Understanding the user requirement specification
The user requirement specification (URS) is critical to the success of any new equipment, facility or control system.
It defines the aseptic service’s requirements for the design and build of the equipment, facility and control systems. The necessary function, performance, operability and quality requirements are described to ensure the build achieves the intended purpose of the end user.
The URS will be the underpinning reference point for all stages of the design, build and validation. The contractor will use it to create a feasible design, and a detailed technical and functional design specification. It will also be used as the basis of design qualification and is the key document against which compliance will be verified at qualification and validation stages.
The URS is usually built on the less detailed User Requirement Brief (URB) which is explained further in our article about planning a new build (SPS page).
A separate URS will be required for each of the following:
- facility, such as cleanrooms
- equipment, such as isolators
- control systems, such as building management systems
- other specific elements, such as environmental monitoring systems
Templates and examples are available on request. Please contact the QA team.
Appointing the right team
The article on assembling a clean room design and build team (SPS page) describes the appointment of the commissioning team for the project, who will write the URS. Support from a third-party validation specialist is encouraged to ensure this key document sufficiently considers and defines all necessary requirements.
The team for the URS may include:
- Production Manager / Accountable Pharmacist (if Section 10 unit)
- Head of Quality Assurance
- Chief Pharmacist
- Production team leaders / operators
- Estates representatives
- third-party validation specialist
- Procurement
- Finance and contracting
Your Regional Quality Assurance specialist should be informed that you are planning a new build. They may help you develop a GMP compliant URS. Under certain circumstances and for larger projects they may join the Project Board.
Personnel involved in the execution of the URS must be named in the document.
Defining the user requirement specification
The document will define the following:
- purpose and function of the new facility, equipment, or control system and pharmaceutical processes for which it will be used
- the relevant standards to which it must comply
- operational and performance requirements
- design and build quality requirements
The URS should be a balanced description of the aseptic service’s requirements. However, it should avoid stipulating unnecessary requirements that inhibit the contractor’s flexibility to propose their optimum design.
The URS is not intended to cover all contractual requirements. Specific legislative and industry building performance standards must apply at all times and these must be specified in other documents. Examples:
- planning consent
- current Building Regulations
- Health and Safety Regulations including fire certificate
- Electricity at Work Regulations
- Work at Height Regulations
Advice from the Trust’s procurement, contracting team, Estates and subject matter experts should be sought.
Documenting the user requirement specification
The URS is likely to be lengthy and may include the following sections:
Introduction, objectives and scope
This section is a high-level overview of the purpose and function of facility, equipment or control system including the pharmaceutical processes for which it will be used.
It should include a broad description of the product profile, manufacturing methods and regulatory status of the facility. High level details of the project area, local and infrastructure or service dependencies may be useful.
General requirements
Describe the general layout and function of the facility, equipment or control system. For a facility this would include the primary function of each area and the typical occupancy level.
Design specification standards
Include a list of the minimum current standards that the facility, equipment or control system must be designed, built, installed and qualified to.
Design conditions
These are the conditions which must be achieved to meet the aseptic service’s operational and performance requirements throughout the life of the facility or equipment.
Design conditions may include:
- EU GMP grade classification
- clean up times
- pressure differentials
- air change rates
- temperature and humidity
- light and noise levels
When specifying design conditions consider future needs, potential changes in use and the natural deterioration of system performance over time. Examples include:
- The air handling unit should be specified to comply with GMP both at commissioning and throughout the projected life of the suite.
- Additional layout flexibility or spare capacity may need to be included at the design stage to accommodate extra equipment or modifications in future years.
More information can be found in the article on responding to Annex 1 EU GMP changes (SPS page) (registration required).
Finish of materials
Materials used in cleanroom construction should minimise generation of particles and permit the repeated application of cleaning, disinfectant and sporicidal agents without damage or wear. All exposed surfaces must be smooth, impervious, free from cracks or recesses, and unbroken, to minimise the shedding or accumulation of particles or microbiological contamination.
In addition to these general requirements careful specification of the materials and finish of all critical components and equipment is required, including:
- electrical fixtures and fittings
- doors
- air locks and transfer hatches
- floors, walls and ceilings
- windows, observation panels and emergency escape panels
- benching
- sinks
- lighting
- intercom
- heating, ventilation and air conditioning (HVAC) requirements including filtration and ductwork
- instrumentation and calibration
Utilities
Describe the utility requirements of the facility, equipment or control systems for example power, water, waste, air supply and extraction and gases. If contingency is required this should be stipulated, such as backup power for critical equipment.
Furniture, fixtures and fittings
Outline the minimum furniture, fixtures and fittings to be incorporated into the design and build.
An equipment schedule may be used to define if the equipment, fixtures or fittings are to be supplied and installed by the contractor, the end user, or a combination.
Fixtures and fittings are categorised into groups within the project contracts to identify responsibilities for supply and installation. It is very important at the beginning of the project to define these responsibilities to prevent delays and confusion. These groups are:
- Group 1: supply and fix by the contractor
- Group 2: supply by the user and fix by the contractor
- Group 3: supply and fix by the user
- Group 4: relocate and fix by the contractor
- Group 5: relocate and fix by the user
Key specialist equipment
The supply of specialist equipment, for example isolators will usually have a separate URS. However enough detail should be provided in your overarching URS to ensure the contractor can plan for the equipment’s installation and operation within the design and build. The main URS should identify all the specialist equipment required, and cross refer to the individual URS for each of them.
Cleaning requirements
Specify if the contractor is required to complete a builder’s clean and deep cleans prior to hand over.
Documentation
The URS must specify that the contractor provides documentation, including:
- layout and schematic drawings such as facility, individual rooms, HVAC, ductwork, mechanical and electrical and finishes
- specifications and schedules such as HEPA filters, floor, wall and ceiling finishes, doors, transfer hatches
- commissioning reports and certification
- instrument lists and calibration certificates
- operating and maintenance manuals
Validation and qualification requirements
Define the high-level requirements for each qualification stage and the responsibilities of both the contractor and the user. This should include responsibilities for creating the qualification protocols, execution and witnessing of validation, and approval of validation reports.
Training requirements
Specify the training that the contractor will provide to ensure the user can operate, maintain and clean the cleanroom facility, equipment or control system adequately and safely.
Approval
The URS must be assessed by member(s) of the commissioning team with relevant and appropriate knowledge and operational experience, including senior staff from the aseptic service.
Before approving it, they must be satisfied that the URS sufficiently defines the function, performance, operability and quality requirements necessary to achieve the intended purpose.
Once approved, the URS is a controlled document. A record of changes and version control should be maintained with no uncontrolled or unauthorised changes permitted.