Quality system model for development and maintenance of software in pharmaceutical manufacturing:
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| Format: | Thesis Book |
| Language: | English |
| Published: |
1997
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| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Physical Description: | Getr. Zählung graph. Darst. |
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| 245 | 1 | 0 | |a Quality system model for development and maintenance of software in pharmaceutical manufacturing |c von Thomas Hefti |
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Record in the Search Index
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| adam_text | Work Overview
Part One Framework 1. Introduction 1
2. Quality Systems in Pharmaceutical Manufacturing 19
3. Computer Systems and Good Manufacturing Practice 41
4. Quality Systems for Software Development 73
Part Two Quality Manual 5. Quality System Framework 111
6. Quality System Life Cycle Processes 123
7. Quality System Supporting Activities 178
Appendices Appendix A Source Material A 1
Appendix B Acronyms B 1
Appendix C Survey Questionnaire C 1
i
Table of Content
1. Introduction 1
1.1 General Hypothesis and Thesis Context 1
1.1.1 Automated Pharmaceutical Manufacture 1
1.1.2 Process Stakeholders 4
1.2 Thesis Outline 8
1.2.1 GMP The Pharmaceutical Manufacturing Process 9
1.2.2 GSEP Software Development and Maintenance 9
1.2.3 Quality System 10
1.2.4 The missing link. 11
1.3 Work Structure 13
1.4 Research Methods 15
1.4.1 Survey of Current Practice in Computerized System Validation 15
1.4.2 Survey of Quality Awareness and Understanding 16
1.4.3 Information Sources 16
2. Quality Systems in Pharmaceutical Manufacturing 19
2.1 The Pharmaceutical Processes 19
2.1.1 Pharmaceutical Research 20
2.1.2 Pharmaceutical Development 21
2.1.2.1 Pharmacology 21
2.1.2.2 Clinical Trials 22
2.1.2.3 Drug Registration 23
2.1.3 Pharmaceutical Manufacturing 23
2.1.3.1 Materials Management 24
2.1.3.2 Production 25
2.1.3.3 Packaging 25
2.1.3.4 Quality Control and Assurance 26
2.1.3.5 Criticality Assessment of Computer Systems in Pharmaceutical
Manufacturing. 26
2.2 Good Manufacturing Practice (GMP) 28
2.2.1 The Basic Concept of Good Manufacturing Practice 28
2.2.2 U.S. Good Manufacturing Practices 30
2.2.2.1 U.S. Food and Drug Administration (FDA) 30
2.2.2.2 GMP for Finished Pharmaceuticals 31
iii
iv Table
2.2.2.3 The Position of the U.S. FDA on ISO 9000 32
2.2.3 European (EU) Good Manufacturing Practices 32
2.2.3.1 The European Single Market Concept 33
2.2.3.2 The New and the Old Approach 34
2.2.3.3 The EN 46001 Standard 35
2.2.4 Harmonizing Quality Requirements 36
2.2.5 GMP Guidelines 38
2.2.5.1 GMP Guidance for Bulk Pharmaceutical Chemicals Manufacturers...38
2.2.5.2 GMP Guide for Bulk Pharmaceuticals Excipients 39
2.2.5.3 Baseline Pharmaceutical Engineering Guide 39
3. Computer Systems and Good Manufacturing Practice 41
3.1 Computerized System Validation (CSV) 41
3.1.1 Computer Related Systems in Pharmaceutical Manufacturing 41
3.1.1.1 Categorizing Computerized System Elements 43
3.1.1.2 Computer Systems in Client/Server Environments 44
3.1.2 Process Validation 45
3.1.3 Validation Process 47
3.1.3.1 Validation Policy 47
3.1.3.2 Validation Master Plan 47
3.1.3.3 Validation Plan 48
3.1.3.4 Validation Protocol 49
3.1.4 Roles and Responsibilities 49
