Validation of Pharmaceutical ProcessesJames P. Agalloco, Frederick J. Carleton 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 |
Contents
Introduction | 1 |
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 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 |
Chapter 9 Qualification and Change Control | 129 |
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 |
| 719 | |
Back cover | 743 |
Other editions - View all
Validation of Pharmaceutical Processes, Third Edition James P. Agalloco,Frederick J. Carleton No preview available - 2007 |
Common terms and phrases
acceptable activities additional agents applied approach appropriate aseptic processing associated assurance batch calibration cell challenge chapter cleaning completed components concentration conducted considered consistent containers critical cycle defined demonstrate dependent determine devices disinfection documentation drug effect ensure environment equipment established evaluation example facility Figure filter final flow function heat important increase indicated industry inspection installation integrity isolator limits liquid load locations manufacturing materials measured ment methods microbial microorganisms monitoring necessary operation organisms parameters particle performed personnel pharmaceutical phase practice preparation present pressure procedures protocol qualification range reference removal residual resistance sampling selected solution specific spore standard steam step sterilization studies surface Table temperature testing typically unit usually utilized validation verify