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JETT seeking input on User Requirement Specifications

Two current projects include revising URSs to a new tablular format and developing URSs for serialization.
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Founded more than 10 years ago, JETT (Joint Equipment Transition Team) is a consortium of healthcare industry equipment users, equipment suppliers, and consultants seeking to improve communications between users and suppliers to more effectively meet the validation requirements of the industry. Equipment that is considered includes machinery used in processing, primary packaging, secondary packaging, and labeling.

With active members from companies including Genentech, Abbott Laboratories, CQS Innovation, Rockwell Automation, and MGS Machine, JETT’s goals are to:

1. Provide a common technical language base, bid [on] package formats, and [develop] validation test plan examples that will be widely accepted by the industry.
2. Promote communications between equipment users and suppliers.
3. Streamline time-to-market projects by incorporating GAMP (Good Automated Manufacturing Practice) guidelines and validation requirements up front in major projects.

To help the industry, JETT offers numerous tools that can be downloaded free of charge from the “Sample Documents” section of the Web site.

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JETT team members currently are focusing on two major projects:

1. Revising all current URSs (User Requirement Specification) to the new tabular format. The new tabular format concentrates on the identification of “quality critical requirements” by placing the requirements in a numbered table. Items that are business, operational, or optional are also delineated. This same numbering system can follow through the Functional Specification, FAT (Factory Acceptance Testing) protocol and IQ/OQ documents. The numbering system and documents are controlled through a traceability matrix.

According to GAMP5, “User Requirement Specification (URS) defines, clearly and precisely, what the regulated company (pharma) requires the system to do. It is the responsibility of the regulated company but may be written by a third party.”

This format helps clarify requirements to suppliers and eases tracing these requirements through functional specifications, design specifications, FAT protocols, and validation.

2. Developing a series of URSs that include equipment and control systems for serialization and/or track-and-trace operations.

JETT, part of GAMP Americas Community of Practice within the Intl. Society for Pharmaceutical Engineering (ISPE), is actively recruiting industry assistance in developing these industry-shared documents. If you are interested in a helping with these projects, please contact Jim John at [email protected] or mel.bahr@mgsmachine.com.

Edited from an article supplied by Mel Bahr, MGS Machine

 

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