Equipment 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), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems. Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols. Incorporates good manufacturing processes into a compliant qualification program Provides examples of protocol layout Includes matrices for major process equipment, installation quality, operational quality, and performance quality requirements

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  • Author : Steven Ostrove
  • Publisher : Academic Press
  • Pages : 234 pages
  • ISBN : 0128175699
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKEquipment Qualification in the Pharmaceutical Industry

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),

Pharmaceutical Equipment Validation

Pharmaceutical Equipment Validation
  • Author : Phil Cloud
  • Publisher : CRC Press
  • Release : 31 August 1998
GET THIS BOOKPharmaceutical Equipment Validation

While FDA regulations, cGMP, GLP, GCP, and the industry standard ISO 9000 require that documentation be established and followed, they do not provide guidelines on how to produce that documentation. Pharmaceutical Equipment Validation gives details on how to demonstrate compliance, what data to use, and how to produce the appropriate documentation. This book's user-friendly diagrams and other clear graphics illustrate key ideas throughout each protocol, offering a bird's-eye view of what is coming next-and they quickly guide you through the equipment

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

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

Pharmaceutical Microbiological Quality Assurance and Control

Pharmaceutical Microbiological Quality Assurance and Control
  • Author : David Roesti,Marcel Goverde
  • Publisher : John Wiley & Sons
  • Release : 02 January 2020
GET THIS BOOKPharmaceutical Microbiological Quality Assurance and Control

Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a

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

Commissioning, Qualification and Validation

Commissioning, Qualification and Validation
  • Author : Priscilla Browne
  • Publisher : Createspace Independent Publishing Platform
  • Release : 01 June 2017
GET THIS BOOKCommissioning, Qualification and Validation

Commissioning, Qualification and Validation (CQV) are requirements of modern facilities within the Life Science industry. Be it a Medical Device Manufacturing, pharmaceuticals or bio-pharmaceuticals, each present challenges in how new facilities, equipment, utilities and processes are introduced. Providing a defined approach to CQV aligns activities to ensure success and the timely completion. This book covers the core elements of CQV including the key steps, terminology and how an integrated approach to CQV can be achieved. Chapter 1-Introduction to Commissioning & Qualification (

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing
  • Author : Hamid Mollah,Mike Long,Harold Baseman
  • Publisher : John Wiley & Sons
  • Release : 18 March 2013
GET THIS BOOKRisk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

This book contains both the theory and practice of risk management (RM) and provides the background, tools, and application of risk in pharmaceutical and biologics manufacturing and operations. It includes case studies and specific examples of use of RM for biological and pharmaceutical product manufacture. The book also includes useful references and a bibliography for the reader who wishes to gain additional knowledge in the subject. It aids in assisting both industry and regulatory agencies to implement compliant and effective

Equipment Qualification of Ion Mobility Spectrometry and Method Development and Validation for Pharmaceutical Equipment Cleaning Validation

Equipment Qualification of Ion Mobility Spectrometry and Method Development and Validation for Pharmaceutical Equipment Cleaning Validation
  • Author : Amy Lee Heiser
  • Publisher : Unknown Publisher
  • Release : 29 May 2022
GET THIS BOOKEquipment Qualification of Ion Mobility Spectrometry and Method Development and Validation for Pharmaceutical Equipment Cleaning Validation

Ion mobility spectrometry (IMS) instrumentation has been identified as a suitable technology for the detection and reporting of drug product and detergent residues from pharmaceutical manufacturing equipment. Ion mobility is not a new technology, but is entering the field of cleaning validation because of tightened requirements from the US Food and Drug Administration (FDA). The purpose of this thesis is to outline a practical implementation of the analytical technique, Ion Mobility Spectrometry in a cleaning validation program. Ion Mobility Spectrometry (

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

Good Design Practices for GMP Pharmaceutical Facilities

Good Design Practices for GMP Pharmaceutical Facilities
  • Author : Terry Jacobs,Andrew A. Signore
  • Publisher : CRC Press
  • Release : 19 August 2016
GET THIS BOOKGood Design Practices for GMP Pharmaceutical Facilities

This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.

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 : 23 April 2004
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