JVT Journal Articles
Vol. 16, Issue 3, Sep 2010

The following key points are discussed: A case study involving process validation of a batch size increase for a liquid solution product is described. The batch size increase was considered to be a relatively simple change because other similar products at the site were already manufactured at the same increased batch size, and the equipment...
Kevin O’Donnell, Ph.D., is Market Compliance Manager at the Irish Medicines Board (IMB) in Dublin, Ireland. He is responsible for a number of compliance-related and market-surveillance programs at IMB, such as the quality defect and recall program and the sampling and analysis market surveillance activities. Kevin is active at a European level in...
The following key points are discussed in this article: The principle of reverse osmosis (RO) involves the flow of water containing ions through a semi-permeable membrane using pressure as a driving force to significantly reduce the ion concentration as well as other undesirable materials. The system array, membrane configuration, and membrane...
Parametric release is based on the principle of controlling critical process parameters (CPPs) within their respective acceptable ranges (i.e., within the established control space of the process). The CPPs and their acceptable ranges are developed during characterization phase (1). The goal of the characterization studies is to demonstrate that...
The following key points are discussed in this article: Benefits, drawbacks, and concerns of developing software code in-house versus outside contractors are discussed Main objectives of vendor management for software development are discussed Types of vendor audits and their appropriate use are described Audit preparation is a key component...
The following key points are discussed: Smoke studies, or airflow visualization tests, are a key activity in the qualification, maintenance, and monitoring of an aseptic facility Discussions of the specific methods and techniques to conduct and record airflow visualization are not readily available Basic airflow characteristics for the...
The following key points are discussed: Medical device companies must by law meet certain US Food and Drug Administration requirements before marketing a new or substantially modified (physically or in labeled/intended use) device in the US. Devices are generally defined. Devices may include associated components and software. Devices are...
The following key points are discussed: Quality by design can be traced to the original work of Dr. Joseph M. Juran. Juran believed that nearly all problems (e.g., deviations, quality defects, etc.) are built into the system, and that they can be traced to inadequate design of the process. Therefore, if addressed during the design phase, they...
The following key points are discussed: The most probable number (MPN) method is useful for estimating quantitative bioburden if plating for colony forming units is not advised. This method is described in United States Pharmacopeia chapter <61> and by the US Food and Drug Administration in the Bacteriological Analytical Manual. Details...
The following was the subject of a lunchtime discussion at the Institute of Validation Technology’s Validation Week Europe in Dublin in March 2010. Participants discussed various problems they had experienced in the daily performance of validation at their respective sites. Documentation quality was a major issue. The following discusses one of...

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