Insert Company

Logo here Document ID: Document ID Version No.: Version No

User Requirement Specification: User Requirement

Specification Template

Document authorship and approvals

Author signs to confirm technical content
Prepared by: Job title: Signature: Date:

Subject matter expert reviewer signs to confirm technical content

Reviewed by: Job title: Signature: Date:

Quality representative signs to confirm document complies with quality management system
Authorised by: Job title: Signature: Date:

Document review date

Page 1 of 11
 User Requirement Specification: User Requirement Specification
Template
Company

Document ID: Document ID Version No.: Version No

Contents
1. Introduction 3
2. Objective 3
3. Scope 3
3.1. In-Scope 3
3.2. Out-of-Scope 3
4. Criticality & Risk Assessment 4
4.1. Criticality 4
4.2. Risk 4
4.3. Testing Requirements 4
5. Requirements 5
5.1. Compliance Requirements 5
5.2. Process & Operational Requirements 5
5.3. Constraints 8
5.4. Life-Cycle Requirements 8
6. Referenced Documents 11
7. Definitions 11

Notes
Fields marked [Company] or [Title], etc. can be updated within the document and should
change all other references to the field instantly.
All text provided is either instructional (red text) or example (black text) and should be
modified/deleted as appropriate.
Because URS can apply to very small and very large projects, it is difficult to provide examples
of requirements to cover all eventualities. The example text provided is for a small HVAC
system. It demonstrates how requirements should be written, but clearly cannot cover
requirements for all equipment types

Page 2 of 11
 User Requirement Specification: User Requirement Specification
Template
Company

Document ID: Document ID Version No.: Version No

1. Introduction
This should be a very brief introduction how this URS has arisen and what it is for.
Company is constructing a new manufacturing facility in Company Address . As part of this
new facility, a User Requirement Specification Template is required. This User Requirements
Specification (URS) documents the user and regulatory requirements for the User
Requirement Specification Template. The URS will be used as the basis of design and
qualification for the User Requirement Specification Template.
Note: in some cases, the URS is not the basis for design, and in some other cases, ‘selection’
may be a more appropriate term where there is no design phase involved.
It is also possible that a URS has been prepared retrospective to order. In these cases, the
introduction should make this clear and justify the position.

2. Objective
The objective of this URS is to define and document the requirements of the User
Requirement Specification Template at Company Address , including:
 design
 construction
 qualification
 operation
Appropriate definition and application of these requirements will result in an operational
facility in compliance with all user requirements as well as applicable regulatory requirements.

3. Scope
What is in and out of scope may vary from one URS to another. These sections should be
edited accordingly.

3.1. In-Scope
The scope of this URS is limited to the User Requirement Specification Template at Company
Address. The plans and schedules provided in attachment 1 clearly identify the limit of supply.
The URS details the following requirement types:
 compliance requirements
 process and operational requirements
 constraints
 life cycle requirements
The URS describes all the requirements deemed relevant to the items above for the User
Requirement Specification Template. Testing for each requirement is determined through
criticality and risk assessment as described in Section 4.

3.2. Out-of-Scope
This URS does not include:

Page 3 of 11
 User Requirement Specification: User Requirement Specification
Template
Company

Document ID: Document ID Version No.: Version No

 statutory construction requirements, considered the responsibility of the builder and their
sub-contractors;
 architectural or engineering functional or detailed design, considered the responsibility of
the contracted designers;
 statutory requirements for occupational health, safety and environment, considered the
responsibility of the contracted designers.
 The URS is not applicable to general office and other areas not directly required for the
operation of the GMP facility

4. Criticality & Risk Assessment

4.1. Criticality
The User Requirement Specification Template has been assessed in accordance with SOP002 -
Criticality and Risk Assessment as follows:

Parameter Assessment Justification

Impact One of For example

Direct Product contact / controls critical parameters
Indirect Monitors critical parameters / required for compliance
Safety Personnel protection only
None Not required for GMP or safety compliance

4.2. Risk
This URS has been completed in accordance with SOP002 - Criticality and Risk Assessment.
Each listed requirement has been assessed for risk and assigned a Risk Priority (High, Medium
or Low). This risk priority should be used to make priorities for design and/or testing
requirements.
Each risk priority identifies the risk to product quality and/or other risks as deemed relevant if
the requirement is not implemented, or implemented incorrectly. The risk priority is
determined by analysis of:
 the severity of the risk event
 the probability of detection before occurrence
 and the likelihood of its occurrence without intervention.
This risk assessment has identified:
16 requirements of High risk priority
32 requirements of Medium risk priority
19 requirements of Low risk priority

4.3. Testing Requirements

Modify the level of testing required to suit the categorisations obtained.