3.2 Regulatory Requirements for Computerized Systems 51
3.2.1 U.S. Regulatory Sources 52
3.2.1.1 FDA Bluebook and the Code of Federal Regulations 52
3.2.1.2 FDA Technical Report Software Development Activities 53
3.2.2 EU GMP Annex 11 Computerized Systems 54
3.2.3 Software Specific Requirements 55
3.3 Validation Compliance Guides : 57
3.3.1 GAMP Supplier Guide for Validation of Automated Systems 59
3.3.2 PDA Report No. 18 Validation of Computer Related Systems 69
3.3.3 The APV Guideline Computerized Systems 69
3.3.4 Validation of Control Systems A Joint Committee of GMA and
NAMUR 70
3.3.5 GMP Guidelines as Contractual Requirements 70
4. Quality Systems for Software Development 73
4.1 Quality Terms and Concerns 73
of Content v
4.1.1 Quality Awareness and Understanding 74
4.1.2 Quality System 75
4.1.3 Quality Problems in Software Development 76
4.2 Quality System Standards 79
4.2.1 ISO 9000 Quality Standards Series 80
4.2.1.1 Structure of the ISO 9000 Standard Series 81
4.2.1.2 ISO 9001: 1994 Model for Quality Assurance 82
4.2.1.3 ISO 9000 3 Guidelines for the Application of ISO 9001 to
Software 83
4.2.2 The TickIT Guide 85
4.2.3 ISO 9000 Trends 87
4.2.4 Usage of Certified Software 88
4.3 Software Development Methodology 91
4.3.1 Methodology, Methods and Standards 91
4.3.2 Methodology Characterization 92
4.3.3 Methodology and Method Selection 96
4.3.4 Software Life Cycle 98
4.3.4.1 ISO 12207 Software Life Cycle Processes 98
4.3.4.2 Life Cycle Models 100
4.3.5 The V Model Development Methodology 102
4.4 Reference Method Selection 106
4.4.1 Quality System Standard 106
4.4.1.1 ISO 9001 106
4.4.1.2 Combining ISO 9001 and ISO/DIS 9000 3 107
4.4.1.3 TickIT Combined With the ISO 9000 Series 107
4.4.2 Software Development Methodology 108
5. Quality System Framework 111
5.1 Framework Processes 113
5.1.1 Formal Quality System Requirements 113
5.1.2 Formal Quality System Solution 114
5.1.3 Quality System Management Requirements 114
5.1.4 Quality System Management Solution 116
5.1.5 Internal Quality System Audits Requirements and Solution 117
5.1.6 Corrective and Preventive Actions 118
5.2 Quality System Cross Reference 120
6. Quality System Life Cycle Processes 123
6.1 Reviewing Contracts, Tenders and Orders 125
vi Table
6.1.1 Contract Review Requirements 127
6.1.2 Contract Review Solution 128
6.2 Defining Requirements 129
6.2.1 Requirements for Requirements Definition 129
6.2.2 Solution for Requirements Definition 131
6.3 Development Planning 133
6.3.1 Planning Process 133
6.3.2 Life Cycle Model Requirements 134
6.3.3 Life Cycle Model Solution 135
6.3.4 Project Planning Requirements 136
6.3.5 Project Planning Solution 137
6.4 Quality and Test Planning 138
6.4.1 Quality Plan 138
6.4.1.1 Quality Planning Requirements 138
6.4.1.2 Quality Plan Solution 140
6.4.2 Test Plan 142
6.4.2.1 Test Planning Requirements 142
6.4.2.2 Test Planning Solution 144
6.4.3 Risk Assessment 148
6.4.3.1 Risk Assessment Requirements 149
6.4.3.2 Risk Assessment Solution 150
6.5 Design and Implementation 152
6.5.1 Development Output Requirements 152
6.5.2 Development Output Solution 154
6.5.2.1 Software Design 154
6.5.2.2 Implementation 156
6.6 Software Verification and Validation 157
6.6.1 Software Verification 157
6.6.1.1 Software Verification Requirements 158
6.6.1.2 Software Verification Solution: Traceability Analysis 160
6.6.1.3 Software Verification Solution: Evaluation 161
