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User Requirement Specification (URS) Area: Development, Production & Quality Control URS Reference No:

URS001/07

Effective Date:

Version No:

1 draft 1

Periodic Review Date:

USER REQUIREMENTS SPECIFICATION (URS) FOR A POWER PACK

NAME

TITLE

Mark Odulate

Snr Protein Biochemist

Reviewer:

Philip Ball

Analytical Manager

Approved by:

Anita Bate

Science Director

Ken Hart

Qualified Person

Author:

Authorised by (QA):

SIGNATURE

DATE

CONTENTS EDEN BIODESIGN CONFIDENTIAL - FORM.QA.026.03

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User Requirement Specification (URS) Area: Development, Production & Quality Control URS Reference No: Effective Date:

URS001/07

Version No:

1 draft 1

Periodic Review Date:

1. INTRODUCTION 3 2. OVERVIEW 3 3. OPERATIONAL REQUIREMENTS .......................................................................4 3.1 Scope ................................................................................................................................ 4 3.2 Operation ................................................................................................................................ 4 3.3 Options and Ancillaries ................................................................................................................................ 5 3.4 Interfaces ................................................................................................................................ 5 3.5 Data and Security ............................................................................................................................... 5 3.6 Environment ................................................................................................................................ 5 4. CONSTRAINTS......................................................................................................6 4.1 Milestones and Timelines .................................................................................6 4.2 Compatibility and Support ................................................................................................................................ 6 4.3 Maintenance Requirements ................................................................................................................................ 6 4.4 Procedural Constraints ................................................................................................................................ 6 5. LIFE CYCLE........................................................................................................... 6 5.1 Development Procedures ................................................................................................................................ 6 5.2 Testing Requirements ................................................................................................................................ 7 5.3 Delivery Requirements ................................................................................................................................ 7

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User Requirement Specification (URS) Area: Development, Production & Quality Control URS Reference No:

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5.4 Support ................................................................................................................................ 7 6. GLOSSARY 7 7. REFERENCES AND ASSOCIATED DOCUMENTS 8 8. VALIDATION REQUIREMENTS 9

1.

INTRODUCTION The National Biomanufacturing Centre (NBC) is located on the Estuary Development site in Speke, Liverpool, UK. The functional areas of the facility include a current Good Manufacturing Practice (GMP) Production Area (comprising 3 production suites and a support area), Warehousing and Storage areas, Analytical, Quality Control (QC) and Process Development labs and offices. The NBC facility provides biopharmaceutical process development and clinical trial phase I and II production, including supporting analytical and QC activities. The drug substances produced are intended for medicines for human use and as such are governed by current Good Manufacturing Practice (cGMP). This URS describes the operational, environmental and cGMP requirements of the power packs, which will be used in the Analytical Development / QC laboratories.

2.

OVERVIEW The power packs will be used in the following applications: SDS PAGE, western blotting, IEF, 2D gels and horizontal electrophoresis within the Analytical Development Laboratories. They must have ground leakage detection and short circuit/over load detection to protect the user.

EDEN BIODESIGN CONFIDENTIAL - FORM.QA.026.03

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User Requirement Specification (URS) Area: Development, Production & Quality Control URS Reference No:

URS001/07

Effective Date:

Version No:

1 draft 1

Periodic Review Date:

3.

OPERATIONAL REQUIREMENTS

3.1

Scope The power packs will require low maintenance, and be designed for ease of use. The Vendors scope shall include the following: a) Supply. b) Installation. c) Documentation including calibration certificates. d) User training. e) Details of service / maintenance contracts available.

3.2

Operation The power packs will provide the following operational parameters: •

The units will be capable of constant current, voltage with automatic crossover.

Output specification: 250 V, 3.0 A, 300 W

Voltage: 5-250 V (in programmable increments of 1V).

Current: 0 – 2 A (in programmable increments of 1mA).

Power 1 - 300 W.

Fuse on both hot and neutral.

Operational conditions: 0 – 40oC; 0 – 95 % humidity in absence of condensation

Overload / Short circuit detection with alarm.

Auto power-up after power failure.

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User Requirement Specification (URS) Area: Development, Production & Quality Control URS Reference No:

URS001/07

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3.3

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No of terminal outputs: minimum of 2

Fully adjustable timer

Pause and resume capability

Safety compliance with EN-61010

LED display.

