User Requirement Specifications in the Pharmaceutical Industry

In the pharmaceutical industry, delivering safe and effective products is paramount. To ensure compliance with regulatory standards and meet the needs of end-users, pharmaceutical companies employ a systematic approach known as User Requirement Specifications (URS). URS serves as a blueprint for designing, developing, and validating pharmaceutical equipment and processes. In this article, we delve into the intricacies of User Requirement Specifications, their importance, and best practices for creating them within the pharmaceutical industry.

What are User Requirement Specifications (URS)?

The URS means User Requirement Specification is a first document to define the procedure for the procurement of any equipment. The user requirement specification document should be very clear why we need this equipment and for which area and application.

User Requirement Specifications also known as URS is a document, which describe the basic requirement of any Equipment, Instrument, System or Facility in terms of Make, Model, capacity, Process, Control System and other cGMP requirements.

Understanding User Requirement Specifications

User Requirement Specifications (URS) form a crucial component of the pharmaceutical industry's quality management systems. URS outlines the functional, operational, and performance requirements that a pharmaceutical product or process must meet to satisfy user expectations. These requirements encompass a range of factors, including safety, efficiency, accuracy, reliability, and regulatory compliance.

Basic Flow for Preparation of the URS is as below:

• Generally, URS is prepared by the Person from the user department.
• After preparation of the URS it will be reviewed by user department, engineering department, Quality Assurance. If required, it can be reviewed by other cross-functional department also.
• After review by a cross-functional department, it will be sent to QA Head for approval.
• Once the URS is approved, it will be sent to the Vendor for approval. Once approved by vendor, the purchase order shall be raised.
• In some cases where equipment is commercially available, URS may not require to be prepared. For such equipment, technical & functional specification from vendor can be considered as URS. For example, in-process testing instruments like Hardness Tester, etc.

A properly written URS helps the supplier or vendor to fully understand the client’s requirements. This, in turn, helps the supplier design a system or specialized equipment that completely satisfies needs and expectations. Alternatively, if there is no URS, it can create confusion between both parties blaming each other for failures resulting in the waste of time and resources.

A URS also helps with the completion of regulatory requirements. Some regulatory bodies require that the URS is completed before the purchase of any equipment. It also forms a basis for validation activities, including installation qualification (IQ) and operational qualification (OQ).

During User Requirement speciation preparation keep the documents as per all the regulations like environmental safety, machine safety controls, and health shall be considered.

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Best Practices for Creating User Requirement Specifications

1. Collaboration: Collaboration between different stakeholders, such as end-users, process engineers, quality assurance personnel, and regulatory experts, is vital during the creation of User Requirement Specifications. This ensures that all perspectives are considered and that the URS accurately reflects user needs and regulatory requirements.
2. Clarity and Specificity: The URS document should be clear, concise, and specific in defining the requirements. Avoid vague statements and ambiguities. Use measurable criteria whenever possible to facilitate objective evaluation and validation.
3. Traceability: Ensure that each requirement in the URS is traceable to its source, whether it be user needs, regulatory guidelines, or industry standards. This traceability allows for effective verification and validation of the final product or process.
4. Relevance and Feasibility: Each requirement specified in the URS should be relevant to the intended use of the product or process. Avoid unnecessary or unrealistic demands that may hinder the development or result in excessive costs. Focus on essential features that add value to the end-user.
5. Revision and Review: User Requirement Specifications should be periodically reviewed and revised throughout the product lifecycle. As new insights and user needs arise, updating the URS ensures that the product or process remains aligned with the latest requirements and market demands.

The following guidelines should be followed during the preparation of the URS:

• Each requirement statement to be uniquely referenced and no longer those 250 words
• Requirement statements should not be duplicated or contradicted.
• The URS should express requirements and not design solutions.
• Each requirement should be testable.
• The URS must be understood by both user and supplier; ambiguity and jargon / terminology should be avoided.
• The use of diagram is often useful.

• The scope for readers to make assumptions of misinterpret should be minimized.
• Wherever possible, the URS should distinguish between mandatory / regulatory requirement and desirable features.

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Points should be considered in the user requirement specification format or Key Sections of a URS:

Sr. No.	Headings	Description
1.	Objective	To establish specification for Equipment / system to be install at Site / Name of Company as per requirement of their intended use and cGMP compliances
2.	Scope	This URS is applicable to the Equipment / System that will be installed at Site / Name of Company
		The manufacturer/supplier shall be responsible for the supply of the following system outlined in this specification including design, engineering, fabrication, materials of construction (MOC), inspection, testing and certification of material, specified documentation, packaging, delivery, installation, commissioning validations, calibrations, performance guarantee of the materials and equipment supplied.
3.	System Description
	Description	A short Description of Equipment which are required with its principle
4.	General Requirements
	Name of Equipment	Mention the Name of Equipment to be required
	Client	Name of Client / Company
	Area of Installation	Name of Area the Equipment to be Installed
	Dimension and Environmental Condition	Dimension & environmental condition in which equipment can be run based on the room where equipment will be installed.
	Capacity	The Capacity of Equipment to be required for the intended purpose
	Material of Construction and Finishing	Mentioned the MOC with its Smoothness Finishing (Ra) to be required.
	Design of Equipment	Required of mention the Design of Equipment like GMP Model or any other
	Usage of Equipment	Mention the minimum working hour of equipment.
	Process Requirements	A brief detail of the process of the equipment with connectivity of other area and equipment if required
	Technical Requirements	If any specific technical requirement regarding the process of the equipment
	Utility Requirement	A brief details of utility requirement for the Equipment / System
5.	Components Details
	Name of Major Component/s	Details of Major Components with Preferred Make, Model, Capacity, Range, etc.
	Name of Minor Component/s	Details of Minor Components with Preferred Make, Model, Capacity, Range, etc.

