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ISPE Baseline® Guide:
Oral Solid Dosage Forms
Table of Contents
1
2
3
4
5
6
Introduction.........................................................................................................................11
1.1
1.2
1.3
1.4
Background................................................................................................................................................. 11
Scope of this Guide.................................................................................................................................... 12
Key Features of this Guide......................................................................................................................... 12
How to Use this Guide................................................................................................................................ 14
Concepts and Regulatory Philosophy............................................................................. 17
2.1
2.2
2.3
2.4
2.5
2.6
Introduction................................................................................................................................................. 17
Regulatory Philosophy................................................................................................................................ 17
Science-Based Quality Risk Management................................................................................................. 19
Risk Management Approach....................................................................................................................... 19
Principles of Risk Management for OSD Facilities..................................................................................... 20
Quality Risk Management Process for OSD Facilities................................................................................ 21
Product Protection............................................................................................................ 23
3.1 Potential Product Protection Requirements................................................................................................ 23
3.2 Design Concepts for Product Protection..................................................................................................... 27
3.3 Process Control Concepts.......................................................................................................................... 29
Product and Processing................................................................................................... 31
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
4.9
4.10
4.11
4.12
4.13
Introduction................................................................................................................................................. 31
Preliminary Design Considerations............................................................................................................. 31
Impact of Powder Physical and Chemical Properties on Equipment Design.............................................. 32
General Equipment Considerations............................................................................................................ 35
Overview of Isolation and Containment Technology................................................................................... 42
Architectural and Facility Interface Considerations..................................................................................... 43
Material Handling........................................................................................................................................ 43
Process Unit Operations............................................................................................................................. 46
Materials Handling and Storage................................................................................................................. 64
Process Utilities.......................................................................................................................................... 64
Supporting Unit Operations........................................................................................................................ 64
Considerations for Post-Approval Equipment Changes............................................................................. 65
Emerging Technologies............................................................................................................................... 65
Architectural....................................................................................................................... 67
5.1
5.2
5.3
5.4
5.5
5.6
Introduction................................................................................................................................................. 67
High Level Considerations.......................................................................................................................... 67
Functional Areas......................................................................................................................................... 70
Layout......................................................................................................................................................... 75
Surface Finishes and Materials of Construction......................................................................................... 81
Other Considerations.................................................................................................................................. 86
Process Support and Utilities........................................................................................... 89
6.1
6.2
6.3
6.4
Introduction................................................................................................................................................. 89
Approach.................................................................................................................................................... 89
OSD Process Support Systems and Utilities.............................................................................................. 89
Supporting Management Systems.............................................................................................................. 95
ISPE BG: OSD2 – TOC
©2009 ISPE. All rights reserved.
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ISPE Baseline® Guide:
Oral Solid Dosage Forms
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10 Other Considerations...................................................................................................... 125
11 Risk-Based Approaches to Commissioning and Qualification................................... 149
12 Appendix 1 – Cost Factors in OSD Manufacturing....................................................... 153
13 Appendix 2 – Summary of Quality Risk Management Process................................... 157
14 Appendix 3 – Risk Management Tools........................................................................... 161
HVAC................................................................................................................................... 97
7.1
7.2
7.3
7.4
7.5
7.6
7.7
7.8
7.9
Introduction................................................................................................................................................. 97
HVAC Description....................................................................................................................................... 97
Environmental Standards and GMP........................................................................................................... 98
Design Considerations.............................................................................................................................. 100
Non-GMP Considerations......................................................................................................................... 105
Room Air Systems.................................................................................................................................... 109
Commissioning and Qualification Consideration...................................................................................... 112
Life Cycle Cost Considerations................................................................................................................. 112
Cleaning and Maintenance of HVAC Systems.......................................................................................... 113
Electrical............................................................................................................................115
8.1
8.2
8.3
8.4
8.5
8.6
8.7
8.8
8.9
Introduction............................................................................................................................................... 115
Power Distribution Overview..................................................................................................................... 115
Electrically Classified Areas...................................................................................................................... 117
Identification and Labeling........................................................................................................................ 117
Lighting..................................................................................................................................................... 118
Wiring Methods......................................................................................................................................... 118
Motors and Drives..................................................................................................................................... 119
Grounding................................................................................................................................................. 119
Preventive Maintenance........................................................................................................................... 120
Control and Instrumentation.......................................................................................... 121
9.1 Introduction............................................................................................................................................... 121
9.2 Monitoring and Control............................................................................................................................. 122
9.3 Validation.................................................................................................................................................. 124
10.1
10.2
10.3
10.4
10.5
10.6
10.7
Introduction and Non-CGMP Risk Considerations.................................................................................... 125
Strategies to Control Employee Exposures to Hazardous Materials........................................................ 125
Preventing Physical Injury and Life Safety............................................................................................... 137
Hazardous Operations.............................................................................................................................. 142
Environmental........................................................................................................................................... 146
Community Response and Emergency Preparedness............................................................................. 148
Controlled Substances.............................................................................................................................. 148
11.1 Introduction............................................................................................................................................... 149
11.2 Principles and Concepts of ASTM E2500................................................................................................. 149
12.1 Introduction............................................................................................................................................... 153
12.2 Life Cycle Costing..................................................................................................................................... 153
12.3 Cost Drivers.............................................................................................................................................. 153
14.1 Introduction............................................................................................................................................... 161
14.2 Example Risk Assessment for an OSD Facility Upgrade......................................................................... 161
ISPE BG: OSD2 – TOC
©2009 ISPE. All rights reserved.
www.ISPE.org
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ISPE Baseline® Guide:
Oral Solid Dosage Forms
15 Appendix 4 – HSE International Regulations and Standards Cross References...... 167
16 Appendix 5 – References................................................................................................ 175
17 Appendix 6 – Glossary.................................................................................................... 179
15.1
15.2
15.3
15.4
15.5
15.6
15.7
15.8
General Regulatory Approach by Region................................................................................................. 167
Containment and Employee Exposure..................................................................................................... 168
Preventing Personal Injury........................................................................................................................ 169
Hazardous Operations.............................................................................................................................. 170
Environmental Protection.......................................................................................................................... 171
Emergency Preparedness........................................................................................................................ 173
Controlled Substances.............................................................................................................................. 173
Japanese Laws and Regulations.............................................................................................................. 173
17.1 Abbreviations............................................................................................................................................ 179
17.2 Acronyms.................................................................................................................................................. 180
17.3 Definitions................................................................................................................................................. 182
ISPE BG: OSD2 – TOC
©2009 ISPE. All rights reserved.
www.ISPE.org