The Journal of GXP Compliance
Vol. 24, Issue 6, Nov 2020

Paul L. Pluta, Bernard Hsu, Alan M. Mancini and Richard Poska
Several recent news stories describing fatalities caused by microbial contamination of food have been widely reported. These stories described the potential dangers of microbial contamination associated with food preparation in the home. They should be viewed, however, in a broader context – why did contamination occur and how might the fatal...
Paul L. Pluta
A revision to ICH Q9 Quality Risk Management (QRM) has been recently approved by the ICH Management Committee (1). ICH Q9 is a key document associated with change management and validation. The original ICH Q9 was issued more than 10 years ago. Relevant documents associated with the approved revision project are linked below. This topic was...
Tim Sandle
The use of medical and pharmaceutical cannabis is extending worldwide. For a long period in history humans have made use of the Cannabis plant in the form of hemp, which was traditionally used in textile and fiber-based applications. In addition, the flowers of the Cannabis plant have been smoked for different properties. It is in the past one...
Tim Sandle
As the use of medicinal cannabis becomes more widespread (and in parallel, recreational cannabis),together with several examples of cannabis-based pharmaceutical products in development, the quality aspects (safety and efficacy) that would apply to any healthcare or pharmaceutical product need to be rigorously applied (1). This article, which...
Karen R. Zimm and Renee King-Alliego
A comparison of post approval variation types is explored providing an introductory understanding of RA terminology associated with variations or post approval submissions. The term variation is typically associated with the European Union and Rest of the World countries while post approval submissions is a more accepted term within the United...
Paul L. Pluta
This paper continues a series of discussions addressing the application of validation principles to the training quality system. Validation Lifecycle Stage 3 Continued Process Verification is applied to the training quality system. Training monitoring activities ensuring the ongoing consistent performance of trained procedures are proposed....
Martin J. Lipa, Kevin O'Donnell, and Anne Greene
This particular study represents novel thinking around the concepts of Knowledge Management (KM) and Quality Risk Management (QRM) practices, both as they relate to each other, as well as the regulatory governance on which life science organizations rely. Further, this paper is relevant to the ongoing revision of ICH Q9, Quality Risk Management,...
Jeanne Moldenhauer
Natural disasters, now including pandemics, have had - and will continue to have - a major impact on the pharmaceutical, biotechnology and medical device industry. Many companies will be struggling to determine how to bring their facilities back online following months of shut-down or skeleton crews. This paper, originally published...
Tim Sandle
Electronic cigarettes and vaping products containing nicotine are showing ever increasing sales, since their debut in the USA in 2007. From one perspective, such products can provide a stepping stone for coming off traditional cigarettes and hence towards improved health outcomes; from another perspective, some people are taking up vaping having...
Bernard Hsu
,
Paul L. Pluta
A recent news story describing loss of life caused by excessive consumption of licorice candy has been widely reported (1-3). This story involved a highly unlikely and unexpected cause of death - eating candy! This event is a reminder of several similar pharmaceutical occurrences -- serious unexpected consequences involving the content of drug...
Eric Kastango
,
Kevin Hansen
Compounding Pharmacists have a very challenging, and rewarding job, in their development of specialized medicines for individualized patient care. For many, there is satisfaction in working to solve the needs of patients through innovative partnership with patient and practitioner. Too often professionals in this space are mired by regulatory...
Richard Forsyth
Cleaning validation is critical to the pharmaceutical industry, ensuring that risks of contamination, product carry over, and cross contamination are controlled, minimized, and monitored to maintain patient safety and product quality. In this episode of Voices in Validation we discuss the lifecycle approach to cleaning validation, and the...
Christopher Flask
,
Lorianne Richter
,
Nuala Calnan
On this episode we go back to basics and get some facts straight. All processes and products come with some level of inherent risk. In life sciences, the goal is always to reduce risk as much as possible ensuring patient safety to the maximum extent. This systematic process for the assessment, controls, communication, and review of risks across...
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