EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

372 Pages·2015·4.52 MB·English

by  Orlando Lopez

Pharmaceutical Science / Computer Software L EU Annex 11 Guide
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Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently e
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by product specifications or marketing authorization. Annex 11 details the European
Medicines Agency (EMA) GMP requirements for computer systems.
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The purpose of Annex 11 is to provide the EMA healthcare industry with consistent cri-
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The ideas presented in this book are based on the author’s 25 years of experience
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M Orlando López
K23442 P
ISBN: 978-1-4822-4362-8
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EU Annex 11 Guide
to Computer Validation
Compliance for
the Worldwide Health
Agency GMP

EU Annex 11 Guide
to Computer Validation
Compliance for
the Worldwide Health
Agency GMP
Orlando López
CRC Press
Taylor & Francis Group
6000 Broken Sound Parkway NW, Suite 300
Boca Raton, FL 33487-2742
© 2015 by Taylor & Francis Group, LLC
CRC Press is an imprint of Taylor & Francis Group, an Informa business
No claim to original U.S. Government works
Version Date: 20150224
International Standard Book Number-13: 978-1-4822-4363-5 (eBook - PDF)
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For Edelmira and Alfonso

Contents
Preface ..............................................................................................xv
Author ............................................................................................ xix
Contributors ................................................................................... xxi
1 Introduction .................................................................................1
References ...................................................................................................5
2 SLC, Computer Validation, and Annex 11 ....................................7
Life-Cycle Principles ..................................................................................11
References .................................................................................................11
3 Annex 11 Principles ...................................................................13
Analysis .....................................................................................................13
Principle 1 ..........................................................................................13
Principle 2 ..........................................................................................15
Principle 3 ..........................................................................................17
References .................................................................................................17
4 Risk Management ......................................................................19
EU Annex 11-1, General ...........................................................................19
Related References ....................................................................................19
Analysis .....................................................................................................20
Risk Assessment ........................................................................................22
Risk Mitigation ...........................................................................................25
Risk Evaluation ..........................................................................................25
Risk Monitoring and Control ....................................................................26
Approach ...................................................................................................27
Summary ...................................................................................................28
References .................................................................................................28
vii
viii ◾ Contents
5 Personnel ...................................................................................29
EU Annex 11-2, General ...........................................................................29
Analysis .....................................................................................................29
References .................................................................................................30
6 Suppliers and Service Providers ................................................33
EU Annex 11-3, General ...........................................................................33
Analysis .....................................................................................................34
Acquisition Process ............................................................................37
Supply Process ...................................................................................37
References .................................................................................................38
7 Validation ...................................................................................39
EU Annex 11-4, Project Phase ..................................................................39
Analysis .....................................................................................................40
Primary Life-Cycle Processes ....................................................................45
Acquisition Process ............................................................................46
Supply Process ...................................................................................46
Development Process ........................................................................47
Operation and Maintenance Processes ............................................48
References .................................................................................................48
8 Data ...........................................................................................51
R.D. MCDOWALL
EU GMP Annex 11-5, Operational Phase .................................................51
Introduction ...............................................................................................51
Impact of Other Sections of Annex 11.....................................................51
Preserving the Content and Meaning of Data .........................................53
Some Data Transfer Options ....................................................................54
Manually Driven Electronic File Transfers ...............................................55
Copy and Paste/Drag and Drop Electronic Transfers ......................55
Ensuring Data Integrity .............................................................................56
Automatic Methods of Electronic Data Transfer ......................................57
Data Migration Issues ................................................................................57
Validation Considerations for Data Transfer ............................................58
Reference ...................................................................................................59
9 Accuracy Checks ........................................................................61
EU Annex 11-6, Operational Phase ..........................................................61
Analysis .....................................................................................................61