Page 4 of 11
 User Requirement Specification: User Requirement Specification
Template
Company

Document ID: Document ID Version No.: Version No

Based on the risk and criticality categorisations above and in accordance with SOP002 -
Criticality and Risk Assessment for Validation and VMPXXX –Validation Master Plan, User
Requirement Specification Template requires Commissioning, followed by Design, Installation,
Operational and Performance Qualification as minimum testing requirements.
The level of testing conducted for each requirement shall be commensurate with the risk
priority identified in the requirements table in Section 5.

5. Requirements

Ref. Requirement Risk

5.1. Compliance Requirements

List all compliance requirements which must be met by the completed project. GMP
code(s) and guidances, ISO or national standards, OH&S requirements, building
codes, corporate policies, etc. may be listed here.
Redundancies (for example, building codes already referenced in tender packages or
design briefs) should be avoided, however.
U1. The User Requirement Specification Template shall comply with the requirements M
of Good Manufacturing Practice (GMP) for medicinal products, as regulated by the
Therapeutic Goods Administration (TGA) in Australia (PIC/S Guide to Good
Manufacturing Practice, PE009-8).

U2. The User Requirement Specification Template shall comply with the relevant M
requirements for manufacture of Sterile Medicinal Products, as regulated by the
TGA in Australia (PIC/S Guide to Good Manufacturing Practice, PE009-8, Annex 1).

U3. Classification of the HVAC system shall be performed in accordance with ISO L
14644 or AS 14644.

5.2. Process & Operational Requirements

List all process and operational requirements to be met by the completed project.
Consider capacities, performance specifications, layout, cleaning requirements,
waste handling, environmental requirements, finishes, storage requirements,
materials and personnel flows, etc.
General

The system shall supply a floor space of approximately 400m2, partitioned as

U4. described in requirements U14 to U27. The system shall have no less than 2 air H
handling units (AHU) to supply approximately 8m3/s of air to the facility.

Temperature control shall be by cooling and reheat coils in each AHU, supplied by
U5. M
chilled and heating hot water systems dedicated to the HVAC system.

The HVAC systems shall feature an energy saving mode for idle periods and shall L
U6. automatically increase the temperature set-point in all supplied rooms to 22°C for
those periods.

Page 5 of 11
 User Requirement Specification: User Requirement Specification
Template
Company

Document ID: Document ID Version No.: Version No

Visible and audible alarm(s) shall be provided to indicate non-compliant room H

U7.
pressures.

U8. Terminal filters shall be provided to achieve the required degree of air quality. M

Pre-filters shall be installed as appropriate to enhance the life of primary or L

U9.
terminal filters.

Grade C and higher classifications shall be achieved through the use of terminally H
U10. mounted HEPA filtration (H13 or above), or similar pre-approved filtration, to filter
supply air.

Return air from Manufacturing 1 shall be HEPA filtered at the face of the return air M
U11.
duct to facilitate containment of cytotoxic materials.

U12. Terminal HEPA filters shall be bottom accessed for testing and replacement. L

Separate HVAC systems shall be supplied to service the cytotoxic and non- M
U13.
cytotoxic areas of the facility.

