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



URS008/07



Effective Date:



Version No:



1 draft 1



Periodic Review Date:



USER REQUIREMENTS SPECIFICATION (URS) FOR A SINGLE USE DISPOSABLE BIOREACTOR SYSTEM



Author:



NAME



TITLE



Mark Rayner



Process Dev Manager



Authorised by (QA):



DATE



Validation Consultant



Reviewer:



Approved by:



SIGNATURE



Anita Bate



Science Director



Ken Hart



Qualified Person



EDEN BIODESIGN CONFIDENTIAL - FORM.QA.026.03



Page 1 of 9



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



URS008/07



Version No:



1 draft 1



Periodic Review Date:



CONTENTS 1.



INTRODUCTION................................................................................................3



2.



OVERVIEW........................................................................................................ 3



3.



OPERATIONAL REQUIREMENTS....................................................................3



4.



5.



3.1



Scope.......................................................................................................... 3



3.2



Operation....................................................................................................4



3.3



Options and Ancillaries................................................................................4



3.4



Interfaces....................................................................................................4



3.5



Data and Security........................................................................................5



3.6



Environment................................................................................................5



CONSTRAINTS..................................................................................................5 4.1



Milestones and Timelines............................................................................5



4.2



Compatibility and Support...........................................................................5



4.3



Maintenance Requirements........................................................................5



4.4



Procedural Constraints................................................................................6



LIFE CYCLE.......................................................................................................6 5.1



Development Procedures............................................................................6



5.2



Testing Requirements.................................................................................6



5.3



Delivery Requirements................................................................................6



5.4



Support.......................................................................................................6



6.



GLOSSARY........................................................................................................7



7.



REFERENCES AND ASSOCIATED DOCUMENTS...........................................8



8.



Validation requirements......................................................................................9



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



URS008/07



Effective Date:



1.



Version No:



1 draft 1



Periodic Review Date:



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 is used for 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 Single use/disposable bioreactor that will be used in the Process Development laboratories.



2.



OVERVIEW The single use/disposable bioreactor will be used during development, optimisation and growth of cell culture (e.g. mammalian, insect cell/baculovirus, viral production) during biopharmaceutical process development. It will be constructed of robust, easy cleanable materials.



3.



OPERATIONAL REQUIREMENTS



3.1



Scope The disposable bioreactor 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.



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



URS008/07



Effective Date:



Version No:



1 draft 1



Periodic Review Date:



e) Details of service / maintenance contracts available. 3.2



Operation The disposable bioreactor should have/be: 







Data logging (21 CFR part 11)







The capability of retrofit to existing/3rd party control units.







Ability to use disposable or re-usable probes.







3.3



Control and real time measurement of pH, DO, temperature, agitation.



The capability of operating with different working volumes up to 20L







Be validatable







Have the required safety cut outs and over load protection.



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. Any additional accessories to fulfil the requirements indicated in section 3.2.



Interfaces A user-friendly control system is required, that can allow system operation with a minimal amount of training.



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



URS008/07



Effective Date:



3.5



Version No:



1 draft 1



Periodic Review Date:



Data and Security Not applicable.



3.6



Environment The equipment will be located in the Process 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 acid / alkali solutions and organic solvents, and the materials of construction must be non-corrosive. The Single use/disposable bioreactor must operate accurately at ambient temperature away from direct sunlight and draughts, at < 90% humidity. The Single use/disposable bioreactor is 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 single use/disposable bioreactor 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.



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



URS008/07



Effective Date:



Version No:



1 draft 1



Periodic Review Date:



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 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.



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



URS008/07



Effective Date:



6.



7.



Version No:



1 draft 1



Periodic Review Date:



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



IOQ



Installation / Operational Qualification



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



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



URS008/07



Version No:



1 draft 1



Periodic Review Date:



The Single use/disposable bioreactor 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:



URS020/05



Effective Date:



8.



Version No:



1 draft 1



Periodic Review Date:



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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IOQ