How 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 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

Produk Detail:

  • Author : Steven Ostrove
  • Publisher : Academic Press
  • Pages : 218 pages
  • ISBN : 0128096535
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKHow to Validate a Pharmaceutical Process

How to Validate a Pharmaceutical Process

How to Validate a Pharmaceutical Process
  • Author : Steven Ostrove
  • Publisher : Academic Press
  • Release : 07 June 2016
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 : 28 October 2021
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

Method Validation in Pharmaceutical Analysis

Method Validation in Pharmaceutical Analysis
  • Author : Joachim Ermer,John H. McB. Miller
  • Publisher : John Wiley & Sons
  • Release : 06 March 2006
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 of Pharmaceutical Processes

Validation of Pharmaceutical Processes
  • Author : James P. Agalloco,Frederick J. Carleton
  • Publisher : CRC Press
  • Release : 25 September 2007
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

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 : 09 May 2012
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

Validation Standard Operating Procedures

Validation Standard Operating Procedures
  • Author : Syed Imtiaz Haider
  • Publisher : CRC Press
  • Release : 30 May 2006
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

Validating Pharmaceutical Systems

Validating Pharmaceutical Systems
  • Author : John Andrews
  • Publisher : CRC Press
  • Release : 03 August 2005
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

Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation
  • Author : Igor Gorsky,Harold S. Baseman
  • Publisher : Academic Press
  • Release : 27 November 2019
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

Equipment Qualification in the Pharmaceutical Industry

Equipment Qualification in the Pharmaceutical Industry
  • Author : Steven Ostrove
  • Publisher : Academic Press
  • Release : 13 June 2019
GET THIS BOOKEquipment Qualification in the Pharmaceutical Industry

Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ),

Validation: Essential Requirement in Pharmaceutical Industries

Validation: Essential Requirement in Pharmaceutical Industries
  • Author : Rakshit Thumar,Nishendu Nadpara,Umang Hirani
  • Publisher : LAP Lambert Academic Publishing
  • Release : 09 August 2022
GET THIS BOOKValidation: Essential Requirement in Pharmaceutical Industries

In the pharmaceutical, medical device, food, blood establishments, tissue establishments, and clinical trials industries, validation is the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment. It is a requirement for good manufacturing practices and other regulatory requirements. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including

Validation in Chemical Measurement

Validation in Chemical Measurement
  • Author : Paul De Bièvre,Helmut Günzler
  • Publisher : Springer Science & Business Media
  • Release : 12 January 2005
GET THIS BOOKValidation in Chemical Measurement

The validation of analytical methods is based on the characterisation of a measurement procedure (selectivity, sensitivity, repeatability, reproducibility). This volume collects 31 outstanding papers on the topic, mostly published in the period 2000-2003 in the journal "Accreditation and Quality Assurance". They provide the latest understanding, and possibly the rationale why it is important to integrate the concept of validation into the standard procedures of every analytical laboratory. In addition, this anthology considers the benefits to both: the analytical laboratory and the

Calibration and Validation of Analytical Methods

Calibration and Validation of Analytical Methods
  • Author : Mark Stauffer
  • Publisher : BoD – Books on Demand
  • Release : 25 April 2018
GET THIS BOOKCalibration and Validation of Analytical Methods

This book seeks to introduce the reader to current methodologies in analytical calibration and validation. This collection of contributed research articles and reviews addresses current developments in the calibration of analytical methods and techniques and their subsequent validation. Section 1, "Introduction," contains the Introductory Chapter, a broad overview of analytical calibration and validation, and a brief synopsis of the following chapters. Section 2 "Calibration Approaches" presents five chapters covering calibration schemes for some modern analytical methods and techniques. The last chapter in