Air Service Requirement

Temp Air Changes Pressure

Room Grade Risk
(°C) (no./hr) (Pa)

U14. R02 – Change Airlock D 20±2 ≥15 10 M

U15. R03 – Corridor D 20±2 ≥15 10 M

U16. R04 - Workstations D 20±2 ≥15 20 M

U17. R05 – Wash Up Area D 20±2 ≥15 20 M

U18. R06 – Packaging Area D 20±2 ≥15 20 M

U19. R07 – Manufacturing 1 B 18±2 ≥40 20 H

U20. R08 – Personnel Air Lock 1 C/B 18±2 ≥30 40 H

U21. R09 –Personnel Air Lock 2 C/B 18±2 ≥30 40 H

U22. R10 – Manufacturing 2 B 18±2 ≥40 60 H

U23. R11 – Entry Airlock U/C 22±3 NA Ambient M

U24. R12 – Cold Room U/C 5±3 NA Ambient H

U25. R13 – Received and U/C 22±3 NA Ambient M

Dispatched Goods Area

U26. R14 – Loading Bay and U/C 22±3 NA Ambient L

Setting Down Area

Page 6 of 11
 User Requirement Specification: User Requirement Specification
Template
Company

Document ID: Document ID Version No.: Version No

U27. R15 – Packaging & Raw U/C 22±3 NA Ambient L

Materials Store

1. Room pressures are target values. Variation from the target of up to 5 Pa is permissible,
provided the intent of the pressure cascade is not compromised, and a minimum differential pressure
of 10 Pa is maintained where there is a change of grade.
2. Room Grades are defined by PIC/S Guide to Good Manufacturing Practice, Annex 1, except:
a) Airlocks designated C/B are nominally Grade C “in operation” for the entire room, while the
area immediately prior to cleanroom entry must meet Grace B in the ‘at rest’ condition.
b) Rooms designated U/C are unclassified, but controlled areas.

Personnel Airlocks for entry to Grade B areas shall be nominally Grade C, but meet H
U28.
grade B ‘at rest’ in their final stage before entry to the manufacturing suites.

The HVAC systems shall achieve (or better) the specifications detailed above and H
U29. shall be qualified to verify that the specified conditions have been achieved in the
‘at rest’ state, in accordance with PE009-8 Annex 1 and ISO 14644.

Finishes & Cleaning

U30. The insulation inside the air handling units shall be non-shedding. L

U31. The air handling units shall be provided with adequate access for cleaning. L

U32. Ductwork shall be run above the ceiling. L

Ductwork construction shall be GMP compliant, rigid sheet metal where practical L
U33.
and with external insulation where appropriate.

The location of make-up air inlets shall be carefully selected to avoid the M
U34.
opportunity for contaminated air to be introduced.

Air supply points to classified rooms shall be selected considering the following H
criteria in order of priority:
U35.
 Minimise interference with laminar flow/cytotoxic safety cabinet operation
 Maximise the mixing of air in order to minimise the room recovery time

Visible and calibratable room pressure indicators for all critical rooms shall be M
U36.
installed in centrally located panel(s) to simplify routine monitoring.

Electrical Requirements

U37. Power cabling shall be run in dedicated cable tray or in conduits. L

The system shall be connected to a back-up generator to ensure minimal H

U38.
interruption of operation during power failure.

Hydraulics Requirements

Chilled water and heating hot water piping shall be labelled with name of service L
U39.
as well as flow direction where appropriate

Page 7 of 11
 User Requirement Specification: User Requirement Specification
Template
Company

Document ID: Document ID Version No.: Version No

5.3. Constraints
List all constraints that define the boundaries/limitations of the project, and which
are not inherent in the previously listed requirements. Consider space constraints,
site service availability, project time constraints, site standards and policies,
compatibility requirements with existing systems and equipment
Scheduled modification to building structure works requires completion and
U40. L
handover of the system prior to December 31, 2011.

The system shall be available 24 hours per day, 7 days per week. Routine
U41. M
maintenance events requiring system shut-down should be kept to a minimum.

U42. All componentry for the installation must comply with ENG-XXX Site Engineering L
Standards, except where written approval of the engineering department has been
obtained.

U43. The system shall be constructed in the existing space identified in the plans in L
Attachment 1.

U44. Heating Hot Water and Chilled Water Services shall be connected to existing water L
mains connections available as indicated on the plans and schedules attached in
Attachment 1.

U45. Electrical components shall be compatible with the available electrical supplies of M
240V single phase and 415V 3 phase.

