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05 Urs and Fds PDF
05 Urs and Fds PDF
1 13 October, 2008
Basic RA Detail RA
Process
Manufac- Delivery/ Test Runs/ Optimi-
Engineering Installation Commiss- Production
turing Start-up sation
ioning
Functional
DQ Documentation Requirement
Specification
User Basis of
Functional Requirements Design
Specification
Basic URS
Functional Requirements
FDS
Requirements
Purchasing
Documents
Design
Technical
Documents
Specification
Specifications
Definitions!
In general:
! prepared by the user " Production / QC unit
! less technical than an FDS, technical specification, functional
requirements specification
! it is assumed that the URS includes all functional and critical
requirements, i.e. includes GMP-requirements
URS, FDS and Contract Specification are linked with each other
(example for standard equipment)
Request for quotation
revision my be required
Supplier A! Supplier B ! Supplier C!
proposal !
FDS! FDS
FDS
comparison ! DQ
CS
negotiation and
URS URS URS URS agreement on
Contract
Specification
User Production
Engineering Department
Engineering Company
System Integrator
System Manufacturer
Basic
Process-Idea R+D
Requirem.
General Requirements Production (User) URS
Extended Requirements Technical Dep. / Engineering FRS
Technical Solution Manufacturer FDS I
Agreed Technical Solution User/Techn. / Manufacturer CS
Final Design Specification User/Techn. / Manufacturer FDS II *)
• Final technical solution is not available at the time when user gives
an order to the manufacturer
• Approved FDS that exists as preliminary version is going to be
detailed during the project execution phase
• Users and manufacturers technical/validation staff jointly supervise
the development process (change control, repeat DQ when
necessary)
• The development during execution of the project is checked in
design reviews. Reviews have the character of milestones (e.g. PID
Review, Layout Review, etc …)
• The final and approved FDS is issued when the design phase is
completed
TABLE OF CONTENTS
1. INTRODUCTION.................................................................................................2
2. GENERAL REQUIREMENTS ...........................................................................3
3. FUNCTIONAL REQUIREMENTS....................................................................11
4. INFORMATION AND CONTROL SYSTEM REQUIREMENTS.................17
5. MAINTENANCE REQUIREMENTS ................................................................20
6. SAFETY AND ENVIRONMENTAL REQUIREMENTS................................20
7. SPARE PARTS .....................................................................................................22
8. QUALITY ASSURANCE ....................................................................................22
9. TESTING ACCEPTANCE ..................................................................................23
10. QUALIFICATION REQUIREMENTS..............................................................24
11. ERECTION AND START-UP.............................................................................25
12. TRAINING REQUIREMENTS ..........................................................................26
13. PACKING; SHIPMENT ......................................................................................26
14. COMMENTS.........................................................................................................27
15. 13 October, 2008
DISTRIBUTION ...................................................................................................28
• Consequences
• Manufacturer supplies a technical solution that does not
comply with the intended purpose meant by the User
• Equipment does not fit requirements and does not work at all
• Equipment works, but contains risk for product, process,
safety
• High costs for changes at a late state occur
Consequences
• The Manufacturer has limited freedom for choosing proper
solution
• Difficulties to find Manufacturers for the equipment
• Prices for the equipment are unnecessarily high
• The technical solutions might be complicated and may contain
unnecessary potential risks of failure
Consequences
• Tests can not be performed - fulfilment of acceptance criteria
can not be verified
• No documented proof of the quality is available
• No GMP compliance of the equipment
• Unexpected additional costs and time delay
what the sales man sold ! what was assumed to be required ! what has been designed !
Summary
Disclaimer:
• This presentation has been prepared upon best knowledge and it presents the view and
experience of Pharma Consulting Walther.
• The presentation reflects current guidelines, knowledge and thinking. Changes of regulatory
guidelines or interpretation thereof or new regulatory expectations may change the
applicability of the contents of this presentation.
• Parts of the presentation may not be understood or misinterpreted without the verbal
explanation given during the seminar.
• Although the statements made in the presentation in general have been presented to and
discussed with inspectors, a different approach may be required and adequate depending on
the individual situation.
• The information contained herein may be changed without prior notice.