The Journal of GXP Compliance
Vol. 26, Issue 1, Jan 2022

Paul L. Pluta and Alan M. Mancini
Example events in which product primary containers caused compliance problems are described. Pharmaceutical containers are safe for use in products and are generally considered to be non-reactive and inert. However, containers may be reactive under various conditions or when in contact with certain ingredients or formulations. Compliance...
Brandon T. Reif, David J. An, Varanya Chiayaperm, and Paul L. Pluta
This discussion provides fundamental information regarding medication safety and high-alert drugs. High-alert medications comprise a small and well-defined subset of critical therapeutic agents. Pharma industry designs product formulations, labeling, packaging, supporting information, and other product-related elements – all of which may...
Lori Richter
In this article, the researcher connects the dots from multiple thought leaders and industry experts that have participated in the Risk Revolution series of podcasts, which focuses on advancing the maturity of risk management practices across the Biopharmaceutical industry. Using these discussion points the author explores if the quest for a...
Tim Sandle
The focus in this paper is with personnel. This paper looks at the ‘testing’ element – the visual inspection of products by people and considers the nature of eye tests required to ensure that personnel are able to detect particulates that could be spotted by another person with acceptable vision under ideal inspection conditions. Acceptable...
Orlando Lopez
The DI Strategy Document, as part of the DI Governance system, is a critical record providing practical DI expectations and data management to ensure integrity in the GMP data as part of the regulated entity. The general principles of good documentation practices (GDPs) can describe the DI expectations for the data lifecycle, ensuring its...
Nilesh Shah and Madhuri Powar
Membrane filters with a 0.45-micron pore size have long been recognized as standard for microorganism recovery, growth, and enumeration in microbial test procedures. This study supports the use of 0.45 µm pore size for recovery of microorganisms, versus the .22-micron filters which offer lower recovery overall/
Karen R. Zimm
Renee Phillips
Titanium Dioxide (TiO2) is a naturally occurring mineral utilized by the pharmaceutical and other industries including paint, cosmetics, and food. A current hot topic is Europe’s potential safety concern over the use of TiO2 in foods and the potential impact on the use of TiO2 in medicines. This article addresses the current debate.
Jeanne Moldenhauer
According to European Compliance Academy, there were 21 Warning Letters issued relative to issues with review of Production Batch Records. Depending upon your point of view, these may be either production issues or quality issues, or both. This paper describes considerations for conducting investigations relative to deviations that occur in the...
Tim Sandle
Probing the cause of human error can be achieved through an interactive process, such as by asking ‘why’ multiple times until the answer emerges, this article looks more closely at why human error may occur.
Kate Coleman
ICH Q9 Quality Risk Management was first published in 2005 and a long-awaited revised draft was released for public consultation in November 2021. In this blog post we review the changes and additions, as well as discuss the impacts and shortcomings.
Ferdi Steinmann
This week, Ferdi Steinmann shares his three things you can do to bring intelligence into everything you do. Ferdi breaks down the barriers to intelligence and helps show the path to overcoming the tsunami of data in life sciences. Ferdi covers medical innovations, patient applications, wearables, and the internet of medical things.
Lori Richter
Nuala Calnan
In this episode we celebrate the Anniversary of Risk Revolution, a series of Voices in Validation. As we look back at a full year's worth of interviews focused on ways to advance the maturity of risk management practices through topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they...
Chinmoy Roy
Digital transformation in the pharmaceutical industry is crucial for better patient care, cost-effectiveness, greater transparency, improved production, and drug development. Across the pharmaceutical industry, companies are at varying stages in the adoption of digital technologies, but it is clear that the recent COVID pandemic may have...
Kelly Simpliciano
Kelly Simpliciano hosts a discussion on GXP inspection principles and the changes in processes and expectations stemming from the Covid-19 pandemic. More work than ever is being completed by virtual connections, remote activities, and through systems and processes more reliant on collaborative team efforts and digital technologies. Understanding...
Tim Sandle
Investigations that conclude that operator error was the sole cause are rarely acceptable. Underpinning the ‘human error’ there will be a number of underlying causes that created the environment in which human errors were inevitable. This article looks at a process of defining human error and provides some guidance on constructing a checklist for...
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