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Handbook of Validation in Pharmaceutical Processes, Fourth Edition 4th edition [Hardback]

Edited by (Fresenius Kabi USA), Edited by (Agalloco & Associates, Belle Mead, New Jersey, USA), Edited by (FOCUS Scientific Services, LLC, Morris Township, New Jersey, USA), Edited by
  • Formāts: Hardback, 1043 pages, height x width: 279x216 mm, weight: 5730 g, 198 Tables, black and white; 172 Line drawings, black and white; 58 Halftones, black and white; 230 Illustrations, black and white
  • Izdošanas datums: 29-Oct-2021
  • Izdevniecība: CRC Press
  • ISBN-10: 0367754290
  • ISBN-13: 9780367754297
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  • Cena: 301,80 €
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Handbook of Validation in Pharmaceutical Processes, Fourth Edition 4th editionPalielināt
  • Formāts: Hardback, 1043 pages, height x width: 279x216 mm, weight: 5730 g, 198 Tables, black and white; 172 Line drawings, black and white; 58 Halftones, black and white; 230 Illustrations, black and white
  • Izdošanas datums: 29-Oct-2021
  • Izdevniecība: CRC Press
  • ISBN-10: 0367754290
  • ISBN-13: 9780367754297
Citas grāmatas par šo tēmu:
Permanent link: https://www.kriso.lv/db/9780367754297.html
Keywords:
"Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health caremanufacturers and pharmaceutical industry professionals"--

Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals.

Key Features:

  • provides an in-depth discussion of recent advances in sterilization
  • identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions
  • explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results
  • New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture.


Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive.

