URS User Requirement Specification Template r01

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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:

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U11. Return air from Manufacturing 1 shall be HEPA filtered at the face of the return air _{duct to facilitate containment of cytotoxic materials.} M U12. Terminal HEPA filters shall be bottom accessed for testing and replacement. L U13. Separate HVAC systems shall be supplied to service the cytotoxic and

non-cytotoxic areas of the facility.

M

Air Service Requirement

Room Grade Temp _(°C) Air Changes _(no./hr) Pressure _(Pa) Risk

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

Dispatched Goods Area U/C 22±3 NA Ambient M

U26. R14 – Loading Bay and

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U27. R15 – Packaging & Raw

Materials Store U/C 22±3 NA Ambient L

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.

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

U29. The HVAC systems shall achieve (or better) the specifications detailed above and 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.

H

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

U33. Ductwork construction shall be GMP compliant, rigid sheet metal where practical _{and with external insulation where appropriate.} L U34. The location of make-up air inlets shall be carefully selected to avoid the _{opportunity for contaminated air to be introduced.} M

U35.

Air supply points to classified rooms shall be selected considering the following criteria in order of priority:

 Minimise interference with laminar flow/cytotoxic safety cabinet operation  Maximise the mixing of air in order to minimise the room recovery time

H

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

Electrical Requirements

U37. Power cabling shall be run in dedicated cable tray or in conduits. L U38. The system shall be connected to a back-up generator to ensure minimal _{interruption of operation during power failure.} H

Hydraulics Requirements

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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

U40. Scheduled modification to building structure works requires completion and _{handover of the system prior to December 31, 2011.} L U41. The system shall be available 24 hours per day, 7 days per week. Routine _{maintenance events requiring system shut-down should be kept to a minimum.} M U42. All componentry for the installation must comply with ENG-XXX Site Engineering

Standards, except where written approval of the engineering department has been obtained.

L

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

Attachment 1. L

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

L

U45. Electrical components shall be compatible with the available electrical supplies of

240V single phase and 415V 3 phase. M

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.

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

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.

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

U50. Tester shall supply documented evidence that the requirements of this URS have _{been met where appropriate.} M U51. All HEPA filters shall be integrity tested in accordance with AS 1807.6 and 1807.7. M U52. All classified rooms shall be classified ‘at-rest’ in accordance with ISO 14644-1 and _14644-3. M U53. Recovery rate testing shall be performed for all Grade B rooms, in accordance with

ISO 14644-3, B12.3.1.

M

U54. Uni-directional flow velocity testing shall be performed all in Grade A zones, in _{accordance with ISO 14644-3, B4.2.2.} M U55. Certificates of compliance with relevant standards (e.g. Australian Standards) shall _{be supplied where applicable.} L

Handover Documentation Requirements

U56.

The installer shall supply an operation and maintenance manual which includes as 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 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

M

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

QMS Documentation Requirements

U58.

Company shall ensure that the following SOPs have been created and/or updated for the system:

 operation  monitoring  calibration  maintenance  cleaning H 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.

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U59. The system shall require Installation, Operational and Performance Qualification in _{accordance with the assessment performed in Section 4.} M U60. Qualifications shall be completed prior to routine use of the system. M

Life-cycle Testing

U61. All controlling and monitoring sensors/displays for room pressure, temperature and humidity shall be added to the site calibration register and calibrated in accordance with the frequency determined for each item.

M

U62.

HEPA filter integrity testing shall be added to the site validation register and performed at the following frequencies:

 Filters supplying Grade A zones shall be tested 6 monthly  Filters supplying Grade B and C zones shall be tested annually

H

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

Maintenance

U64. The system shall be installed with a warranty period of no less than 12 months on _{all parts and labour.} L U65. The routine preventative maintenance schedule shall be included on the site _{maintenance register.} M

Training

U66.

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

M

Change Control

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6. Referenced Documents

The following documents may assist in the understanding of this specification

Document Number Document Title

7. Definitions

Term/abbreviation Definition

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Change history page 1 of 1

Change History

Version number Date Description of change

URS User Requirement Specification Template r01

User Requirement Specification: User Requirement

Specification Template

Contents

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

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



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:

4.2. Risk