JVT Journal Articles
Vol. 16, Issue 2, Jun 2010

The economic problems the world is currently facing have caused severe cost pressure on pharmaceutical manufacturing. Revalidation of manufacturing processes and equipment comprises a significant cost to the industry. Maintaining a validated status is a regulatory requirement. Technical issues, patient risk, and business considerations impact the organizational approach to revalidation. This discussion addresses the...
The following key points are discussed in this article: Design of experiments (DOE) consists of three basic stages: screening (to identify important factors), response surface methodology (to define the optimal space), and model validation (to confirm predictions A critical preliminary step in the screening stage is for subject matter experts...
The following key points are discussed in this article: There is no trade-off between quality, productivity (quantity), and compliance Some simple statistical concepts demonstrate that only operations that successfully reduce variation and improve quality will achieve high output, low work in progress, and good compliance There are several...
This issue of the “Device Validation Forum” discusses the issues and considerations for successful verification and validation (V&V) of a new or substantially changed medical device. Product validation is different from process, equipment, or software validation, although any or all may be involved in a product’s development and included in a...
The following key points are discussed in this article: Pretreatment components are unit operations employed prior to removal of ionic material. Primary types of pretreatment units include multimedia filtration, activated carbon units, and water softening units Multimedia filtration removes particulate matter from raw water by passing raw...
The following key points are discussed in this article: The number of sites to be used in qualifying clean rooms for non-viable particulate measurements can be found in International Organization for Standardization (ISO) 14644-1. However, there are no recognized standards for determination of this number for viable air (passive and active)...
Kevin O’Donnell, Ph.D., is Market Compliance Manager and a Senior GMP Inspector at the Irish Medicines Board (IMB), in Dublin, Ireland. He is responsible for a number of compliance-related and market-surveillance programs at the IMB, such as IMB’s quality defect and recall program and its sampling and analysis market surveillance activities....
The following key points are discussed in this article: The US Food and Drug Administration’s 2008 draft guidance on process validation provides clear statements on the need for statistical procedures in process validation Statistical applications should be used throughout the entire product lifecycle— development through ongoing...
The following key points are discussed in this article: Mechanical property is the relationship between applied force and the resulting deformation of a material Stress and strain are the basic descriptors of the applied force and deformation in the characterization of mechanical property Deformation may be categorized as elastic, plastic, or...

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