Options and Ancillaries The vendor should identify, where applicable, their standard equipment that fits this specification. The vendor shall (where possible) also provide costs for the following additional items: •

3.4

A range of additional maintenance support and services.

Interfaces A user-friendly control system is required, that can allow system operation with a minimal amount of training. Programming will be performed using a touch-sensitive alpha numeric interface.

3.5

Data and Security Not applicable.

3.6

Environment The equipment will be located in the Analytical Development Laboratories (ambient temperature 15-25ºC RH 10-70%). The outer casing of equipment will be constructed of non-shedding, nonstatic producing, cleanable material. The surface will be resistant to mild

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User Requirement Specification (URS) Area: Development, Production & Quality Control URS Reference No:

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acid / alkali solutions and organic solvents, and the materials of construction must be non-corrosive. The power packs must operate accurately at ambient temperature away from direct sunlight and draughts, at < 90% humidity. The power packs are required to fit on bench space 90 cm deep and 120 cm wide with no height restriction. 4.

CONSTRAINTS

4.1

Milestones and Timelines Not applicable.

4.2

Compatibility and Support The internal components of the system must be compatible with, and resistant to, the materials used during operation. The power packs must be capable of being powered by single-phase 240V (50 Hz) electricity.

4.3

Maintenance Requirements The manufacturer should supply details of any maintenance / breakdown packages available. Supplier must be able to provide routine maintenance and repair when needed beyond the warranty period at cost to the customer.

4.4

Procedural Constraints Not applicable.

5.

LIFE CYCLE

5.1

Development Procedures

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User Requirement Specification (URS) Area: Development, Production & Quality Control URS Reference No:

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Not applicable. 5.2

Testing Requirements See Section 8 for a detailed matrix of the validation testing requirements.

5.3

Delivery Requirements On supply the following documentation should be supplied: •

5.4

Operation and maintenance manual (including manufacturer’s recommendations for maintenance schedules).

Calibration certificates.

Parts list and spares requirements.

System specifications.

Support The vendor must supply details of all service and maintenance requirements of the equipment. The vendor must also supply details of any service and maintenance support that they can supply.

6.

GLOSSARY cGLP

Current Good Laboratory Practice

CFR

Code of Federal Regulations

cGMP

current Good Manufacturing Practice

EC

European Community

EEC

European Economic Community

GAMP

Good Automated Manufacturing Practice

GMP

Good Manufacturing Practice

IEF

Isoelectric focusing

IOQ

Installation / Operational Qualification

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User Requirement Specification (URS) Area: Development, Production & Quality Control URS Reference No:

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ISPE

International Society of Pharmaceutical Engineers

NBC

National Biomanufacturing Centre

Ph Eur

European Pharmacopoeia

QC

Quality Control

RH

Relative Humidity

URS

User Requirement Specification

USP

United States Pharmacopoeia

REFERENCES AND ASSOCIATED DOCUMENTS The power packs should be fully compliant with the following documents/regulations: a)

GMP-EC directive 91/356/EEC - Principles and Guidelines of Good Manufacturing Practice for Medicinal Products for Human Use.

b)

cGMP - United States Code of Federal Regulation (CFR) Title 21, Parts 210 and 211 - Current Good Manufacturing Practice.

c)

cGMP - United States Code of Federal Regulation (CFR) Title 21, Part 11 - Current Good Manufacturing Practice.

d)

GAMP - International Society of Pharmaceutical Engineers (ISPE) Guide to Good Automated Manufacturing Practice.

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User Requirement Specification (URS) Area: Development, Production & Quality Control URS Reference No:

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VALIDATION REQUIREMENTS

The following details the test requirements for documentation, testing and the stage of the project at which they must be provided/performed. These requirements are a minimum tariff and the vendor is required to include any documentation, not all ready requested here, which are considered necessary to support successful validation of the system. Test Requirements

Test Stage Tender

Documentation and drawings

Example Calibration Certificates

Y

Vendor to supply the specified documentation as a minimum

System Technical Specification

Y

Operational Testing

Impact assessment/ Installation

Operation and Maintenance Manual

Y

Calibration Certificates

Y

Testing which demonstrates that the equipment operates a Precise, Accurate and reproducible manner Parts List and Spares requirements

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Y

Y

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