User Requirement Specification

What is User Requirement Specification?

URS is abbreviation for “User requirement specification” in pharmaceutical manufacturing, before procurement of any machine or commissioning of any department area, clean room or any equipment, Each and every requirement of the department area clean room or equipment is mentioned in clear details, in a document, this document after listing down the requirements becomes more like specification cum requirements which are demanded from manufacturer or supplier or contractors, engineering firm which is going to provide the service.

For an example for a machine to be designed the following will be URS.

 URS for Manufacturing vessels.

1. Equipment: Manufacturing vessel.
2. Capacity: 5000 liters. Facility to know the amount of product.
3. Material of Construction: SS 316 L
4. The joints in the inner surface: must be smooth, electro polished.
5. Thickness of body: 8 M OR 10 MM
6. Clean in place system should be provided.
7. PLC panel: Equipped with three level password facility, compliant with 21 CFR part 11, computer system.
8. Make of panel:
9. Motors:      HP, Make:
10. Safety features:
11. Equipped with bottom mounted load cells: Make: Mitsubishi.

One should give every minute detail requirement in the URS, which affects the quality and performance of the equipment, one may specify specific manufacturer for parts like motors, gears, switches, and panel, thickness of galvanized sheet of the panels being used, the smooth finish or the panel, Colour shade number.

URS must be practically feasible and add value to the design and quality of the equipment.

How to prepare an User Requirement Specification?

It is required to define the use of the equipment or clean room or department, of who’s URS is to be prepared.

The important requirements are based on the business requirements, like capacity and speed, etc.

Then comes the requirements of quality features, and special design requirements, these are required to be developed after input from every team member like production, engineering, and quality assurance, Business.

All the suggestions are listed and priority wise they are included in User requirement specification, URS is required to be signed by the head of the unit, and quality assurance head and business heads for the commercial part.

After this activity, User requirement specification became a part of the quality assurance system. Every URS has a unique number generated by QA dept.