6.6.1.4 Software Verification Solution: Interface Analysis 162
6.6.2 Software Validation 163
6.6.2.1 Testing Requirements 165
6.6.2.2 Testing Solution 166
6.7 Acceptance 168
6.7.1 Acceptance Requirements 169
6.7.2 Acceptance Solution 170
6.8 Replication, Delivery and Installation 172
of Content vii
6.8.1 Replication Requirements 172
6.8.2 Replication Solution 174
6.9 Maintenance 175
6.9.1 Maintenance Requirements 175
6.9.2 Maintenance Solution 177
7. Quality System Supporting Activities 178
7.1 Configuration Management 178
7.1.1 Configuration Management Requirements 180
7.1.2 Configuration Management Solution 183
7.2 Controlling Documents and Data 186
7.2.1 Document and Data Control Requirements 187
7.2.2 Document Control Solution 188
7.2.3 Controlling Quality Records 189
7.3 Quality System Improvement 190
7.3.1 Improvement Requirements 191
7.3.2 Improvement Solution 192
7.3.2.1 The Capability Maturity Model 193
7.3.2.2 BOOTSTRAP 195
7.3.2.3 Software Process Improvement and Capability Determination
(SPICE) 195
7.4 Controlling Tools and Techniques 196
7.4.1 Tool Control Requirements 196
7.4.2 Tool Control Solution 197
7.5 Purchasing 199
7.5.1 Purchasing Requirements 200
7.5.2 Purchasing Solution 201
7.6 Control of Included Software Product 203
7.6.1 Customer supplied Product Requirements 203
7.6.2 Customer Supplied Product Solution 204
7.7 Training 205
7.7.1 Training Requirements 205
7.7.2 Training Solution 206
Appendix A Source Material A 1
Appendix B Acronyms B 1
Appendix C Survey Questionnaire C 1
viii Table
List of Tables
Table 1 1 Stakeholders Interactions 5
Table 1 2 Thesis Reading Guide 13
Table 1 3 Survey Sample Data Details 15
Table 2 1 Criticality Analysis of Manufacturing Activities PeSain/Vercimak 1994] 27
Table 3 1 Regulatory Requirements Applicable to Computerized Systems 53
Table 3 2 U.S. and EU Regulatory Requirements for Computerized Systems 56
Table 3 3 GAMP Supplier Requirements Analysis 64
Table 3 4 GAMP Supplier Requirements Analysis Appendices 68
Table 4 1 Software Certification Benefits and Risk Analysis 90
Table 4 2 System Development Methodology Characterization 94
Table 4 3 Method Selection Approaches [Law 1988, pp. 17] 97
Table 4 4 ISO 9001 Selection Criteria Rating 107
Table 4 5 ISO/DIS 9000 3 Selection Criteria Rating 107
Table 4 6 TickIT Selection Criteria Rating 108
Table 5 1 Formal Quality System Requirements 113
Table 5 2 Quality System Management Requirements 115
Table 5 3 Internal Quality Auditing Requirements 117
Table 5 4 Corrective and Preventive Actions Requirements 118
Table 5 5 Quality System Cross Reference 122
Table 6 0 V Model Life Cycle Deliverables 124
Table 6 1 Contract Review Requirements 127
Table 6 2 GAMP Requirements Definition Requirements 130
Table 6 3 Life Cycle Model Requirements 135
Table 6 4 Project Planning Requirements 137
Table 6 5 Quality Planning Requirements 140
Table 6 6 Suggesting a Quality Plan Structure 141
Table 6 7 Test Planning Requirements 143
Table 6 8 Test Activities in Life Cycle Phases [IEEE Std 1059 1993,p. 13] 145
Table 6 9 Test Plan [Hambloch 1994a, p. 148] 145
Table 6 10 Risk Assessment Requirements 150
Table 6 11 Development Output Requirements 154
Table 6 12 Development Review Requirements 159
Table 6 13 Levels of Testing [IEEE Std 1059 1993 ,pl3] 164
Table 6 14 In Process Testing Requirements 166
Table 6 15 Acceptance Requirements 170
