User Requirement Specification (URS) of Equipments : Pharmaguideline

Online GMP Courses with Certificate


User Requirement Specification (URS) of Equipments

Preparation of user requirement specification of equipments and instrument used in pharmaceutical manufacturing and quality control.
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:
User Requirement Specification Preparation2.1 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. Operational Requirements:
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.

5. Abbreviations: List all abbreviations used in this user requirement specification document.

6. References: Write the title of reference books or guidelines.

7. Approval:

Name & Designation
Prepared By

Checked By

Approved By

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question

4 comments: Post Yours! Read Comment Policy ▼

  1. Hi. Who is responsible to provide final approval URS (example for ourchase new equipment). Is it QA or equipment owner or a few departments eg Equipment owner, QA and engineering ?

    1. 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.

    2. Thank you for the feedback Mr Devidas

  2. Who is responsible to approve URS ? System /equipment owner or QA or to be jointly approved ?


Please don't spam. Comments having links would not be published.

Popular Categories

QA SOPs QC SOPs Micro SOPs HVAC Production SOPs Stores SOPs Checklists Maintenance SOPs HPLC Sterile GLP Validation Protocols Water System GDP Regulatory Maintenance Calibration Warning Letters Education B.Pharmacy
Online Courses

Follow Pharmaguideline



Editable Pharmaceutical Documents in MS-Word Format. Ready to use SOPs, Protocols, Master Plans, Manuals and more...



Recent Posts