ispe baseline toc

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ISPE Baseline® Guide: Page 7

Oral Solid Dosage Forms

Table of Contents

1 Introduction ........................................................................................................................11

1.1 Background ................................................................................................................................................ 11 1.2 Scope of this Guide....................................................................................................................................12

1.3 Key Features of this Guide ........................................................................................................................ 12

1.4 How to Use this Guide ...............................................................................................................................14

2 Concepts and Regulatory Philosophy ............................................................................ 17

2.1 Introduction ................................................................................................................................................17

2.2 Regulatory Philosophy ...............................................................................................................................17

2.3 Science-Based Quality Risk Management.................................................................................................19

2.4 Risk Management Approach ...................................................................................................................... 19

2.5 Principles of Risk Management for OSD Facilities ....................................................................................20

2.6 Quality Risk Management Process for OSD Facilities ...............................................................................21

3 Product Protection............................................................................................................ 23 3.1 Potential Product Protection Requirements ...............................................................................................23

3.2 Design Concepts for Product Protection ....................................................................................................27

3.3 Process Control Concepts .........................................................................................................................29

4 Product and Processing .................................................................................................. 31 4.1 Introduction ................................................................................................................................................31

4.2 Preliminary Design Considerations ............................................................................................................ 31

4.3 Impact of Powder Physical and Chemical Properties on Equipment Design ............................................. 32

4.4 General Equipment Considerations ........................................................................................................... 35

4.5 Overview of Isolation and Containment Technology ..................................................................................42

4.6 Architectural and Facility Interface Considerations ....................................................................................43

4.7 Material Handling .......................................................................................................................................43

4.8 Process Unit Operations ............................................................................................................................46

4.9 Materials Handling and Storage.................................................................................................................64

4.10 Process Utilities .........................................................................................................................................64

4.11 Supporting Unit Operations........................................................................................................................64

4.12 Considerations for Post-Approval Equipment Changes.............................................................................65

4.13 Emerging Technologies .............................................................................................................................. 65

5 Architectural ...................................................................................................................... 67 5.1 Introduction ................................................................................................................................................67

5.2 High Level Considerations .........................................................................................................................67

5.3 Functional Areas ........................................................................................................................................70

5.4 Layout ........................................................................................................................................................75

5.5 Surface Finishes and Materials of Construction ........................................................................................ 81 5.6 Other Considerations .................................................................................................................................86

6 Process Support and Utilities .......................................................................................... 89 6.1 Introduction ................................................................................................................................................89

6.2 Approach....................................................................................................................................................89

6.3 OSD Process Support Systems and Utilities .............................................................................................89

6.4 Supporting Management Systems ............................................................................................................. 95

ISPE BG: OSD2 – TOC ©2009 ISPE. All rights reserved. www.ISPE.org



Page 8 ISPE Baseline® Guide:


7 HVAC .................................................................................................................................. 97 7.1 Introduction ................................................................................................................................................97

7.2 HVAC Description ......................................................................................................................................97

7.3 Environmental Standards and GMP ..........................................................................................................98

7.4 Design Considerations .............................................................................................................................100 7.5 Non-GMP Considerations ........................................................................................................................ 105

7.6 Room Air Systems ...................................................................................................................................109

7.7 Commissioning and Qualication Consideration ..................................................................................... 112

7.8 Life Cycle Cost Considerations ................................................................................................................ 112

7.9 Cleaning and Maintenance of HVAC Systems ......................................................................................... 113

8 Electrical ...........................................................................................................................115 8.1 Introduction .............................................................................................................................................. 115

8.2 Power Distribution Overview .................................................................................................................... 115

8.3 Electrically Classied Areas ..................................................................................................................... 117

8.4 Identication and Labeling ....................................................................................................................... 117

8.5 Lighting .................................................................................................................................................... 118

8.6 Wiring Methods ........................................................................................................................................ 118 8.7 Motors and Drives .................................................................................................................................... 119

8.8 Grounding ................................................................................................................................................ 119

8.9 Preventive Maintenance ..........................................................................................................................120

9 Control and Instrumentation.......................................................................................... 121 9.1 Introduction ..............................................................................................................................................121

9.2 Monitoring and Control.............................................................................................................................122

9.3 Validation ................................................................................................................................................. 124

10 Other Considerations ..................................................................................................... 125 10.1 Introduction and Non-CGMP Risk Considerations ...................................................................................125

10.2 Strategies to Control Employee Exposures to Hazardous Materials ....................................................... 125

10.3 Preventing Physical Injury and Life Safety...............................................................................................137

10.4 Hazardous Operations .............................................................................................................................142

10.5 Environmental ..........................................................................................................................................146

10.6 Community Response and Emergency Preparedness ............................................................................ 148

10.7 Controlled Substances .............................................................................................................................148

11 Risk-Based Approaches to Commissioning and Qualifcation .................................. 149 11.1 Introduction .............................................................................................................................................. 149

11.2 Principles and Concepts of ASTM E2500 ................................................................................................ 149

12 Appendix 1 – Cost Factors in OSD Manufacturing ...................................................... 153 12.1 Introduction ..............................................................................................................................................153

12.2 Life Cycle Costing ....................................................................................................................................153

12.3 Cost Drivers ............................................................................................................................................. 153

13 Appendix 2 – Summary of Quality Risk Management Process .................................. 157

14 Appendix 3 – Risk Management Tools.......................................................................... 161 14.1 Introduction ..............................................................................................................................................161

14.2 Example Risk Assessment for an OSD Facility Upgrade.........................................................................161




ISPE Baseline® Guide: Page 9


15 Appendix 4 – HSE International Regulations and Standards Cross References ..... 167 15.1 General Regulatory Approach by Region ................................................................................................ 167

15.2 Containment and Employee Exposure ....................................................................................................168

15.3 Preventing Personal Injury ....................................................................................................................... 169

15.4 Hazardous Operations .............................................................................................................................170 15.5 Environmental Protection .........................................................................................................................171

15.6 Emergency Preparedness ....................................................................................................................... 173

15.7 Controlled Substances .............................................................................................................................173

15.8 Japanese Laws and Regulations ............................................................................................................. 173

16 Appendix 5 – References ............................................................................................... 175

17 Appendix 6 – Glossary ................................................................................................... 179 17.1 Abbreviations ...........................................................................................................................................179

17.2 Acronyms .................................................................................................................................................180

17.3 Denitions ................................................................................................................................................182


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