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Utilities Business Review | Monday, February 06, 2023
In the pharmaceutical industry, most people generally understand change control for equipment and facilities, but they lack the knowledge needed to apply this control to highly sophisticated equipment and utilities.
FREMONT, CA: Many companies handle equipment and facility change control separately, if at all, by limiting change control to documentation such as batch records, standard operating procedures, protocols, and specifications. It is common for new equipment to be installed and connected to utilities without the involvement and approval of facilities, engineering, validation, and quality staff.
Most pharmaceutical professionals understand the concept of change control regarding basic equipment and facilities. However, they lack the knowledge to apply it to highly sophisticated equipment and utilities.
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Determining the new equipment's utility and IT requirements: Identifying the utility and IT requirements for the new equipment is a key step in equipment change control (ECC). Before purchasing equipment, companies must detail the equipment's utility requirements. If utilities are upgraded, and other equipment purchases are required to ensure proper operation, the cost of purchasing the equipment can often double.
Assessing the new equipment's impact on utility validations: Analyze whether installing new equipment will affect previously executed utility validations once you have determined the existing utility capacity and compared it with the requirements of the new equipment. It is necessary to update the drawings, schematics, and materials of construction detailed in the utility's installation qualification (IQ) if the installation and functionality of new equipment require adding new utility points of use (POU) to connect the equipment to the utility. The POU will receive new piping and instrumentation diagram numbers. This change will likely require revising the operational qualification (OQ) to ensure the new POU is functional, and for gas systems, a pressure-hold challenge is important.
Equipment installation and calibration and validation: The calibration of equipment should match or exceed the intended operating range of the equipment used during production activities. Most equipment is operated outside its calibrated range regarding rpm, flow rate, and compression force. An audit observation like this is common during sponsor and regulatory inspections.
Validation master plans (VMP) outline the quality requirements for the types of equipment already in-house and outline the validation requirements. Defining the scope of the VMP includes defining the systems, equipment, methods, and facilities, the validation compliance requirements, including how the validated state will remain, and the validation risk-mitigation strategy.
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