URS - User Requirement Specifications

Hello Readers........ Good Day!!
Back after a short gap, Received many mails asking to give a brief on URS......!! And i'm ready to present you with my knowledge regarding URS, this term is most common in projects department, and also an engineer who want to survive in a pharma industry should be knowing something on this topic, as at some point of time one should face it, not even at some point, but this is becoming a hot topic when some one conducts an interview, its like a heart of an equipment, every equipment will have an URS document.

What is URS ?

URS refers to User Requirement Specifications

Given a comprehensive User Requirements Specification that has been approved by QA and is under project change management, the Design Qualification (DQ) process then can be reduced to two key objectives:

• Documented verification that the overall design appears to address, by some means, each and every requirement; in the URS, affecting the product and performance of the manufacturing process (or, in the case of unknown product or multi-product manufacturing facility, the required equipment/ system performance capabilities).
• Identification (and documentation) of the critical individual physical components, attributes, and operational features that directly support meeting each requirement.

This is the Technical definition of URS, and now i'll simplify it, URS is nothing but just specifying a list of categorised requirements in a document that stands as a surety as the equipment will perform upto the mark.

So, Basically there will be seven categories in a URS document,

1. Process / Product Requirement,
2. Operational Requirement,
3. GMP Requirements,
4. Safety Requirements,
5. Document Requirements,
6. Discussion / Review / Comments,
7. URS Approval.

Now, i'll explain you briefly what comes under these categories briefly,

1. Process / Product Requirement: This includes the basic things like,

Name of the Equipment, Purpose of the Equipment, Number of Such Equipments Required, Capacity and model of Equipment, Any other Specific requirement, Chemical / physical / characteristics of the materials to be handled in the equipment, Process Description and Schematic diagram of the equipment.

Now i'll discuss with an example, i've need a  GLR and now i'm gonna prepare one Process/Product requirement Column for GLR, now see.

Name of the Equipment: Mild Steel Glass Lined Reactor,

Purpose of Equipment: To handle Reaction and Extractions,

Number of Equipments: one [ it depends],

Capacity and Model of equipment: 3 KL capacity with 2 impellers [propeller],

Chemical/Physical characteristics of materials: Refer to the  Process,

Process Description and Schematic Diagram: Refer to PFD & P and ID,

That's it..........!!!
Now,

2. Operational Requirements: This includes the following things,

Production stage, Desirable way of charging the input, Desirable method of unloading, Preferable method of cleaning, Required Utilities, Any other Specific Requirement, Batch Size/Lot size, Number of operational hours, Process Control Requirements, Desired level of instrumentation, Change Over Parts Requirement.

For the same GLR as example, see now,

Production Stage: Product - 2

Desirable way of charging input: HDPE Hooper,

Desirable way of unloading: Through Vacuum suction,

Preferable method of cleaning: Rinsing,

Required Utilities: Power, Brine, RT, Steam, Chilled water, Hot water, Nitrogen, Air.

Any other Specific Requirement: Motor should be flame-proof,

Batch size: 200Kgs,

Number of hours operations: 16 hrs,

Process Control Requirements: Pressure gauge, Vacuum gauge, RD, SRV, TRV.

Desired level of instrumentation: Bottom valve operation based of HMI protocol,

Change over parts Requirements: NA.

That's it......Cheers,

3. GMP Requirements: Have a look below,

MOC specification, Working area environmental requirement, Desired means of avoiding contamination or Cross-Contamination, Any other Specific GMP requirement.

For the same GLR, the GMP requirements will be like,

MOC Specification : The Equipment design should be done based on process, environment and operator safety, the equipment shall have the facility to clean the contact parts or non-contact parts, the surface of equipment should not be reactive.

Working area environmental requirement: The area should have good lightening facility for operations as well as for performing cleaning activities,

Desired means to avoid contamination or cross contamination: The edges of the equipment should be given a good finishing without having any ups and downs, should be 100% isolated on gasket usage for tightening.

Any other specific GMP Requirement: NA

That's it........!!! Now,

4. Safety Requirements: The following will fall under safety requirements,

Desired Process/Product safety systems, Desired Personal safety systems, Any other Specific safety Requirements.

For the GLR,

Desired Process/Product safety systems: All the documents that were prepared should be 100% perfect and adhere to the facility,

Desired Personal Safety Systems: All electric wirings should be concealed and earthing should be given to avoid the static charge.

Any other Specific Safety Requirements: NA

that's it........!!

5. Document Requirements: the following document lists were needed.

Desired Documents, Any other specific documents required.

For the GLR it will be like,

Desired Documents: 

• Drawings : Engineering Drawings like P & ID,
• Certificates: Instrument calibration certificates, Material specification and test certificates, 

Any other Specific Documents: All Utilities lines were connected accurately, all Safety documents were accounted for.

That's it......!! Now, we have reached the end it will be Time for......

6. Discussion / Comments / Review: This simply includes the discussion over the above data and then search for missed things, add them into the categories, and then make a review, then the QA will make their comments over it....!!!

7. URS Approval: After getting Positive comments from QA officers, it will be approved.

This is the sequence of the URS, so now if you wanna add something to the above, just comment below in comment box, if you thing you gained something after reading this just raise your thumbs up.......!! And say Cheers........!!!

Any queries on above information..... Feel free to contact me,

Comments are most appreciate........!! 

/* NOTE: The above furnished information is of my Knowledge, not copied one */


About The Author

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Hi! I am Ajay Kumar Kalva, Currently serving as the CEO of this site, a tech geek by passion, and a chemical process engineer by profession, i'm interested in writing articles regarding technology, hacking and pharma technology.
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