About the Editors xi
Contributors xiii
Preface to the Fourth Edition xv
Fourth Edition History xvii
Chapter 1 Why Validation? 1(4)
James Agalloco
Chapter 2 Facility Design for Validation 5(28)
Phil DeSantis
Chapter 3 Modular Facilities-Meeting the Need for Flexibility 33(16)
Maik Jornitz
Sidney Backstrom
Chapter 4 Commissioning and Qualification 49(18)
Phil DeSantis
Steven Ostrove
Chapter 5 Design and Qualification of Controlled Environments 67(22)
Franco DeVecchi
Phil DeSantis
Chapter 6 Validation of Pharmaceutical Water Systems 89(50)
William V. Collentro
Chapter 7 Validation of Critical Utilities 139(8)
David Maynard
Chapter 8 Calibration and Metrology 147(12)
Goran Bringert
Chapter 9 Temperature Measurements 159(20)
Goran Bringert
Chapter 10 Change Control 179(8)
Phil DeSantis
Steven Ostrove
Chapter 11 Microbiology of Sterilization Processes 187(18)
John Shirtz
Chapter 12 Biological Indicators for Sterilization 205(12)
Kurt McCauley
Nicole Robichaud
Karlin Gardner
Crystal Hostler
Chapter 13 Steam Sterilization in Autoclaves 217(14)
Phil DeSantis
Chapter 14 Validation of Terminal Sterilization 231(14)
Kevin D. Trupp
Thomas J. Berger
Chapter 15 Steam Sterilization-in-Place 245(26)
James Agalloco
Chapter 16 Validation of Dry Heat Sterilization and Depyrogenation 271(30)
George Sheaffer
Kishore Warrier
Chapter 17 Depyrogenation by Inactivation and Removal 301(14)
Karen Zink McCullough
Allen Burgenson
Chapter 18 Ethylene Oxide Sterilization 315(10)
James Agalloco
Chapter 19 Validation of Chlorine Dioxide Sterilization 325(14)
Mark A. Czarneski
Paul Lorcheim
Chapter 20 Liquid Phase Sterilization 339(6)
James Agalloco
Chapter 21 Vapor Phase Sterilization and Decontamination 345(10)
James Agalloco
Chapter 22 Validation of the Radiation Sterilization of Pharmaceuticals 355(20)
Geoffrey P. Jacobs
Chapter 23 Validation of Sterilizing-Grade Filters 375(20)
Suraj B. Baloda
Chapter 24 Disinfecting Agents: The Art of Disinfection 395(24)
Arthur Vellutato Jr
Chapter 25 Cleaning and Disinfecting Laminar Flow Workstations, Bio Safety Cabinets, and Fume Hoods 419(10)
Arthur Vellutato Jr
Chapter 26 Contamination Control for Incoming Components to Classified Areas: "War at the Door®" 429(14)
Arthur Vellutato Jr
Chapter 27 Aseptic Processing of Sterile Dosage Forms 443(14)
James Agalloco
James Akers
Chapter 28 Manual Aseptic Processes 457(6)
James Agalloco
James Akers
Chapter 29 Aseptic Processing for Sterile Bulk Pharmaceutical Chemicals 463(8)
James Agalloco
Phil DeSantis
Chapter 30 Qualification and Validation of Advanced Aseptic Processing Technologies 471(10)
James Agalloco
James Akers
Chapter 31 Total Particle Counts 481(22)
Mark Hallworth
Chapter 32 Environmental Monitoring 503(14)
Jeanne Moldenhauer
Chapter 33 Validation of Container Preparation Processes 517(10)
William G. Lindboe Jr
Chapter 34 Validation of Lyophilization 527(22)
Joseph P. Brower
Chapter 35 Validation of Sterile Drug Product Packaging Processes 549(18)
Charles Levine
Chapter 36 Validation of Active Pharmaceutical Ingredients 567(12)
James Agalloco
Phil DeSantis
Chapter 37 Cell Culture Process Validation Including Cell Bank Qualification 579(14)
Anne B. Tolstrup
Steven I. Max
Denis Drapeau
Timothy S. Charlebois
Chapter 38 Validation of Recovery and Purification Processes 593(22)
Frank Riske
Howard L. Levine
Chapter 39 Validation of Process Chromatography 615(16)
Gunter Jagschies
Chapter 40 Single-Use Technologies and Systems 631(22)
A. Mark Trotter
Derek Pendlebury
Chapter 41 Considerations for Process Validation for Cell and Gene Therapies 653(16)
Karen Zink McCullough
Anthony Thatcher
Merrick Endejann
Chapter 42 Validation of Solid Dosage Finished Goods 669(18)
William G. Lindboe Jr
Chapter 43 Validation of Oral/Topical Liquids and Semi-Solids 687(14)
William G. Lindboe Jr
Chapter 44 Validation of Non-Sterile Packaging Operations 701(10)
William G. Lindboe Jr
Chapter 45 Cleaning Validation for the Pharmaceutical, Biopharmaceutical, Cosmetic, Nutraceutical, Medical Device and Diagnostic Industries 711(38)
Rebecca Brewer
Chapter 46 Validation of Training 749(14)
Chris Smalley
Chapter 47 Vendor Qualification and Validation 763(12)
Maik Jornitz
Chapter 48 Validation for Clinical Manufacturing 775(10)
Warren Charlton
Tom Ingallinera
Chapter 49 Validation of New Products 785(6)
Norman Elder
Chapter 50 Retrospective Validation 791(14)
Kevin M. Jenkins
Chapter 51 Validation and Six Sigma 805(8)
Robert Bottome
Chapter 52 Validation and Contract Manufacturing 813(14)
Michael C. Beckloff
Chapter 53 Computerized Systems Validation 827(24)
Saeed Tafreshi
Chapter 54 Risk Based Validation of a Laboratory Information Management System (LIMS) 851(22)
Roger D. McDowall
Jeff Eshelman
Chapter 55 Control Systems Validation 873(10)
Phil DeSantis
Steven Ostrove
Chapter 56 Process Analytical Technology (PAT): Understanding Validity of Pharmaceutical Quality Control and Assurance 883(34)
Ajaz S. Hussain
Chapter 57 Validation of Analytical Procedures and Physical Methods 917(4)
Francis E. Beideman
Chapter 58 Validation of Microbiological Methods 921(8)
Anthony Grilli
Chapter 59 Rapid Methods for Pharmaceutical Processing and Their Validation 929(14)
Jeanne Moldenhauer
Chapter 60 Extractables and Leachables in Drug Products: An Overview 943(10)
William Parker
Don DeCou
Chapter 61 Evolution and Implementation of Validation in the United States 953(12)
James Agalloco
Phil DeSantis
Chapter 62 Validation in Europe-What Are the Differences? 965(18)
Trevor Deeks
Chapter 63 Japanese Approach to Validation 983(14)
Satoshi Sugimoto
Mitsuo Mori
Kiyoshi Mochizuki
Keisuke Nishikawa
Takuji Ikeda
Yusuke Matsuda
Hiroaki Nakamura
Yasuhito Ikematsu
Chapter 64 Organization of Validation in a Multinational Pharmaceutical Company 997(10)
Kevin M. Jenkins
Chapter 65 Validation in a Small Pharmaceutical Company 1007(8)
Stephen C. Tarallo
Chapter 66 Regulatory Aspects of Process Validation in the United States 1015(6)
James Agalloco
Robert Mello
Chapter 67 The Future of Validation 1021(4)
James Agalloco
Phil DeSantis
Index 1025
James Agalloco is President of Agalloco & Associates, a technical service firm to the pharmaceutical and biotechnology industry. He was previously Director, Worldwide Validation and Automated Technology for Bristol-Myers Squibb. He received his BS in Chemical Engineering from Pratt Institute in 1968 and his MS, also in Chemical Engineering from Polytechnic Institute of New York in 1979. He received his MBA in Pharmaceutical Studies from Fairleigh Dickinson University in 1983. He is a past President of the Parenteral Drug Association and served as an Officer or Director from 1982 to 1993. He is a member of USPs Microbiology and Sterility Assurance Expert Committee for 2005-2015. He is a frequent author and lecturer on sterilization, aseptic processing and process validation.