Table 6 16 Replication, Delivery and Installation Requirements I73
of Content ix
Table 6 17 Maintenance Requirements 176
Table 7 1 Configuration Management Requirements 183
Table 7 2 Document Control Requirements 187
Table 7 3 Quality Records 189
Table 7 4 Statistical Techniques Requirements 192
Table 7 5 CMM Key Process Areas [SEI1993, p 27] 194
Table 7 6 Tool Control Requirements 197
Table 7 7 Sub Contractor Control Requirements 200
Table 7 8 Included Products Requirements 204
Table 7 9 Supplier Training Requirements 206
x Table
List of Figures
Figure 1 1 Stakeholder Analysis 4
Figure 1 2 Efforts Needed for GMP Compliance of Software Development
Life Cycle Phases 6
Figure 1 3 Selecting a Compliance Operating Point [Coopers Lybrand 1996b, p. 3]..7
Figure 1 4 Placing the Thesis in a Conceptual Context 8
Figure 1 5 Quality System Structure [ISO 9004 1:1994, 5.3.2.4] 11
Figure 1 6 Survey Classes Rates of Response 16
Figure 2 1 R D and Facility Costs for Bringing a New Drug to Market in 1993
[Pisanol996,p. 74] 20
Figure 2 2 Manufacturing information flow 24
Figure 2 3 Structure of the EU GMP Regulations [Hambloch 1996] 33
Figure 3 1 Computer Related System [Chapman 1994a, p. 79] 42
Figure 3 2 Basic Client/Server Configurations [Buck Emden/Galimow 1995, p. 21J.44
Figure 3 3 Validation Process for aNew Computerized System 50
Figure 3 4 Relevance of Selected Regulatory Sources for the Implementation of
Quality Systems for the Development of GMP Critical Software 51
Figure 3 5 Relevance of EU Guide Annex 11 for the Implementation of Quality
Systems for the Development of GMP Critical Software 54
Figure 3 6 Overall Suitability of the GMP Guidelines to Address EU and U.S.
Regulatory Requirements for Computer Systems Used in
Pharmaceutical Manufacturing 57
Figure 3 7 Approval Rate of the Applicability of GMP Guidelines to
Pharmaceutical Manufacturers 58
Figure 3 8 Approval Rate of the Applicability of GMP Guidelines to Suppliers of
Computer Systems to the Pharmaceutical Industry 59
Figure 3 9 Suitability of GAMP Regarding the Addressing of EU and U. S. GMP
Requirements for Computerized Systems 60
Figure 3 10 Approval Rate of the Suitability of GMP Guidelines to be Used as
Contractual Requirements for the Acquisition of Computer Systems 71
Figure 4 1 Current Understanding of Quality 74
Figure 4 2 Perceived relative importance of software problems in european
companies [Rempp 1996, p. 13] 77
Figure 4 3 Overall Suitability of Certified Quality Systems to Support the
Development of Validated Computer Systems 79
Figure 4 4 ISO Quality System Decision Framework 81
of Content xi
Figure 4 5 Suitability of ISO 9001 to Support the Development of a Validated
Computer System 82
Figure 4 6 Suitability of ISO 9001 in Combination with ISO 9000 3 to Support the
Development of a Validated Computer System 84
Figure 4 7 Suitability of TicldT to Support the Development of a Validated
Computer System 86
Figure 4 8 Supplier Assessment Maturity Scale [based on Bratt 1996] 88
Figure 4 9 Suitability of Selected Development Methodologies to support GMP
Compliance of Computer Systems Effectively 93
Figure 4 10 ABAP/4 Development Workbench [Buck Emden/Galimow 1995,
p. 121] 95
Figure 4 11 Structure of ISO 12207:1995 [ISO 12207:1995, p. 7] 99
Figure 4 12 The Royce Waterfall Life Cycle Model [Royce 1970] 101
Figure 4 13 Specification and Testing [GAMP 1996, p. 19] 102
Figure 4 14 Suitability Rating of the V Model Regarding its Support of GMP
