Pharmaceutical Engineering Change Control

Pharmaceutical Engineering Change Control......Page 1
Dedication......Page 4
Foreword......Page 5
Preface......Page 7
References......Page 9
Acknowledgments......Page 10
The Editor......Page 11
Contributors......Page 12
Table of Contents......Page 13
CONTENTS......Page 14
II. The Economics......Page 15
A. Concept of current Good Manufacturing Practice  cGMP......Page 17
V. Changes in Safety Practices......Page 18
B. Changes in Data and Design Codes......Page 19
VI. Changes during Design......Page 20
A. Morality, Codes of Ethics, and Government Policy......Page 21
C. Public Pressure......Page 22
A. Results of Research and Development......Page 23
XI. Date- Related Functions......Page 24
References......Page 25
CONTENTS......Page 27
A. Globalization Requires Regulatory Affairs Integration in the Change Control System......Page 28
B. Other Considerations......Page 32
C. Relief in the Form of Harmonization......Page 33
III. Current Regulations and Guidance for Evaluating and Reporting Manufacturing Changes to the FDA......Page 34
B. SUPAC: CDER Guidance Documents for Specific Drug Product Dosage Forms......Page 35
1. SUPAC-IR: Immediate Release Dosage Forms......Page 36
2. SUPAC-MR: Modified Release Dosage Forms......Page 37
3. SUPAC-SS: Nonsterile Semisolid Dosage Forms......Page 38
C. BACPAC: Bulk Active Chemical  Pharmaceutical Ingredient Postapproval Changes......Page 39
E. FDAMA and Manufacturing Changes......Page 41
G. Manufacturing Changes for Biologics......Page 43
IV. Moving Forward in Managing Change......Page 45
References......Page 46
CONTENTS......Page 48
II. Brief History and Recent Developments......Page 49
V. Future Changes ? The Increasing Scope of GMP......Page 50
VII. Transmissible Spongiform Encephalopathy  TSE and Regulatory Controls......Page 51
VIII. Manufacturer\'s Licenses......Page 52
C. Site Master Files  SMFs......Page 53
B. Changes to Sterile Areas......Page 54
D. Changes to Computer Systems......Page 55
1. Controlling Compliance......Page 56
1. Corporate Audits......Page 57
5. GMP Audits......Page 58
References......Page 60
I. Introduction......Page 61
II. Control Requires Documentation......Page 63
IV. One System for All......Page 64
V. Permit- to- Work System......Page 65
VI. Traceability......Page 69
A. Cost......Page 70
E. Initiative......Page 71
I. Automation......Page 72
VIII. Documentation Changes......Page 73
IX. Auditing the Change Control System......Page 76
X. Summary......Page 77
CONTENTS......Page 78
II. Background......Page 79
A. Capture the Intent to Change......Page 80
B. Evaluate the Effects of the Change......Page 81
C. Authorizing the Change......Page 84
D. Recording the Change and the New Status......Page 85
A. Equivalence......Page 87
B. Design Improvement......Page 88
C. Minor Project......Page 89
V. Pitfalls and Problems......Page 91
B. The Midnight Breakdown......Page 94
VI. The Change Control Forms......Page 95
A. Engineering Change Request  Figure 5.1......Page 96
D. Plant Design Approval and HAZOP Form  Figure 5.6......Page 97
VII. Administration and Auditing......Page 100
VIII. Conclusions......Page 101
CONTENTS......Page 102
III. Change Control ? Basics......Page 103
IV. Computer System Elements and the Operating Environment......Page 104
A. Some Serious Incidents That Have Occurred during the Use of Computer Systems......Page 105
B. Pharmaceutical Industry Failures......Page 106
3. Being Clear about the Main Protection Guarding Against the Risk......Page 107
5. Computer Failures Can Be Share Price Sensitive......Page 108
VII. What Can Go Wrong......Page 109
A. GDP......Page 111
B. GEP......Page 112
C. Configuration Management......Page 113
VIII. Auditing Computer Systems......Page 114
References......Page 115
Appendix 6.1: Example Procedure for Computer System Change Control......Page 116
3.3 Change Disposition and Authorization......Page 117
3.4 Change Completion and Approval......Page 118
Appendix 6.2: Example Procedure for Computer System  Document Control......Page 122
3.3 Document Issue......Page 123
3.5 Document Changes......Page 124
References......Page 125
Appendix 6.3: Example Procedure for Computer System Threats and Controls Review......Page 127
3.1 Planning......Page 128
3.3 Review Checklist......Page 129
CONTENTS......Page 131
II. Explosion in a New Solvent Tank......Page 132
III. Washing, Cleaning, Sterilizing, and Purging Operations......Page 133
IV. Vessel Agitator Position Modification......Page 134
V. Room Collapse during Commissioning......Page 135
VI. Autoclave Upgrade......Page 136
VII. Lactose ? California vs. Wisconsin......Page 137
VIII. Asthma Inhaler Cartridges Scrapped......Page 138
IX. Increase in Demand on Site Steam......Page 139
X. Uncontrolled Drawing......Page 140
XI. Plant Labeling Inconsistency......Page 142
XIII. Batch Records Inaccurate......Page 143
XIV. Gardener\'s Hut......Page 144
XV. The Effect of Process Tweaks over Time......Page 145
XVI. Climb in Product Yield......Page 146
XVII. Change to Emergency Exit Could Have Been Disastrous......Page 147
XVIII. Water for Injection System Contamination......Page 149
XX. Drain Valve Opened by Mistake......Page 150
XXI. Increase in Compressed Air Capacity......Page 151
XXIV. The Great Cranberry Scare......Page 152
\" That\'s Not My Job\"......Page 153
References......Page 154
CONTENTS......Page 156
A. Project Attributes......Page 157
B. Attributes of Successful Projects......Page 158
III. Project Change Control Procedure ? What Should It Cover?......Page 159
B. Responsibilities......Page 160
3. Feedback to Change Flag Originator Û Approval Notification......Page 162
4. Change Review and Evaluation......Page 163
D. Standard Forms......Page 164
A. Instructions Coming Directly from Customer and Client Organization Are Implemented without Review and Approval by Project Management......Page 168
E. Losing Track of Technical Developments to Engineering Deliverables in between Formal Issues......Page 169
Reference......Page 171
Glossary......Page 172
List of Abbreviations......Page 176