ISPE Baseline® Guide: Page 5

Commissioning and Qualification

Table of Contents
1 Introduction...................................................................................................................... 9
1.1 Background................................................................................................................................................... 9
1.2 Purpose and Objectives................................................................................................................................ 9
1.3 Scope.......................................................................................................................................................... 10
1.4 Process Overview and Structure of the Guide............................................................................................ 11
1.5 Rationale for this Second Edition................................................................................................................ 14
1.6 Key Concepts............................................................................................................................................. 14
1.7 Key Terms................................................................................................................................................... 15

2 User Requirements Specification................................................................................. 19

2.1 Introduction................................................................................................................................................. 19
2.2 Development of the User Requirements Specification............................................................................... 20
2.3 Approval of User Requirements Specification and Changes Post-Approval.............................................. 22
2.4 Legacy Systems.......................................................................................................................................... 22

3 System Classification..................................................................................................... 23
3.1 Introduction................................................................................................................................................. 23
3.2 System Boundaries..................................................................................................................................... 23
3.3 Criteria for System Classification................................................................................................................ 24

4 System Risk Assessment............................................................................................... 27

4.1 Introduction................................................................................................................................................. 27
4.2 System Risk Assessment Process.............................................................................................................. 29
4.3 Timing of System Risk Assessments.......................................................................................................... 31
4.4 Example System Risk Assessment Format................................................................................................ 33

5 Design Review and Design Qualification.................................................................... 35

5.1 Introduction................................................................................................................................................. 35
5.2 Design Process........................................................................................................................................... 35
5.3 Design Review............................................................................................................................................ 36
5.4 Design Qualification.................................................................................................................................... 38
5.5 Timing of Design Review and Design Qualification.................................................................................... 40

6 C&Q Planning................................................................................................................... 41
6.1 Introduction................................................................................................................................................. 41
6.2
6.3
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C&Q Planning Approach............................................................................................................................. 42
C&Q Plan.................................................................................................................................................... 44
6.4 Example Approval Matrix............................................................................................................................ 47

7
Dr. Fearghal Downey
C&Q Testing and Documentation................................................................................ 49
7.1 Cork,
Introduction................................................................................................................................................. 49
7.2 Prerequisites............................................................................................................................................... 52
7.3 ID number: 284828
Execution.................................................................................................................................................... 53
7.4 Discrepancy Management.......................................................................................................................... 59

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Page 6 ISPE Baseline® Guide:
Commissioning and Qualification

8 Acceptance and Release................................................................................................ 61

8.1 Introduction................................................................................................................................................. 61
8.2 Prerequisites for the Acceptance and Release Phase................................................................................ 61
8.3 Requirements to Complete the Acceptance and Release Phase............................................................... 61
8.4 Summary Report Organization................................................................................................................... 63
8.5 Acceptance and Release Completion......................................................................................................... 67
8.6 Traceability Matrix....................................................................................................................................... 67

9 Periodic Review.............................................................................................................. 69
9.1 Introduction................................................................................................................................................. 69
9.2 Periodic Review Approach.......................................................................................................................... 72
9.3 Phase 1: System Categorization and Schedule Assignment...................................................................... 73
9.4 Phase 2: Periodic Review Execution.......................................................................................................... 75

10 Vendor Assessment for C&Q Documentation Purposes........................................... 79

10.1 Introduction................................................................................................................................................. 79
10.2 Communication of Requirements, Scope, and Deliverables...................................................................... 80
10.3 Vendor Assessment Factors....................................................................................................................... 80
10.4 Vendor Assessment Strategy...................................................................................................................... 81
10.5 Use of Vendors Unfamiliar with GMP.......................................................................................................... 82
10.6 Vendor Training........................................................................................................................................... 82

11 Engineering Quality Process........................................................................................ 83

11.1 Introduction................................................................................................................................................. 83
11.2 Application.................................................................................................................................................. 84
11.3 Deliverables................................................................................................................................................ 86
11.4 Roles and Responsibilities.......................................................................................................................... 87

