The Journal of Validation Technology
Vol. 27, Issue 2, Apr 2021

Tim Sandle
Control of pharmaceutical water systems represents an essential part of Good Manufacturing Practice and embedded within this is the quality control testing of water systems for viable microorganisms, and subjecting the data obtained to trend analysis. This has traditionally been achieved by membrane filtration and the use of a culture medium....
Paul L. Pluta
Discussion of non-technical management topics is always an area of interest in validation and QA professional meetings. Validation and QA employee job satisfaction topics were addressed in multiple sessions with pharma industry managers during the IVT Validation Week in 2019.  Specific ideas to enhance employee satisfaction in the GMP...
Paul L. Pluta
Managers have also described problems that have negatively impacted PQ documents, problems not with validation PQ documents per se, but associated problems affecting PQ documents. These events damaged PQ credibility, and sometimes necessitated repetition of a previously completed validation. These experiences demonstrate the need for proactive...
Jeanne Moldenhauer
Since the beginning of the Covid-19 pandemic, business life has changed. There is a reluctance to travel. Companies are reluctant to have visitors on site. There has been a significant increase in employees working from home have also been increases in having meetings held virtually. This has resulted in a significant reduction in company audits...
Jeanne Moldenhauer
,
Paul L. Pluta
,
Stacey L. Bruzzese
The idea for Audit Forum came from multiple sources. Validation and Quality Managers have often requested that audits topics be addressed in the IVT journals; there is universal agreement among industry personnel for the need to address topics related to audits. Regulatory agencies have been forefront in audit practice changes.
Yeleiny Machín, Yeosvany Cabrera, José Miguel Fernández, Ricardo Pina, Yoel Pérez, Onel Valdivia, María T. Barceló, Lisbet Ulloa, Liudmila Benítez, Ronny Camacho, Duniesky Martínez, Enrique R. Pérez
In this paper we describe the development and validation of a sandwich-type Enzyme-Linked-Immunosorbent Assay (ELISA) assay based on a sheep polyclonal antibody developed to determine porcine immunoglobulin G (IgG) concentration in serum samples. The coating and blocking conditions were established. The immunoassay demonstrated the ability to...
Jeremy M. Ebersole
Statistics Roundtable is a new IVT feature that will provide readers an opportunity to discuss information about statistics and demonstrate the application of statistics to pharmaceutical problems. The use of statistics is fundamental in regulated industries. The statistical basis for decision-making is an expectation. Any effort to increase the...
Tim Sandle
This post is the first in a series of three articles looking at the Digital Data, from online papers and surveys, to text messages and interactive voice response systems, which we compile and use in research. This article looks at some examples of how data can best be stored, archived, indexed, and presented. Here the goals of digital archiving...
Tim Sandle
Digital research is essential for the modern pharmaceutical or healthcare facility, and this requires the process of undertaking digital searches. This can include specialist software, such as regularly updated pipeline databases to searching specialty journals, or utilizing different online database to obtain data. The search and research process...
Tim Sandle
This blog post is the last in our 3-part series on Digital Data. Here we will discuss data governance, incorporating data governance policies into your corporate SOPs, data ethics, cyber security, digital data management techniques for pharmaceutical and records management.
Kaiser Jay Aziz
This publication addresses biosimilar biologic drugs development and future innovations. Emphasis is placed on quality system approaches to the development and availability of new biosimilar drug products presented in premarket applications. For approvals of new biosimilars, the sponsors of premarket applications must present analytical and...
Kaiser Jay Aziz
Principles of Genome Editing can be applied in the various areas of medical diagnosis and treatments - from early process design/development through maintenance of the validated state during commercial manufacturing and post-marketing surveillance. Gene editing and clinical applications comprises of systematically assessing, monitoring, and...
Igor Gorsky
In this episode of Voices in Validation we highlight topics covered in a recently published book, Principles of Parenteral Solution Validation, A Practical Lifecycle Approach, which has also recently been reviewed in the Journal of Validation Technology. Included in the discussion are the unique points of process validation in parenteral solutions...
Lorianne Richter
,
Nuala Calnan
,
Randy Friedman
This week our series coordinators, Lori and Nuala, continue their discussion with guest Randy Friedman. More to come in this lively discussion on the ways in which bias and heuristics impact risk management, risk identification and the decisions made during the process. Plus hear how to coach people to be stewards of knowledge, tactics for...
Ivan Soto
Managing change is a routine part of doing business in the pharma and biotech industries. Utilizing a risk-based lifecycle approach to manufacturing allows us to identify, analyze, understand, manage and report any risk, or potential risk throughout the lifecycle. When it comes to change control, it can be much more challenging to apply risk-based...
Karen Ginsbury
We welcome guest, Karen Ginsbury for a lively discussion on Quality Management System, the progression of regulatory guidance and expectations, whether or not they are helping or hindering the process, and how we can move forward with risk-based critical thinking in QMS.
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