Compliance of Computer Systems Used in Pharmaceutical
Manufacturing 103
Figure 4 15 The V model Levels of Standardization [IABG 1995a, p. 2] 103
Figure 4 16 Interaction of the Sub Models [IABG 1995a, p. 7] 104
Figure 5 1 Integrated Software Development Environment Solution 112
Figure 6 0 The V Model System Development Life Cycle [V Model 1992,
p. 2 12] 123
Figure 6 1 Requirements Specification Process 126
Figure 6 2 Software Development Planning Concept 133
Figure 6 3 Test Documents [IEEE Std 829 1983, p. 5] 147
Figure 6 4 Software Verification Structure 158
Figure 7 1 Configuration Identification Process [IEEE Std 828 1990, p. 9] 179
Figure 7 2 Model of Change Management [IEEE Std 1042 1987,p 12] 180
Figure 7 3 Product Flow in Sub Model CM [V Model 1992a, p. 6 2] 184
Figure 7 4 Process Assessment Model [ISO 1996b] 191
Figure 7 5 Maturity Framework: Five Levels [SEI 1993,p 17] 193
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| indexdate | 2024-07-09T18:13:10Z |
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| spelling | Hefti, Thomas Verfasser aut Quality system model for development and maintenance of software in pharmaceutical manufacturing von Thomas Hefti 1997 Getr. Zählung graph. Darst. txt rdacontent n rdamedia nc rdacarrier St. Gallen, Univ., Diss., 1997 Softwareentwicklung (DE-588)4116522-6 gnd rswk-swf Qualitätsmanagement (DE-588)4219057-5 gnd rswk-swf Pharmazeutische Industrie (DE-588)4045696-1 gnd rswk-swf (DE-588)4113937-9 Hochschulschrift gnd-content Pharmazeutische Industrie (DE-588)4045696-1 s Softwareentwicklung (DE-588)4116522-6 s Qualitätsmanagement (DE-588)4219057-5 s DE-604 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=007841663&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Hefti, Thomas Quality system model for development and maintenance of software in pharmaceutical manufacturing Softwareentwicklung (DE-588)4116522-6 gnd Qualitätsmanagement (DE-588)4219057-5 gnd Pharmazeutische Industrie (DE-588)4045696-1 gnd |
| subject_GND | (DE-588)4116522-6 (DE-588)4219057-5 (DE-588)4045696-1 (DE-588)4113937-9 |
| title | Quality system model for development and maintenance of software in pharmaceutical manufacturing |
| title_auth | Quality system model for development and maintenance of software in pharmaceutical manufacturing |
| title_exact_search | Quality system model for development and maintenance of software in pharmaceutical manufacturing |
| title_full | Quality system model for development and maintenance of software in pharmaceutical manufacturing von Thomas Hefti |
| title_fullStr | Quality system model for development and maintenance of software in pharmaceutical manufacturing von Thomas Hefti |
| title_full_unstemmed | Quality system model for development and maintenance of software in pharmaceutical manufacturing von Thomas Hefti |
| title_short | Quality system model for development and maintenance of software in pharmaceutical manufacturing |
| title_sort | quality system model for development and maintenance of software in pharmaceutical manufacturing |
| topic | Softwareentwicklung (DE-588)4116522-6 gnd Qualitätsmanagement (DE-588)4219057-5 gnd Pharmazeutische Industrie (DE-588)4045696-1 gnd |
| topic_facet | Softwareentwicklung Qualitätsmanagement Pharmazeutische Industrie Hochschulschrift |
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