URS User Requirement Specification Template r01

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User Requirement Specification: User Requirement Specification Template

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Page 1 of 11

User Requirement Specification: User Requirement Specification Template

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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

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User Requirement Specification: User Requirement Specification Template

Company

Document ID: Document ID

1.

Version No.: Version No

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:

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User Requirement Specification: User Requirement Specification Template

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 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 One of

Impact

4.2.

Justification 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

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.

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User Requirement Specification: User Requirement Specification Template

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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.

5.1.

Requirement

Risk

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 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).

M

U2.

The User Requirement Specification Template shall comply with the relevant 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).

M

U3.

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

L

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 U4.

The system shall supply a floor space of approximately 400m2, partitioned as described in requirements U14 to U27. The system shall have no less than 2 air handling units (AHU) to supply approximately 8m3/s of air to the facility.

H

U5.

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

M

U6.

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

L

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User Requirement Specification: User Requirement Specification Template

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U7.

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

H

U8.

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

M

U9.

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

L

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

H

U10.

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 noncytotoxic 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 Setting Down Area

U/C

22±3

NA

Ambient

L

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User Requirement Specification: User Requirement Specification Template

Company

Document ID: Document ID

U27.

R15 – Packaging & Raw Materials Store

U/C

Version No.: Version No

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

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

H

U35.

U36.



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 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 U39.

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

L

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User Requirement Specification: User Requirement Specification Template

Company

Document ID: Document ID

5.3.

Version No.: Version No

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. U49.

All personnel performing commissioning testing shall supply evidence of

M

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

U56.

U57.



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

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

M

M

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

U58.



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. Page 9 of 11

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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.

U62.

U63.

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

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

H



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 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 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

Training U66.

Change Control U67.

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

M

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User Requirement Specification: User Requirement Specification Template

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6.

Version No.: Version No

Referenced Documents The following documents may assist in the understanding of this specification Document Number

7.

Document Title

Definitions Term/abbreviation

Definition

DOCUMENT END

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Validation Project Plan: User Requirement Specification Template

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Change History Version number

Date

Description of change

01

MMM-YY

First issue.

Change history page 1 of 1