JVT Journal Articles
Vol. 14, Issue 2, May 2008

Cleaning validation is often viewed as a regulatory necessity that can be put off until the last minute. This “quality-by-chance” approach can lead to some adverse consequences, especially during a new product launch where a single day’s delay can cost millions. Such consequences can be prevented if validation is performed after the cleaning process is demonstrated to be robust.
In the pharmaceutical and biotech industries, companies are often required to modify an existing facility or build an entirely new facility. These modifications and expansions are done to support the launch of a new product, increase production of a current product, or to add an additional product line using the same or similar equipment used to...
One of the widely recognized references on process validation with regard to sampling and testing plans is the US Food and Drug Administration’s Draft Guidance for Industry: Powder Blends and Finished Dosage Units—Stratified In-Process Dosage Unit Sampling and Assessment (1) that is based on the Product Quality Research Institute (PQRI)’s...
Michael H. Anisfeld
FDA’s mission statement states in part that FDA’s purpose is “protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation (1).” This mission is performed in two parts: first the scientific...
The number of instruments and devices on the periphery of processing systems can easily number in the thousands. As a result, it is important to implement a naming convention for these instruments and devices that follows a logical sequence for ease of system management and development. In process-driven industries, instruments such as controllers...
There has been significant effort to define expectations of regulators regarding scientific information on formulation and process development to be filed in submissions.
This installment of “Statistical Viewpoint” presents eight example scenarios that demonstrate how a probability approach can help with resource planning and decision-making. All examples utilize various discrete or continuous probability distribution calculations available in Microsoft (MS) Excel. This program is readily available and provides an...

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