, international cleaning expert, mentor, and much honored contributor to FDA-regulated industry, was the Keynote Speaker at the IVT Cleaning Validation and Critical Cleaning Processes conference held in Chicago July 24 through 27. Because Doctor Hall is celebrating his 50th year of service as an active...
Choosing the best sampling plan for process validation and design verification testing is aided by knowledge of all of the options. An alternative and often more efficient option to the single attributes sampling plan is the double sampling plan for attributes testing. The process leading to choosing a plan requires the same risk determination...
Paul L. Pluta, Ph.D.
Laboratory studies are an important part of a cleaning validation program. Studies discussed are those in addition to typical laboratory quantitative analysis of swab or rinse samples. “Benchmarking” respondents commented on the value of laboratory studies, the types of laboratory apparatuses used for these studies and the applications of these...
Thanks to our readers for sharing their approaches to questions in the last issue. We received excellent responses, which once again demonstrated a variety of considerations and approaches to validation issues. Discussion of Questions #17, #18, and #19 are reported below. Additional responses to all “Benchmarking” questions are requested. All...
Miguel Montalvo
The Institute of Validation Technology held a conference on the topic of Cleaning Validation and Critical Cleaning Processes in downtown Chicago, Illinois, July 24 through 27. Along with the main conference, information was presented in three tracks: engineering, analytical, and validation.
William Hall
Cleaning Demonstration day was filled with live, hands-on displays by experts of various technologies, techniques, and equipment that could help participants develop, improve, and maintain their cleaning programs.
Cindy Green
The information in this article is intended to provide a systematic approach for establishing a method validation program. There are a variety of product types that require some level of evaluation and testing either at the raw material, intermediate, or final product level. There is no question that critical decisions may be made based on these...

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