6.	Material of Construction
	MOC	Give the details about the material of construction like stainless steel and its grades and Certificates of same shall be required.
7.	Control Systems
	MMI	Preferred Make, Type, Model, etc.
	Data Security	Audit trail
	PLC	Mentioned the Details of Make, Model, Type
	User Interface	Mention if required to be compatible with SCADA or DCS
	Interface to other	Mention if required interface with other Equipment / System / Instrument
	Data storage Capacity	Minimum Storage Capacity
	Password Protection	Mention the Required Password Protection up to 3 Level
	Software Specifications	Preferred Make, Type, Version, etc.
	Hardware Specifications	Preferred Make, Type, Model, etc.
	Others	Specify if any other object is required
8.	Alarms, Interlock & Safety Features
	Alarms	Mention the all required alarms in equipment
	Interlock	Mention all required interlocks in equipment
	Safety Features	Mention Safety features like emergency switch Earthing, Power Failure Noise Level Flame Proof / Non-Flame Proof
		IP Rating etc.
	Other	If Any other Safety Precaution is Required, Please Specify

9.	Documentation
	Functional Specification	Should be Required
	Test Specification	Should be Required
	Certificates	Mentioned the Requirements of Certificates Like Material of Construction, Components Test Certificates, Calibration Certificates, Performance Test Certificate etc.
	Manual	Mention the requirement of the Operation & Maintenance Manual
	Drawings	Mentioned deferent type of drawing required like GA, P&ID, Electrical, etc.
	Recommended SOP	Standard Operating Procedure for Cleaning, Maintenance and Operation Required
	FAT / SAT	Mention if Factory Acceptance Test or Site Acceptance Test is required
	Qualification Documents	It includes the FAT, Design, SAT, Installation, Operational & Performance Qualification
	Calibration Certificates	The Calibration Certificates for all instrumentation and Test Certificates for Major Components like Motors, Pumps, Gear Box etc.
	Software	All documentation is required for Software and Verification Test, PLC Validation and its documentation
	Guarantee Certificates	Vendor shall provide full and complete Guarantee for one year's trouble-free performance from date of successful commissioning / final acceptance.
	Others	Please specify if any other document is required
10.	Scope of Vendor	The Vendor must comply with good documentation practice and deliver the necessary documentation to prove that the Purified Water System with its equipment is constructed according to GMP guidelines and in line with our URS. Thus, it must be documented that the materials used are compliant with GMP guidelines and the appropriate validation tests have been performed. Commissioning is performed by the Vendor and is defined as the process by which the systems and equipment are tested to ensure / verify that the design of the system is fit for its intended use, according to Good Engineering Practice (GEP). The commissioning process starts at the pre-design phase and continues through construction until the final qualification is performed; it can be divided into phases of pre-design, design, construction and operation. The (equipment / System) , with all options, equipment, and the documentation shall be delivered to the User’s receiving address Which are mentioned in PO. The vendor shall provide a full description of the equipment and the vendor shall specify the dimensions of all items. The Supplier / Vendor shall provide a training course to Operational & maintenance people on troubleshooting and repair of the system . The Supplier shall identify components items are mounted on the skid that are kept in inventory at the supplier. Installation, operation, and maintenance instruction documentation for the system shall be developed to a level that is comprehensible to a high school +Industrial technician course. The Supplier shall provide the documentation for preliminary review. The Supplier shall provide documentation reflecting “as-built” condition with final delivery. All final documents shall be shipped with transmit that identify them as contractually required documents. All final documents and drawings shall reflect “as-built” condition. All documents shall in the English language and supplied with hard copies and electronic versions supplied in the format identified for each document: Training- vendor to include scope of training for user deputed personnel at site and at vendors’ formal training center/school. Post Start-up Support –Vendor to depute software-programming engineer for any minor changes if required after running the system for three to six months. The User Requirement Specification has been discussed and agreed upon. We hereby declare that we will supply the equipment / system as per above laid down specification.
11.	URS Approval
	Prepared By  User	Name, Sign & Date of Person who has prepared URS
	Reviewed By User	Name, Sign & Date of Person who has prepared URS
	Reviewed By Engineering	Name, Sign & Date of Person who has prepared URS
	Reviewed By Health and Safety	Name, Sign & Date of Person who has prepared URS
	Approved By Head QA	Name, Sign & Date of Person who has prepared URS
12.	URS Acceptance By Vendor	The User Requirement Specification has been discussed and agreed upon. We hereby declare that We will supply the equipment / system as per above laid down specification. Name, Sign & Date of Vendor who has Accepted the URS

Conclusion

User Requirement Specifications serve as a cornerstone in the development of pharmaceutical products and processes. By defining essential functionalities and performance criteria, URS ensures regulatory compliance, risk mitigation, and enhanced product quality. Through collaboration, clarity, traceability, relevance, and periodic review, pharmaceutical companies can create effective User Requirement Specifications that align with user expectations and industry standards. Adopting a robust URS framework empowers the pharmaceutical industry to deliver safe and efficacious products, fostering trust among end-users and regulatory authorities alike.

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