The Journal of GXP Compliance
Vol. 25, Issue 5, Sep 2021

Tim Sandle
This paper assesses the transfer disinfection process, the available technologies and critical bio-decontamination aspects, focusing on the important criteria for device assessment and operation.
Paul L. Pluta
This discussion describes concepts presented in “The Lessons of a Dishwasher – The Six Disciplines for Success,” and “Patience and Persistence – It’s All About Balance,” both taken from The French Laundry, Per Se by Thomas Keller. While the book is focused on recipes from the famous restaurant, there are valuable antidotes throughout that provide...
Tim Sandle
In this article the author provides an overview of the characteristics of microbial attachment and the essential considerations when developing a contamination control strategy. This review paper assesses the factors affecting finish and roughness, primarily in relation to microbial attachment to stainless steel, while considering other related...
Jeanne Moldenhauer
Warning letters and regulatory inspection observation reports (e.g., FDA 483) often provide useful information for assessing risks in your facility and preparing for upcoming inspections. A contamination control strategy is an integral part of pharmaceutical manufacturing, whether sterile or non-sterile. For this article we are going to look at a...
Karen R. Zimm
,
Renee Phillips
Some processes during drug manufacture may require storage of intermediate or bulk product before the next sequential unit operation is performed. In some instances, the storage time between sequential unit operations can be anywhere from a few days to a few months. This article review the regulatory requirements for storing bulk drugs, and time...
Tim Sandle
Within pharmaceuticals and healthcare, lack of critical thinking can result in poor decision making, and ultimately weak root cause analysis, poorly set CAPAs, weakly thought-out change controls and so on. This article is one of a three-part series about critical thinking in the context of pharmaceutical and healthcare organizations, and addresses...
Tim Sandle
While critical thinking can be learned and nurtured it can also be stifled if the workplace environments is not conducive to its development. Therefore, the pharmaceutical and healthcare workplace should be encouraging critical thinking and critical reading. In this article the author explores the critical thinking skills necessary for reviewing,...
Tim Sandle
With both change controls and root cause determinations, the proposal or outcome can be subject to criticism and contradictory perspectives. You are more likely to succeed in reaching agreement on an issue if you have rehearsed your argument and researched the topic. In this article, part 3 in a series, the author review critical thinking applied...
Kaiser Jay Aziz
CRISPR gene editing is a genetic engineering technique applied in clinical applications in which the genomes of living organisms may be modified. It is based on the principles of the CRISPR-Cas9 antiviral defense system. It is based on delivering the Cas9 nuclease complexed with a synthetic guide RNA into a living organism cell and that organisms...
IVT Staff
IVT is proud to announce that Advisory Board member, Valarie King-Bailey and her team at OnShore Technology Group were recently recognized by Inc. Magazine, ranking 4,171 in the magazine’s annual Inc. 5000 list, the most prestigious ranking of the nation’s fastest-growing private companies.
David Nettleton
In this episode we invite David Nettleton to be our guest and discuss some of the key topics from the CSV and Software Assurance week panel "The CSA Revolution," Held earlier this spring. The session provides a better understanding of the intent and scope of the FDA’s Computer Software Assurance guidance while highlighting CSA’s...
Karen Ginsbury
,
Nuala Calnan
This week, Stacey and Nuala invite a regular IVT contributor and industry disruptor Karen Ginsbury to innovate and revolutionize the future of quality management within the pharmaceutical and biopharmaceutical, and med device sectors. Karen will share her views on ICH Q10 and what must happen next.
Renee Phillips
This week, Stacey is joined by Renee Phillips to discuss the pros and cons of transitioning to a continuous manufacturing system. Batch production is time-consuming yet remains a popular and time-tested method used in the pharma industry today - but some industry leaders, along with the FDA, have taken steps toward or are now contemplating a shift...
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