The Journal of Validation Technology
Vol. 22, Issue 5, Oct 2016

William V. Collentro
The following key points are discussed: Basic theory of distillation and types of distillation units utilized for production of water for injection (WFI) are discussed Distillation is a process that employs a phase change for water (liquid) to water (gas or steam) A distillation unit employs three sections: evaporator, a vapor-liquid...
Ronald D. Snee
Consider the following scenario, a new pharmaceutical or biotech scientist or engineer is assigned the job of solving a problem, improving a process, or just developing better understanding how a process works. Five different people are asked for advice and guidance, and five different recommendations are received and summarized as – quality by...
Patricia L. Smith
Recognition of sampling errors and their impact on data variation is an important consideration in pharmaceutical and medical device validation. The evaluation of suspect data may be enhanced by consideration of sampling errors. Validation and compliance professionals must always be aware of the potential for sampling errors and their impact.
Bernard McGarvey
Brian K. Nunnally
John McConnell
Over-control is a common and serious problem in many industries, including the pharmaceutical and biotechnology industry. It is found throughout organizations including in laboratories and manufacturing units. It is found anywhere where adjustments can be made based on data. Over-control is a problem because it always increases the variability of...
Kevin O’Donnell
The past ten years since the finalisation of ICH Q9 have seen significant efforts by industry and regulators to increase use of risk-based approaches in pharmaceutical applications. The GMPs, in particular, have undergone very significant changes to reflect the concepts of QRM, both in the US and EU. Despite these efforts, the question...
John Hyde
Andrew Hyde
Paul L. Pluta
FDA issued Process Validation: General Principles and Practices in January 2011. The guidance integrates strategy and approaches to provide a comprehensive approach to validation. Three stages in the lifecycle approach are identified. The lifecycle concept links development, validation performance, and product/process maintenance in a state of...
Paul L. Pluta
This case study describes a cleaning validation event in which failing results for API residue from a small molecule extended release tablet dosage form were observed. The initial two lots in the cleaning validation were successful. The third lot failed acceptable residue limits. Investigation of the failure comprised cleaning process development...
Kelly Waldron
This paper offers practical advice on how to improve the risk analysis portion of the QRM lifecycle, with particular attention paid to the typical ordinal risk rating scales that are used during risk analysis. Rating scales are criticality important in the risk process. A wealth of academic and industry literature exists that imply that rating...
Alexander Delli Paoli, Jr.
The following key points are discussed: Understand the reason your site needs different types of HVAC systems Recognize all the HVAC components and their purpose Understand how all the components interact Be aware of the physics of air: Psychrometrics Assure proper safety measures are in place A system is only as good as its maintenance...
Gregory P. Martin
Vivian A. Gray
The following key points are discussed: Validation of analytical methods in the pharmaceutical industry is a well-known requirement of current good manufacturing practices, and dissolution methods fall under this requirement. The validation exercise for dissolution methods addresses key areas including product performance reproducibility,...
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