U46. The system is required to interface with the site Building Management System. M

U47. The system shall be designed with an intended life of no less than 15 years. L

5.4. Life-Cycle Requirements

Define the post-design requirements for accepting the equipment, such as
documentation, testing and warranty support.
Design Review

During the design phase, and as part of final design approval, design team meetings will be
conducted. The outcomes of these meetings will be recorded and compiled by Company as the
design review.

The design review shall demonstrate that the design meets all relevant user, H
U48.
functional, design, regulatory and compliance requirements.

Commissioning Requirements

At the completion of installation, the system shall be commissioned by the installer and/or
subcontractors to the installer, prior to handover to Company. The following are the minimum
requirements for commissioning.

U49. All personnel performing commissioning testing shall supply evidence of M

Page 8 of 11
 User Requirement Specification: User Requirement Specification
Template
Company

Document ID: Document ID Version No.: Version No

accreditation by a relevant testing authority (e.g. NATA).

Tester shall supply documented evidence that the requirements of this URS have M
U50.
been met where appropriate.

U51. All HEPA filters shall be integrity tested in accordance with AS 1807.6 and 1807.7. M

All classified rooms shall be classified ‘at-rest’ in accordance with ISO 14644-1 and M
U52.
14644-3.

Recovery rate testing shall be performed for all Grade B rooms, in accordance with M
U53.
ISO 14644-3, B12.3.1.

Uni-directional flow velocity testing shall be performed all in Grade A zones, in M

U54.
accordance with ISO 14644-3, B4.2.2.

Certificates of compliance with relevant standards (e.g. Australian Standards) shall L

U55.
be supplied where applicable.

Handover Documentation Requirements

The installer shall supply an operation and maintenance manual which includes as M
a minimum:
 Identification of component parts and supplier literature for all components
which may require replacement
 Operating instructions for the system, and for individual components where
U56. appropriate
 As-built system layout drawings
 As-built system specifications
 Contact details for suppliers and maintenance contractor(s)
 Preventative maintenance task list with recommended frequencies

The installer shall supply a commissioning record with details and results of all M
U57.
commissioning tests and testers.

QMS Documentation Requirements

Company shall ensure that the following SOPs have been created and/or updated H
for the system:
 operation
U58.  monitoring
 calibration
 maintenance
 cleaning

Qualification Requirements

At the completion of commissioning, the system shall be qualified by Company and/or by consultants
to Company, The following are the minimum requirements for qualification.

Page 9 of 11
 User Requirement Specification: User Requirement Specification
Template
Company

Document ID: Document ID Version No.: Version No

The system shall require Installation, Operational and Performance Qualification in M

U59.
accordance with the assessment performed in Section 4.

U60. Qualifications shall be completed prior to routine use of the system. M

Life-cycle Testing

All controlling and monitoring sensors/displays for room pressure, temperature M

U61. and humidity shall be added to the site calibration register and calibrated in
accordance with the frequency determined for each item.

HEPA filter integrity testing shall be added to the site validation register and H
performed at the following frequencies:
U62.
 Filters supplying Grade A zones shall be tested 6 monthly
 Filters supplying Grade B and C zones shall be tested annually

All room and zone classification shall be added to the site validation register and H
U63.
conducted annually.

Maintenance

The system shall be installed with a warranty period of no less than 12 months on L
U64.
all parts and labour.

The routine preventative maintenance schedule shall be included on the site M

U65.
maintenance register.

Training

Training shall be provided to all operations and maintenance personnel and cover M
U66. operation, monitoring, cleaning, safety, calibration and maintenance. Training shall
be documented and maintained.

Change Control

Changes made to the system after approval of the URS shall be subject to change M
U67.
control.

Page 10 of 11
 User Requirement Specification: User Requirement Specification
Template
Company

Document ID: Document ID Version No.: Version No

6. Referenced Documents
The following documents may assist in the understanding of this specification

Document Number Document Title

7. Definitions
Term/abbreviation Definition

DOCUMENT END

Page 11 of 11
 Validation Project Plan: User Requirement Specification
Template
Company

Document ID: Document ID Version No.: Version No

Change History

Version number Date Description of change

01 MMM-YY First issue.

Change history page 1 of 1