The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.
Preface
v
Contributors
ix
Introduction
xiii
Regulatory Basis for Process Validation
1
(6)
John M. Dietrick
Bernard T. Loftus
Prospective Process Validation
7
(24)
Allen Y. Chao
F. St. John Forbes
Reginald F. Johnson
Paul Von Doehren
Retrospective Validation
31
(52)
Chester J. Trubinski
Sterilization Validation
83
(76)
Michael J. Akers
Neil R. Anderson
Validation of Solid Dosage Forms
159
(32)
Jeffrey S. Rudolph
Robert J. Sepelyak
Validation for Medical Devices
191
(22)
Toshiaki Nishihata
Validation of Biotechnology Processes
213
(24)
Gail Sofer
Transdermal Process Validation
237
(52)
Charlie Neal, Jr.
Validation of Lyophilization
289
(40)
Edward H. Trappler
Validation of Inhalation Aerosols
329
(34)
Christopher J. Sciarra
John J. Sciarra
Process Validation of Pharmaceutical Ingredients
363
(38)
Robert A. Nash
Qualification of Water and Air Handling Systems
401
(42)
Kunio Kawamura
Equipment and Facility Qualification
443
(22)
Thomas L. Peither
Validation and Verification of Cleaning Processes
465
(42)
William E. Hall
Validation of Analytical Methods and Processes
507
(18)
Ludwig Huber
Computer System Validation: Controlling the Manufacturing Process
525
(78)
Tony de Claire
Integrated Packaging Validation
603
(44)
Mervyn J. Frederick
Analysis of Retrospective Production Data Using Quality Control Charts
647
(20)
Peter H. Cheng
John E. Dutt
Statistical Methods for Uniformity and Dissolution Testing
667
(32)
James S. Bergum
Merlin L. Utter
Change Control and SUPAC
699
(50)
Nellie Helen Waterland
Christopher C. Kowtna
Process Validation and Quality Assurance
749
(44)
Carl B. Rifno
Validation in Contract Manufacturing
793
(12)
Dilip M. Parikh
Terminology of Nonaseptic Process Validation
805
(18)
Kenneth G. Chapman
Harmonization, GMPs, and Validation
823
(34)
Alfred H. Wachter
Index
857
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