User Requirement Specification

The pharmaceutical industry unlike other industries is highly regulated and requires dedicated processes and control for every part involved in product manufacturing. User Requirement Specification is also one of the many parts, used to describe the requirements of the required pharma equipment. It helps a Pharma manufacturer to define its requirements to achieve specific goals with that equipment. Without a comprehensive URS, it is impossible to accurately and completely convey the requirements to the machine manufacturer.

URS also serves as a base for fulfilling quality requirements related to the equipment such as validation and qualification. Additionally, it also helps to solve any dispute that could arise at a later stage between the manufacturer and the buyer.

What is the URS

User Requirement Specification is an official document that describes the requirements of a buying organization, expectations, and needs it intends to fulfill from that particular equipment. It contains the details of all specifications and functionality of the new machine.

URS contains input from all relevant departments such as Quality, Engineering, and Production. These departments give their input to fulfill their specific departmental requirement. It also acts as a benchmark for later activities such as validation and commissioning. 

URs also serve to fulfill different regulatory requirements because every regulatory body emphasizes a proper and documented form to describe and state requirements. It must also be an official document that can act as a decisive factor, internally and externally.

It is prepared by taking input from all relevant stakeholders. After finalization, it is approved and sent to the machine manufacturer for their input and feedback. After the URS is agreed upon for both the machine manufacturer and buyer, machine manufacturing is started.

Regulator regulations

User Requirement Specification is the regulatory requirement for major markets such as the United States and Europe. They review the URS, during their routine inspection, and can issue a warning, if a well-documented URS is not presented to them.

Let’s discuss some regulatory regulations for the United States and Europe

United States FDA

The United States FDA does not explicitly use the term URS but emphasizes defining the machine requirement, which is achievable by a URS. 

The US FDA regulation, 21C FR 2 11 subpart D and section 211.63 “Equipment Design, Size, and Location”, states that 

Equipment used in manufacturing must be of suitable design.

 For equipment to have a suitable design, it first requires to define its requirements, which can be easily achieved by an appropriate URS

There is another guideline that is intended for software validation, known as “General principles of software validation; final guidance for industry and FDA staff”.

Section 6.2 states that the URS must be devised defining the intended use of software to an extent to which the manufacturer is dependent on the software

EU GMP

EU GMP are the regulatory guidelines for drug products in Europe and also provide a reference to the User Requirements Specification in the following

EU GMP Annex 15

Annexure 15 of the EU GMP is called Qualification and Validation, it states that the URS should include the specification for equipment, facilities & utilities, and must be quality-focused. If there are any chances of any deviation it must be mitigated at this stage. Additionally, the URS be a reference document throughout the validation activity, i.e. acceptance criteria should be set according to the specification mentioned in the URS

In another annexure of EU GMP “Annexure1: Manufacture of Sterile Medicinal Products”. In its sub-part “Equipment” the requirement of URS is described as 

“Equipment monitoring requirement should be described in the urs during development and must also be confirmed during validation”

United States Pharmacopeia

The United States pharmacopeia is a healthcare standard in the United States and provides product-specific data. The chapter <1058> “Analytical instruments qualification” includes the requirement of a URS in its updated version of the Year 2017. Before that URS was not included and the manufacturer was not bound to create a URS

According to USP 1058 version 2017, the requirement of URS is described as follows

• URS must be documented to perform reassessment for instrument group and testing

• URS is the first stage in the qualification process

• URS defines the operating range

• The operational qualification must be performed according to the URS

Importance

Let’s discuss the importance of URS, and see why it is getting traction in the pharmaceutical industry

Regulatory requirement

A URS is a regulatory requirement for advanced markets such as the United States and Europe as mentioned above. Some years back URS was not required as a part of regulatory requirements, and informal documents such as the purchase order were sufficient to explain a given equipment and acted as a reference to the design phase. However, recently regulatory bodies are focusing more and more on URS, and devising regulations for a URS, and the same is required as a dedicated document 

Regulatory bodies now require pharma manufacturers to prepare a dedicated URS, that should contain all relevant requirements of a pharma manufacturer. 

Regulatory bodies also require pharma manufacturers to refer to URS for later-stage activities such as qualification and maintenance.

Qualification activities

URs is the first stage of qualification activity and provides the way to establish acceptance criteria for equipment, which is one of the most critical attributes of qualification activities. On the contrary, if a well-prepared URS is not arranged, it will affect the definition of acceptance criteria i.e. un-realistic or out of specification will subsequently fail the activity

Help to prevent any issues

URS is an effective way to solve issues when arise, between the machine manufacturer and buyer. An appropriately written URS provides a clear guidance scope for both parties and a clear identification of roles and responsibilities.

It gives a realistic view of the deal. Especially for the equipment buyer and give them a clear idea about what are they getting for the amount paid

Different steps in the creation of URS

The creation of a URS is a time-consuming activity that requires dedicated resources. As discussed previously, URS 

forms the basis of equipment or instrument purchasing, and for this purpose it must be created thoroughly by taking input from all stakeholders

Some inputs that are required for creating a URS, include the following

Form a team

At the beginning of creating a URS, it is beneficial to form a team that dedicatedly performs this task, and should comprise all relevant departments such as the User Department i.e. production, Engineering, and Quality.

Since URS creation requires full-time, the members must be free from their routine duties and dedicatedly work on creating a URS. 

Taking input

When creating a URS, it is helpful to take inputs from all the relevant sources and can include 

• Working on the existing equipment, their shortcoming, and drawbacks

• Experience with the existing equipment or process

• Market demand or feedback about a product that has been running on the machine

• Regulatory body regulations about equipment to be used in a particular area 

• An event such as a breakdown or trouble in achieving the target production

• Environmental conditions and area availability

• Utilities available in the current manufacturing facility

• Machine manufacturer feedback

 After getting input from all the relevant parties, combine all the inputs collected in a single format to form a combined document. The final document must be reviewed by all the members for their relevant inputs

Quality department: must ensure that all relevant regulatory requirements have been incorporated. There will be no regulatory difficulty related to the machine. 

Engineering department: must ensure that all relevant engineering points, such as safety, area specification, and controls have been incorporated. Also, make sure that the machine will be easy to maintain with the help of in-house resources and tools

Production department: ensures that equipment fulfills all the production requirements and market demand.

Review, approval, and signature

After the URS is reviewed by all stakeholders it is finalized and signed by all. Higher management should also review and authorize it. 

After approvals from all necessary departments, the URS is made part of the record and sent to machine manufacturers to begin the pre-procurement process

How to prepare a URS?

Let's briefly discuss how URS is prepared with some essential information. Please note that the following list is common, and can need to add or remove some information depending on the required equipment and process.

Capacity indicates the required capacity of the machine (For example, 300 liters)

Area requirements

• Describe the dimensions of the available area, location, HVAC, and design

Speed mentions the required speed of achievement (For example, 200 bottles/min) 

Software

. Mention the software required for various features. For example, data recording, processing, and electronic record

Electrical

• This describe all requirements related to electrical panels, design components, value, capacity, and dimensions

• Wiring detail and routing. Mention if any special wiring condition is required such as IP rating or fire protection

• Components compliance, location, installation, and functionality

Mechanical

• Describe mechanical requirements for a given machine such as material of construction, belt features, drive parts, gearbox

• Pressure design values in case of parts involved in pressure 

Documentation

• Describe all the documentation requirements, such as 

• Wiring diagram, maintenance manual, troubleshooting