The Journal of GXP Compliance
Vol. 26, Issue 2, Mar 2022

Tim Sandle
Batch release testing is the final safety check that pharmaceutical manufacturers must perform. Before any therapeutic product is declared ready for distribution, the manufacturer must thoroughly analyze batch processing data and test samples to check that the product meets all safety and quality controls. Not a single dose from a batch should...
Paul L. Pluta
Introducing medication safety considerations to pharma industry personnel with these responsibilities should help integrate potential safety issues into industry practices to minimize potential medication problems – a positive outcome for healthcare practitioners, for patients, and for pharma industry. Content addressed in the present discussion...
Brad Bartels
,
Paul L. Pluta
Calculations Roundtable is a new IVT feature that will provide readers an opportunity to discuss typical calculations related to pharmaceutical compounding and product use. Correct product calculations are vital in product design, development, and analysis. After commercialization, calculations are equally vital in healthcare practice including...
Nishant B. Thakar
,
Paul L. Pluta
Compounding Forum (CF) is a new IVT feature that will provide readers an opportunity to discuss pharmaceutical compounded formulations, processes, problems, and related topics. Pharmaceutical compounding is a specialized skill based on principles of science. The New England Compounding Center disaster in 2012 alerted the entire world population...
IVT Staff
Late last month after much hard work and deliberation the FDA released a draft rule harmonizing the Quality System Regulation – 21 CFR, Part 820 (QSR) with ISO 13485:2016. The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers, by more closely aligning domestic quality system requirements and...
Tim Sandle
How effective is the Quality System in your organization, be that pharmaceutical or healthcare related? While there is copious advice as to how a Quality System can be established, this does not necessarily help with evaluating the effectiveness of the system. This article presents some points for consideration when establishing a Quality System,...
Tim Sandle
This article looks at some best practice points concerning the presentation of data in terms of a report. Reports are often supplemented by tables, charts, or through the use of figures. Data needs to be presented well in order to make a reasoned argument and hence the report plays an important role in the critical thinking approach.
Tim Sandle
Looking for patterns in data is a key part of many sectors, including those working in pharmaceuticals and healthcare. While software packages are available to automate this task and, for highly complex data, machine learning can be used, reviewing data continues to matter event for the simpler aspects of life in the sectors. This includes...
Peter Small
There are unique challenges inherent to emerging technologies in clinical trials development, scale-up, and manufacture. As we begin to harness the data delivered through AI, and further refine the processes around automation, IVT Network strives to bring to light some of the most innovative products and uses for the benefit of the entire life...
Scott Smith
As we begin to harness the data delivered through AI, and further refine the processes around automation, supply chain, new norms around surface contamination and sanitization, IVT Network strives to bring to light some of the most innovative products and uses for the benefit of the entire life sciences industry.
Ronald Schardong
We have entered an era of accelerated digitalization in Life Sciences. Innovation has been thrust upon many across industries as a need to work remotely, automating tasks and virtual collaborations were necessary during the pandemic. Maintaining this accelerated pace, fully embracing the adoption of technology and automation, is the next hurdle we...
Lori Richter
,
James Vesper
,
Nuala Calnan
,
Valerie Mulholland
In this episode, series coordinator Nuala is joined once again by Risk Revolution co-hosts, Valerie Mulholland and Lori Richter with another old friend of the IVT network, Dr. James Vesper. Dr. Vesper will share his unique insights and deep learning on a very interesting aspect of RBDM, Risk Appetite, and the distinction between that and Risk...
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