The Journal of Validation Technology
Vol. 28, Issue 1, Feb 2022

Tim Sandle
Mycoplasmas can alter infected cells at the molecular level and trigger visible changes in cell morphology and growth characteristics. Cell lines are of great importance of biopharmaceutical manufacturing and research, and they are required for many of the new generation of Advanced Therapy Medicinal Products (ATMPs). This review paper looks at...
Paul L. Pluta
Pharma industry designs all aspects of products; product design, primary containers, packaging, labeling, coloration, dosage regimens, supporting information, product training and other activities. If pharma personnel who are involved with product design activities can understand medication safety concerns with products in actual use, proactive...
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...
Alan M Golden
In this follow-on article we will discuss why statistics are important in validation, and the regulatory requirements for statistics in our processes. The proper use and application of basic statistics allows the window into our process, so appropriate determinations and decisions can be made. Also, the proper use of statistics allow proof that...
Paul L. Pluta
The validation of cleaning processes is an important requirement in pharmaceutical manufacturing. Cleaning process validation assures product integrity, i.e., there is no contamination of product with drug residue from prior manufacturing. After completion of a cleaning procedure, processes are validated by sampling cleaned equipment at specified...
Aymé Oliva-Cárdenas, Milagros Vargas-Hernández, Yamila Martínez-Cuéllar, Yusmel Sordo-Puga, María Rodríguez-Moltó, Carlos A. Duarte, Mary Méndez-Orta, Elaine Santana-Rodríguez, Talia Sardina-González, Alianne Fundora-Llera, Danny Pérez, Marisela F. Suárez
This article reviews the standardization of a potency test in mice for Porvac, a novel subunit vaccine against Classical Swine Fever virus as a candidate to substitute the current viral challenge test in pigs in the batch to batch release of vaccine lots. Some studies such as linearity, parallelism, specificity, and intermediate precision are also...
Paul L. Pluta
Recent news stories from the United Kingdom (1-3) reported a fatal event related to COVID – not involving viral infection but related to wearing the COVID mask. The COVID face mask contributed to a patient cause of death – note contributed terminology. This error represents an application of Look Alike-Sound Alike (LASA) medication errors – a LASA...
Karen Ginsbury
This week we share a presentation from Karen Ginsbury. Listen in as she shares her ideas on data integrity lapses, and demonstrates how automating now can save your business in the future. Karen looks at how the pharmaceutical industry and even society misunderstand what integration truly is. Karen also provides insight on how the industry can...
Kate Coleman
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Nuala Calnan
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Valerie Mulholland
This week on Voices in Validation, Risk Revolution series coordinator Nuala Calnan and regular contributor Valerie Mulholland discuss the ICH Q9 Revision with Kate Coleman of PharmaLex. The the ICH Q9 revisions were released for public consultation in November and are an improvement over the existing guidance but do leave a few areas that need to...
Brian K. Nunnally
COVID has changed nearly every facet of society, and many of the changes will be permanent, not returning to the “old ways.” While we often take comfort in the status quo, this pandemic has allowed us many positives too, including better digital capabilities, and a better understanding of technological implications on drug development. New...
Justin Bechtel
This seems to be the era of the great resignation. Now more than ever in recent history employees have the advantage, and this is true across regulated industries as well. Unfortunately, the amount of training and experience necessary in maintaining GMP standards, delivering quality products, and patient-first service, means this can be an...
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