12 Change Management..................................................................................................... 89
12.1 Introduction................................................................................................................................................. 89
12.2 Engineering Change Management............................................................................................................. 91
12.3 Change Management during C&Q Projects............................................................................................... 92
12.4 Change Management during Operation..................................................................................................... 93
12.5 Engineering Change Management Process............................................................................................... 93

13 Good Documentation Practice for C&Q...................................................................... 97

13.1 Introduction................................................................................................................................................. 97
13.2 C&Q Document Development Basics......................................................................................................... 98
13.3
13.4
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Document Execution................................................................................................................................... 99
Attachments and Supporting Documentation........................................................................................... 102
13.5 Corrections................................................................................................................................................ 102
13.6 Document Review and Approval............................................................................................................... 103
13.7 Dr. Fearghal Downey
Storage, Retrieval, and Retention of Documents..................................................................................... 103
13.8 Disaster Recovery..................................................................................................................................... 103
Cork,
14 ID number:
Strategies for Implementation 284828
of Science and Risk-Based C&Q Process............105
14.1 Introduction............................................................................................................................................... 105
14.2 Preparing for Implementation................................................................................................................... 107
14.3 Downloaded on: 8/12/19 7:45 AM
Approaches for Implementation................................................................................................................ 108

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ISPE Baseline® Guide: Page 7
Commissioning and Qualification

15 Appendix 1 – Regulatory Basis..................................................................................... 111

15.1 Chapter 1: Introduction..............................................................................................................................111
15.2 Chapter 2: User Requirements Specification............................................................................................ 112
15.3 Chapter 3: System Classification.............................................................................................................. 113
15.4 Chapter 4: System Risk Assessments...................................................................................................... 113
15.5 Chapter 5: Design Review and Design Qualification................................................................................ 114
15.6 Chapter 6: C&Q Planning......................................................................................................................... 115
15.7 Chapter 7: C&Q Testing and Documentation............................................................................................ 116
15.8 Chapter 8: Acceptance and Release........................................................................................................ 118
15.9 Chapter 9: Periodic Review...................................................................................................................... 119
15.10 Chapter 10: Vendor Assessments for C&Q Documentation Purposes..................................................... 119
15.11 Chapter 11: Engineering Quality Process................................................................................................. 120
15.12 Chapter 12: Change Management........................................................................................................... 120
15.13 Chapter 13: Good Documentation Practices for C&Q.............................................................................. 121
15.14 Chapter 14: Implementation of Science and Risk-Based C&Q Process.................................................. 121

16 Appendix 2 – User Requirements Specification Example....................................... 123

17 Appendix 3 – System Classification Form Example................................................. 133

18 Appendix 4 – Direct Impact System Examples......................................................... 135

19 Appendix 5 – System Risk Assessment Example..................................................... 141

20 Appendix 6 – Design Review/Design Qualification Examples...............................145

20.1 Design Review for Equipment.................................................................................................................. 145
20.2 Design Review for Facilities...................................................................................................................... 149
20.3 Design Qualification Summary................................................................................................................. 157

21 Appendix 7 – Supporting Plans...................................................................................159

22 Appendix 8 – System Start-Up Examples...................................................................161

22.1 System Pre-Start-Up Checklist................................................................................................................. 161
22.2 Energizing the System.............................................................................................................................. 162
22.3 Pre-Functional Testing Checklist............................................................................................................... 163

23 Appendix 9 – Discrepancy Form Example................................................................165

24.1
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24 Appendix 10 – Qualification Summary Report Examples.......................................167
Qualification Summary Report – Form..................................................................................................... 167
24.2 Qualification Summary Report – Detailed................................................................................................. 168

Dr. Fearghal Downey

25 Appendix 11 – Periodic Review Example....................................................................171
Cork,
26 Appendix 12 – Periodic Review for Controlled Temperature Chambers.............. 175
IDandnumber:
26.1 Assignment of Categories 284828
Periodic Review Schedule Requirements............................................... 175
26.2 Periodic Review Assessment.................................................................................................................... 177
26.3 Periodic Review Report Template............................................................................................................. 177
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27 Appendix 13 – Vendor Assessment Tool Example.................................................... 183

28 Appendix 14 – Organizational Maturity Assessment Example...............................185

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