The Journal of GXP Compliance
Vol. 23, Issue 6, Nov 2019

Tim Sandle
This article outlines the Riboprinting technology and discusses some applications of the approach, which can assist within investigations within the pharmaceutical context.
Georgina Rodriguez and Zara Munir
This article provides guidance on GMP considerations that must be made when conducting trimming, drying, and curing processes for cannabis production, as well as providing highlights to operational constraints and hurdles when adopting GMP.
Paul L. Pluta, Jenna Crosby, Michaela Murphy and Alan M. Mancini
Medication errors involving drug names are a significant concern in healthcare practice. Drug name errors may occur with the printed word, spoken word, and or be caused by electronic systems. User practices such as shortening drug names, illegible handwriting, and other negligent actions contribute to drug name problems. Drug name errors are a...
Lorianne Richter; Anne Greene
This article represents the second, in a three-part series on overall effectiveness of the pharmaceutical CGMP training program. This second article focuses on how various training modalities discussed in the first article are fulfilling adult learning needs or creating shortcomings in the adult learning experiences, which likely result in a less...
Emma Ramnarine, Anders Vinther, Anne Greene, and Kevin O'Donnell
Product quality and patient safety have been foundational and at the core of pharmaceutical regulations and operations for decades. The history of quality management can be traced back to the Middle Ages, where the focus was for a finished product to meet all quality standards ensuring customer satisfaction. This article explores the evolution of...
Paul L. Pluta, Jenna Crosby, Michaela Murphy and Alan M. Mancini
There are several primary categories of drug names. Each drug name category has different objectives, requires significantly different activities supporting its proposed name, and is approved by a different regulatory agency. This discussion provides a brief overview of the respective categories of drug names and how these names become approved...
Jeanne Moldenhauer
While there is no clear regulatory guidance that describes or provides a certification for GMP-equipment, this article reviews the GMP requirements as identified by searching the 21 CFR 211 Keyword Index.
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