How to Validate a Pharmaceutical Process

Book How to Validate a Pharmaceutical Process Cover

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  • Publisher : Academic Press
  • Release : 07 June 2016
  • ISBN : 9780128096536
  • Page : 218 pages
  • Rating : 4.5/5 from 103 voters

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How to Validate a Pharmaceutical Process provides a “how to approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and reasoning behind processes and protocols. It also addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. Understanding the “why is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners engaged in pharmaceutical process validation. Thoroughly referenced and based on the latest research and literature Illustrates the most common issues related to developing and implementing a sustainable process validation program and provides examples on how to be successful Covers important topics such as the lifecycle approach, quality by design, risk assessment, critical process parameters, US and international regulatory guidelines, and more

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How to Validate a Pharmaceutical Process

How to Validate a Pharmaceutical Process
  • Author : Steven Ostrove
  • Publisher : Academic Press
  • Release Date : 2016-06-07
  • ISBN : 9780128096536
GET THIS BOOKHow to Validate a Pharmaceutical Process

How to Validate a Pharmaceutical Process provides a “how to approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and reasoning behind processes and protocols. It also addresses practical problems and offers solutions to qualify and validate a pharmaceutical process. Understanding the “why is critical to a successful and defensible process validation, making this book an essential research companion for all practitioners

Handbook of Validation in Pharmaceutical Processes, Fourth Edition

Handbook of Validation in Pharmaceutical Processes, Fourth Edition
  • Author : James Agalloco,Phil DeSantis,Anthony Grilli,Anthony Pavell
  • Publisher : CRC Press
  • Release Date : 2021-10-28
  • ISBN : 9781000436013
GET THIS BOOKHandbook of Validation in Pharmaceutical Processes, Fourth Edition

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

Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes
  • Author : James P. Agalloco,Frederick J. Carleton
  • Publisher : CRC Press
  • Release Date : 2007-09-25
  • ISBN : 9781420019797
GET THIS BOOKValidation of Pharmaceutical Processes

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

Pharmaceutical Process Validation

Pharmaceutical Process Validation
  • Author : Bernard T. Loftus,Robert A. Nash
  • Publisher : Marcel Dekker Incorporated
  • Release Date : 1984
  • ISBN : UOM:39015006032687
GET THIS BOOKPharmaceutical Process Validation

Process Validation in Manufacturing of Biopharmaceuticals, Third Edition

Process Validation in Manufacturing of Biopharmaceuticals, Third Edition
  • Author : Anurag S. Rathore,Gail Sofer
  • Publisher : CRC Press
  • Release Date : 2012-05-09
  • ISBN : 9781439850930
GET THIS BOOKProcess Validation in Manufacturing of Biopharmaceuticals, Third Edition

Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of

Pharmaceutical Process Validation

Pharmaceutical Process Validation
  • Author : Robert A. Nash,Alfred H. Wachter
  • Publisher : CRC Press
  • Release Date : 2003-03-27
  • ISBN : 0824708385
GET THIS BOOKPharmaceutical Process Validation

The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.

Method Validation in Pharmaceutical Analysis

Method Validation in Pharmaceutical Analysis
  • Author : Joachim Ermer,John H. McB. Miller
  • Publisher : John Wiley & Sons
  • Release Date : 2006-03-06
  • ISBN : 9783527604470
GET THIS BOOKMethod Validation in Pharmaceutical Analysis

Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on

Validation Standard Operating Procedures

Validation Standard Operating Procedures
  • Author : Syed Imtiaz Haider
  • Publisher : CRC Press
  • Release Date : 2006-05-30
  • ISBN : 9781420009415
GET THIS BOOKValidation Standard Operating Procedures

Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluati

Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation
  • Author : Igor Gorsky,Harold S. Baseman
  • Publisher : Academic Press
  • Release Date : 2019-11-27
  • ISBN : 9780128094464
GET THIS BOOKPrinciples of Parenteral Solution Validation

Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges

Statistical Design and Analysis in Pharmaceutical Science

Statistical Design and Analysis in Pharmaceutical Science
  • Author : Shein-Chung Chow,Jen-pei Liu
  • Publisher : CRC Press
  • Release Date : 2018-10-03
  • ISBN : 9781482273137
GET THIS BOOKStatistical Design and Analysis in Pharmaceutical Science

"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."

Development and Validation of Analytical Methods

Development and Validation of Analytical Methods
  • Author : Christopher M. Riley,Thomas W. Rosanske
  • Publisher : Elsevier
  • Release Date : 1996-05-29
  • ISBN : 0080530354
GET THIS BOOKDevelopment and Validation of Analytical Methods

The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the

Design and Analysis of Clinical Trials

Design and Analysis of Clinical Trials
  • Author : Shein-Chung Chow,Jen-Pei Liu
  • Publisher : Wiley-Interscience
  • Release Date : 1998-06-23
  • ISBN : UOM:39015047055416
GET THIS BOOKDesign and Analysis of Clinical Trials

A unique, unifying treatment for statistics and science in clinical trials What sets this volume apart from the many books dealing with clinical trials is its integration of statistical and clinical disciplines. Stressing communication between biostatisticians and clinical scientists, this work clearly relates statistical interpretation to clinical issues arising in different stages of pharmaceutical research and development. Plus, the principles presented here are universal enough to be easily adapted in non-biopharmaceutical settings. Design and Analysis of Clinical Trials tackles concepts

Pharmaceutical Computer Systems Validation

Pharmaceutical Computer Systems Validation
  • Author : Guy Wingate
  • Publisher : CRC Press
  • Release Date : 2016-04-19
  • ISBN : 9781420088953
GET THIS BOOKPharmaceutical Computer Systems Validation

Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews r

Analytical Method Validation and Instrument Performance Verification

Analytical Method Validation and Instrument Performance Verification
  • Author : Chung Chow Chan,Y. C. Lee,Herman Lam,Xue-Ming Zhang
  • Publisher : John Wiley & Sons
  • Release Date : 2004-04-23
  • ISBN : 9780471463719
GET THIS BOOKAnalytical Method Validation and Instrument Performance Verification

Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools

Validating Pharmaceutical Systems

Validating Pharmaceutical Systems
  • Author : John Andrews
  • Publisher : CRC Press
  • Release Date : 2005-08-03
  • ISBN : 084932324X
GET THIS BOOKValidating Pharmaceutical Systems

All too often, the words "computer validation" strike terror into the hearts of those new to the process and may even cause those familiar with it to tremble. Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing delineates GCP, GLP, and GMP regulatory requirements and provides guidance from seasoned practitioners on how to fulfill them. John Andrews and his team tackle the perceived complexities surrounding the validation of a wide variety of automated systems. Sprinkled with case studies and