User Requirement Specification (URS) is a list of all requirements of buyer regarding the equipment to be purchased. URS is prepared by the equipment user department. It is sent to equipment manufacturer to make it as desired criteria.
Following points should be included in a pharmaceutical user requirement specification.
1. Introduction: A brief introduction of the equipment should be written.
2. Overview:
2.1 Intended Use: Write the use of the equipment in the manufacturing.
2.2 Capacity: Write the required capacity if the equipment in the liter or kgs.
2.3 Space Availability: Write the available space for installation of the equipment including height, width and height in mm.
2.4 Accuracy of Instrument: Write the desired accuracy of the instrument in decimal places if applicable.
2.5 Cleaning Requirements: Instrument should easy to clean. Write, if there is any specific cleaning requirement.
2.6 Equipment Specific Requirements:
2.6.1 Required quality of Stainless Steel (SS) as SS-308, SS-316 or SS-316L if applicable.
2.6.2 Write the specific requirements of the instrument as number of baffles and revolutions per minute (RPM) in Blender and requirement of fix lid and hand wheel in Paste Kettle.
3.1 Functional Requirements: Specify all technical requirements for the equipment.
3.1.1 Operation: Write the operational requirements.
3.1.2 Control System: Specify ON, OFF or other specific equipment control requirements.
3.1.3 Power: Write the requirements on power failure as autostart or manual.
3.1.4 Safety: Write the requirements of safety guard and MCB trips on short circuit or overload
3.2 Environment: Temperature and humidity of the area where the equipment will be installed.
3.3 Other Requirements: Write the other requirements as the metal of construction (MOC) of non-contact parts and specific requirements of seals and tubing.
4. Compatibility and Support:
4.1 Utilities: Available power supply on which instrument shall be operated. The requirement of the uninterrupted power supply (UPS) and other specific utility requirements.
4.2 Availability: Continuous operating time of the equipment in hours or working shifts.
4.3 Supporting Documents: Requirements of operating manual, circuit diagrams, warranty letter, change part list, spare part list etc.
6. References: Write the title of reference books or guidelines.
7. Approval:
Name & Designation
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Department
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Signature
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Date
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Prepared By
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Checked By
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Approved By
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Related: Download Sample URS
Responsibility as per expert including equipment owner should write URS,put addition input of engineering point of view and again QA shall review for compliances as per regulatory requirements.
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