The Journal of Validation Technology
Vol. 26, Issue 1, Feb 2020

Jeanne Moldenhauer
Mold is s common contaminant in many different places including pharmaceutical facilities, buildings, homes, food, agriculture, and many other locations. Molds are ubiquitous in nature. A number of health issues are known to be related to the presence of mold. These issues range from running noses to life-threatening conditions. The so-called Sick...
Natasa Vukicevic, Aneta Dimitovska, and Jelena Acevska
Pharmaceuticals are essential for human and animal health. At the same time pollution of waters and soils from pharmaceutical residues is an emerging environmental problem as well as an emerging public health concern. These are sometimes persistent and harmful for the environment. In order to protect the waters and soils in their functions as...
Alma O'Reilly and Donncadh Nagle
Change Management is one of the cornerstones of a Pharmaceutical Quality System (PQS) and is a key fundamental for maintaining its effectiveness. However, poorly planned or executed equipment changes to validated systems can pose a risk to product quality, patient safety, and business. In particular, when the change is classified as Like-for-Like...
Allan Marinelli
Many organizations within the pharmaceutical, biopharmaceutical, medical devices, and vaccine industries have procedures, work instructions, job aids or other methods describing activities within in their respective departments. QA (Quality Assurance), IT (Information Technology), CSV (Computer System Validation), and other departments function...
Paul L. Pluta
This discussion is part of the ongoing PQ Forum series and addresses the use of words and phrases commonly used in spoken language that should not be used in technical validation documents. Words and phrases including overly complicated or uncommon words, phrases with too many words, duplicate words, and clichés and slang. These are commonly used...
David L. Jones
Edwin van den Heuvel
Niloufar Parsaei
The current EP 5.1.66 chapter has more clearly defined the requirement for suppliers of Rapid Microbial Methods (RMM) to supply the formal validation data obtained using their method. The analytical testing is well defined in the chapter however the statistical analysis is not as clear. The USP has made a clear choice to focus on equivalence or...
Tim Sandle
Vapor phase hydrogen peroxide cycle qualifications use endospores of the microorganism Geobacillus stearothermophilus as biological indicators. The requirement of the biological indicator is to demonstrate adequate sanitization of the isolator through achieving a six-log10 reduction. There are alternatives to endospore biological indicators, such...
Lorianne Richter
Nuala Calnan
This article represents the third, in a three-part series which considers the overall effectiveness of pharmaceutical CGMP training programs. This article will focus on encompassing adult learning theory into the process of designing and delivering effective CGMP training programs and how organizations can mature beyond the training environment...
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