Pharmaceutical Production - An Engineering Guide

Front Matter......Page 1
Preface......Page 3
List of Acronyms......Page 5
Glossary......Page 10
Table of Contents......Page 0
Table of Contents......Page 20
1. Introduction......Page 24
2.1 Introduction......Page 32
2.2 Key Stages in Drug Approval Process......Page 33
2.3 Example of Requirements......Page 35
2.4 Post-Marketing Evaluation......Page 36
2.6 European and US Regulatory Perspectives......Page 37
3.1 Introduction......Page 40
3.2 GMP Design Requirements......Page 45
3.3 GMP Reviews of Design......Page 57
4.1 Introduction......Page 61
4.2 Preliminary Activities......Page 64
4.3 Validation Master Planning......Page 67
4.4 Development of Qualification Protocols and Reports......Page 74
4.5 Design Qualification (DQ)......Page 76
4.6 Installation Qualification (IQ)......Page 78
4.7 Operational Qualification (OQ)......Page 79
4.8 Handover and Process Optimization......Page 81
4.9 Performance Qualification (PQ)......Page 82
4.10 Process Validation (PV)......Page 83
4.11 Cleaning Validation......Page 84
4.12 Computer System Validation......Page 91
4.14 Change Control and Revalidation......Page 94
5.1 Reaction......Page 98
5.2 Key Unit Operations......Page 108
5.3 Production Methods and Considerations......Page 119
5.4 Principles for Layout of Bulk Production Facilities......Page 123
5.5 Good Manufacturing Practice for BPC......Page 132
6.1 Products and Processes......Page 134
6.2 Principles of Layout and Building Design......Page 177
6.3 The Operating Environment......Page 182
6.4 Containment Issues......Page 199
6.5 Packaging Operations......Page 201
6.6 Warehousing and Materials Handling......Page 212
6.7 Automated Production Systems......Page 214
6.8 Advanced Packaging Technologies......Page 216
7.2 SHE Management......Page 226
7.3 Systems Approach to SHE......Page 231
7.4 Inherent SHE......Page 233
7.5 Risk Assessment......Page 235
7.6 Pharmaceutical Industry SHE Hazards......Page 261
7.7 Safety, Health and Environment Legislation......Page 282
8.1 Introduction......Page 285
8.2 Objectives......Page 286
8.3 Current Good Manufacturing Practice......Page 287
8.4 Design......Page 288
8.5 Utility and Service System Design......Page 295
8.6 Sizing of Systems for Batch Production......Page 312
8.8 Cleaning Systems......Page 314
8.9 Effluent Treatment and Waste Minimization......Page 316
8.10 General Engineering Practice Requirements......Page 322
8.11 Installation......Page 324
8.12 In-House Versus Contractors......Page 325
8.13 Planned and Preventive Maintenance......Page 326
8.14 The Future?......Page 327
9.1 Introduction......Page 329
9.2 Planning a Laboratory......Page 332
9.3 Furniture Design......Page 346
9.4 Fume Cupboards......Page 354
9.5 Extraction Hoods......Page 361
9.7 Fume Extraction......Page 362
9.8 Air Flow Systems......Page 365
9.9 Safety and Containment......Page 369
10.1 Introduction......Page 371
10.3 Process Development......Page 372
10.4 Small-Scale Pilot Facilities......Page 377
10.5 Chemical Synthesis Pilot Plants......Page 386
10.6 Physical Manipulation Pilot Plants......Page 393
10.7 Final Formulation, Filling and Packing Pilot Plants......Page 394
10.11 Commissioning and Validation Management......Page 396
11.1 Introduction......Page 397
11.2 Regulatory, Design and Operating Considerations......Page 398
11.3 Primary Production......Page 414
11.4 Secondary Production......Page 428
11.5 Design of Facilities and Equipment......Page 444
11.6 Process Utilities and Services......Page 469
B......Page 474
C......Page 475
E......Page 476
G......Page 477
L......Page 478
O......Page 479
P......Page 480
R......Page 481
S......Page 482
V......Page 483
W......Page 484