Facilities Utilities and Equipment

In preparation of IVT's Validation Week, Paul Pluta, Ph.D., during his "Validation Essentials Webinar," explained the lifecycle approach to process validation as it applies to equipment qualification. The beauty of equipment qualification, Dr.


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Commissioning and qualification of facilities, utilities, and equipment in a manufacturing environment is a multi-team and...
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Facility, utility, and equipment qualification is a complex process with multiple stakeholders. It is no surprise, therefore,...
For commissioning and qualification of facilities, utilities, and equipment (F/U/E), a quality risk management approach can be...Download
Special Edition
This special edition focuses on the current and important aspects of facility validation and qualification. Topics include,...Download
Within the complex facilities, utilities, and equipment (F/E/U) in a manufacturing plant, a line in the sand needs to be drawn between GMP-critical and business-critical. While the process for identification has been discussed before, the following are the differences between a GMP-critical and business-critical F/E/U, including the respective change management, taken from a Jorge Cordero...
Change Control is the implementation of, and adherence to, a formal process that documents any change to a (specified/qualified/validated/approved) piece of equipment, system, process or document that can affect the identity, strength, quality or purity of a drug product.
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, valves, sensors, and switches are often...
This discussion addresses the physical properties of air and water vapor mixtures. The components of the heating, ventilation, and air conditioning (HVAC) process that alter the moisture content of air to achieve desired levels in the facility or manufacturing process being served are described. Topics discussed can be thought of as the “wet side” of HVAC. The wet side includes all aspects of...
In recent years, several guidances and standards have been written and published on the topics of commissioning, qualification, and validation. Some of these guidance documents provide ideas for efficiency and cost saving. One of the key aspects of efficiency is the integration of commissioning and qualification activities. Additional concepts and ideas have been discussed at a number of...
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