Validation of Pharmaceutical Processes

Front Cover
James P. Agalloco, Frederick J. Carleton
CRC Press, Sep 25, 2007 - Medical - 760 pages
Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va
 

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Contents

Chapter 2 Organizing for Validation
5
Chapter 3 Validation and Facility Design
11
Support and Utility Systems
27
Chapter 5 Validation of Critical Utilities
51
Chapter 6 The Validation of Pharmaceutical Water Systems
59
Chapter 7 Caliberation and Metrology
99
Chapter 8 Temeprature Meaurements
109
Chapter 9 Qualification and Change Control
129
Chapter 31 Validation of OralTopical Liquids and Semisolids
417
Chapter 32 Validation of Packaging Operations
429
Primary Manufacturing
443
Chapter 34 Validation of Recovery and Purification Processes
455
Chapter 35 Validation of Process Chromatography
473
Chapter 36 Cell Culture Process Validation
481
Manufacturing Related Activities
491
Chapter 38 Validation of Training
519

Sterilization Sanitization and Sterility Assurance
147
Chapter 11 FD and z Values
159
Chapter 12 Steam Sterilization in Autoclaves
175
Chapter 13 Validation of Terminal Sterilization
187
Chapter 14 Steam SterilizationinPlace Technology and Validation
201
Chapter 15 Dry Heat Sterilization and Depyrogenation Validation and Monitoring
223
Chapter 16 Validation of Ethylene Oxide Sterilization Processes
241
Chapter 17 Validation of Chlorine Dioxide Sterilization
263
Chapter 18 Validation of the Radiation Sterilization of Pharmaceuticals
269
Chapter 19 Isolator Decontamination
277
Chapter 20 Validation of SterilizingGrade Filters
287
Chapter 21 Cleaning and Disinfection in the Control of Pharmaceutical Cleanrooms
303
Organization and Validation
317
Chapter 23 Validation of Aspectic Processing for Bulk Pharmaceutical Chemicals
327
Chapter 24 Validation of Manual Aseptic Processes
333
Sterile Product Manufacturing
339
Chapter 26 Viable Environmental Microbiological Monitoring
357
Chapter 27 Validation of Container Preparation Processes
371
Chapter 28 Validation of Lyophilization
381
Chapter 29 Qualifaction Concerns for Isolator Systems
399
Secondary Manufacturing
403
Chapter 39 Vendor Qualification and Validation
529
Chapter 41 Validation of New Products
549
Chapter 42 Retrospective Validation
555
Chapter 43 Validation and Six Sigma
565
Chapter 44 Validation and Contract Manufacturing
571
Computerized Systems
583
Chapter 46 Computerized Systems Validation
607
Chapter 47 Validation of Control Systems
619
Chapter 48 RiskBased Validation of a Laboratory Information Management System
629
Chapter 49 Validation of Laboratory Information Systems
641
Laboratory Methods and Quality Assurance
655
Chapter 51 Validation of Microbiological Methods
665
General Topics
671
Chapter 53 The European Approach to ValidationA Microbiological Perspective
677
Chapter 54 Japanese Regulatory Requirements
683
Chapter 55 Managing Validation in a Multinational Company
695
Chapter 56 Validation in a Small Pharmaceutical Company
703
Chapter 57 Regulatory Aspects of Validation
709
Chapter 58 ValidationWhats Next?
715
Back cover
743
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