Handbook of Validation in Pharmaceutical Processes, Fourth Edition

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Description

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



Auteur

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 USP's Microbiology and Sterility Assurance Expert Committee for 2005-2015. He is a frequent author and lecturer on sterilization, aseptic processing and process validation.



Contenu

Chapter 1 Why Validation?

James Agalloco

Chapter 2 Facility Design for Validation

Phil DeSantis

Chapter 3 Modular Facilities - Meeting the Need for Flexibility

Maik Jornitz and Sidney Backstrom

Chapter 4 Commissioning and Qualification

Phil DeSantis and S. Ostrove

Chapter 5 Design & Quaification of Controlled Environments

Franco De Vecchi and Phil DeSantis

Chapter 6 Validation of Pharmaceutical Water Systems

William V. Collentro

Chapter 7 Validation of Critical Utilities

David W. Maynard

Chapter 8 Calibration and Metrology

Goran Bringert

Chapter 9 Risk Management and Thermal Validation

Goran Bringert

Chapter 10 Change Control

S. Osgrove and Phil DeSantis

Chapter 11 MICROBIOLOGY OF STERILIZATION PROCESSES

John Shirtz

Chapter 12 Biological Indicators

Hurt McCauley and Nicole Robichaud

Chapter 13 Steam Sterilization in Autoclaves

Phil DeSantis

Chapter 14 Validation of Terminal Sterilization

Kevin D. Trupp and Thomas J. Berger

Chapter 15 Steam Sterilization-in-Place Technology and Validation

James Agalloco

Chapter 16 Dry Heat Sterilization

George Schaeffer and Kishore Warrier

Chapter 17 Depyrogenation by Inactivation and Removal

Karen Zink McCullough and Allen Burgenson

Chapter 18 Ethylene Oxide Sterilization

James Agalloco

Chapter 19 Validation of chlorine dioxide Sterilization

Mark A. Czarneski and Paul Lorcheim

Chapter 20 Liquid Phase Sterilization

James Agalloco

Chapter 21 Vapor Sterilization and Decontamination

James Agalloco

Chapter 22 Validation of the Radiation Sterilization of Pharmaceuticals

Geoffrey P. Jacobs

Chapter 23 Validation of Sterilizing Grade Filters

Suraj B. Baloda

Chapter 24 Disinfecting Agents: The Art of Disinfection

Arthur Vellutato Jr

Chapter 25 Cleaning and Disinfecting Laminar Flow Workstations, Bio Safety Cabinets and Fume Hoods

Arthur Vellutato Jr

Chapter 26 Contamination Control for Component Introduction to Classified Areas

Arthur Vellutato Jr

Chapter 27 Aseptic Processing for Dosage Form Manufacture

James Agalloco & James Akers

Chapter 28 Validation of Manual Aseptic Processes

James Agalloco & James Akers

Chapter 29 Validation of Aseptic Processing for Bulk Pharmaceutical Chemicals

James Agalloco and Phil DeSantis

Chapter 30 Qualification and Validation of Advanced Aseptic Processing Technologies

James Agalloco & James Akers

Chapter 31 Total Particle Monitoring

Mark Hallworth

Chapter 32 Environmental Monitoring

Jeanne Moldenhauer

Chapter 33 Validation of Container Component Preparation

William G. Lindboe

Chapter 34 Validation of Lyophilization

Joseph P. Brower

Chapter 35 Validation of Packaging Processes for Sterile Products

Charles Levine

Chapter 36 Validation of Active Pharmaceutical Ingredients

James Agalloco & Phil DeSantis

Chapter 37 Cell Culture Process Validation including Cell Bank Qualification

Anne B. Tolstrup, Steven I. Max, Denis Drapeau and Timothy S. Charlebois

Chapter 38 Validation of Recovery and Purification Processes

Frank Riske and Howard L. Levine

Chapter 39 Validation of Process Chromatography

Günter Jagschies

Chapter 40 Single Use Technologies and Systems

A. Mark Trotter and Derek Pendlebury

Chapter 41 Considerations for Process Validation for Cell and Gene Therapies

Karen Zink McCullough, Anthony Thatcher and Merrick Endejann

Chapter 42 Validation of Solid Dosage Forms

William G. Lindboe

Chapter 43 Validation of Validation of Oral / Topical Liquids & Semi-Solids

William G. Lindboe

Chapter 44 Validation of Non-Sterile Packaging Operations

William G. Lindboe

Chapter 45 Validation of Cleaning Processes

Rebecca Brewer

Chapter 46 Validation of Training

Chris Smalley

Chapter 47 Vendor Qualification and Validation

Maik Jornitz

Chapter 48 Validation of Clinical Trial Manufacturing

Warren Charlton and Tom Ingallinera

Chapter 49 Validation of New Products

Norman Elder

Chapter 50 Retrospective / Continuous Process Validation

Kevin M Jenkins

Chapter 51 Validation & 6 Sigma

Robert Bottome

Chapter 52 Validation and Contract Manufacturing

Michael C. Beckloff

Chapter 53 Computerized Systems Validation

Saeed Tafreshi

Chapter 54 Risk Based Validation of Laboratory Information Management Systems

RD McDowall and Jeff Eshelman

Chapter 55 Control Systems Validation

Phil DeSantis and Steven Osgrove

Chapter 56 Process Analytical Technology and Validation

Ajaz Hussein

Chapter 57 Validation of Analytical Procedures and Physical Methods

Francis E. Beideman

Chapter 58 Validation of Microbial Methods

Anthony Grilli

Chapter 59 "Rapid Methods for Aseptic Processing and Their Validation"

Jeanne Moldenhauer

Chapter 60 Extractables and Leachables in Drug Products: An Overview

Will Parker and Don DeCou

Chapter 61 Evolution and Implementation of Validation in the United States

James Agalloco and Phil DeSantis

Chapter 62 Validation in Europe - What are the Differences?

Trevor Deeks

Chapter 63 Japanese Approach to Validation

Satoshi Sugimoto, Mitsuo Mori, Kiyoshi Mochizuki, Keisuke Nishikawa, Takuji Ikeda, Yusuke Matsuda, Hiroaki Nakamura

Chapter 64 Organization of Validation in a MultiNational Pharmaceutical Company

Kevin M Jenkins

Chapter 65 Validation in a Small Pharmaceutical Company

Stephen C. Tarallo

Chapter 66 Regulatory Aspects of Process Validation in the United States

James Agalloco and Robert Mello

Chapter 67 The Future of Validation

James Agalloco and Phil DeSantis

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Détails sur le produit

Titre
Handbook of Validation in Pharmaceutical Processes, Fourth Edition
éditeur
EAN
9781000436013
Format
eBook (pdf)
Producteur
Taylor & Francis Ltd.
Genre
Médecine
Parution
28.10.2021
Protection contre la copie numérique
libre
Nombre de pages
1061
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