How to develop and manage qualification protocols for FDA compliance

Contents......Page 3
Preface......Page 8
Organization......Page 10
Validation Elements......Page 12
Validation Documentation......Page 13
Basic Protocol Documentation Steps......Page 14
Protocol Writing......Page 15
How to Use This Book......Page 16
Equipment Master List......Page 17
Equipment Numbering System......Page 18
Equipment Description......Page 19
Complete Equipment Master List......Page 20
Protocol Master List......Page 22
Protocol Master List Preparation......Page 24
Qualification and Requalification Protocol Numbering Structure......Page 26
Protocol Number Assignment......Page 27
Request for Validation Form......Page 28
Request for Validation Form Preparation......Page 30
Request for Validation Form Number Assignment......Page 31
3. Protocol Format and Style Guide......Page 32
Qualification Protocol—Page 1......Page 33
Qualification Protocol—Page 1 Preparation......Page 34
Qualification Protocol—Page 2 Preparation......Page 35
Complete Equipment Qualification Protocol......Page 37
Reference Documentation......Page 59
Protocol Writing Tips......Page 64
Installation Qualification......Page 65
Operational Qualification......Page 66
Document Review and Approval......Page 67
Outside Department Review and Approval......Page 68
Document Review Form......Page 69
Document Review Form Preparation......Page 70
Project Status List......Page 72
Qualification Testing......Page 75
What Level of Testing Is Required?......Page 76
Final Report......Page 77
Final Report Form......Page 78
Final Report—Page 2 Preparation......Page 80
Completed Final Report......Page 82
Conditional Release......Page 84
System Certification......Page 86
Validation Release Tag......Page 89
Baseline Management......Page 92
Validation Baseline Document......Page 93
Validation Baseline Document—Page 1 Preparation......Page 94
Validation Baseline Document—Page 2 Preparation......Page 95
Validation Baseline Document Number Assignment......Page 96
Change Control System......Page 97
Reasons for Changes......Page 99
Validation Change Request Form......Page 100
Changes Before, During, and After Qualification Testing......Page 103
Deficiency......Page 105
Deficiency Form Preparation......Page 106
Addendum......Page 107
Addendum—Page 2......Page 109
Addendum Number Assignment......Page 112
Reasons for Requalification......Page 115
Requalification Approach......Page 116
Requal Protocol......Page 117
Requal Protocol—Page 1 Preparation......Page 118
Requal Protocol—Page 2 Preparation......Page 119
Completed Equipment Requal Protocol......Page 120
Protocol Package Contents Sheet......Page 130
Protocol Package Contents Sheet Preparation......Page 131
Block Number Assignment......Page 133
Equipment Number Assignment Log......Page 135
Protocol Number Assignment Log......Page 137
Protocol Number Assignment Log Preparation......Page 141
Document Review Form Number Assignment Log Preparation......Page 149
Final Report Number Assignment Log......Page 150
Final Report Number Assignment Log Preparation......Page 151
Certification Form Number Assignment Log Preparation......Page 153
Validation Baseline Document Number Assignment Log......Page 154
Validation Baseline Document Number Assignment Log Preparation......Page 155
Deficiency Form Number Assignment Log Preparation......Page 157
Addendum Number Assignment Log......Page 158
Addendum Number Assignment Log Preparation......Page 159
Form Number Assignment Log Preparation......Page 161
Forms Control......Page 165
Prefix......Page 169
Suffix......Page 170
Associated Documentation Numbers......Page 171
Protocol Names......Page 172
Document Database......Page 173
Document Database Preparation......Page 175
A. Cleaning Qualification Protocol Example......Page 177
B. Facilities Qualification Protocol Example......Page 185
C. Utilities Qualification Protocol Example......Page 206
D. Equipment Qualification Protocol Example......Page 236
E. Computer Qualification Protocol Example......Page 265
F. Process Qualification Protocol Example......Page 328
G. Full-Size Lists and Forms......Page 347
H. Abbreviations......Page 362
I. Glossary......Page 364
J. Recommended Reading......Page 366
C......Page 367
F......Page 368
P......Page 369
Q......Page 370
V......Page 371