Equipment Qualification in the Pharmaceutical Industry Book

Equipment Qualification in the Pharmaceutical Industry


  • Author : Steven Ostrove
  • Publisher : Academic Press
  • Release Date : 2019-06-13
  • Genre: Business & Economics
  • Pages : 234
  • ISBN 10 : 9780128175699

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Equipment Qualification in the Pharmaceutical Industry Excerpt :

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

Pharmaceutical Equipment Validation Book

Pharmaceutical Equipment Validation


  • Author : Phil Cloud
  • Publisher : CRC Press
  • Release Date : 1998-08-31
  • Genre: Medical
  • Pages : 456
  • ISBN 10 : 1574910795

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Pharmaceutical Equipment Validation Excerpt :

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 validation. The author provides a thorough understanding of how to prepare, test, and complete equipment qualification protocols. He also explains how to perform qualification testing and whether to test the equipment for a worst case scenario. No other book deals exclusively with the key issues of equipment qualification and process validation for pharmaceutical process equipment-and provides instructions on how to achieve it. With pragmatic approach, this book includes 38 useful protocol templates, already completed, that provide instant answers to most protocol writing and testing questions. These templates cover specific equipment types, such, and provide accurate, industry acceptable equipment qualification protocols. Step-by-step, they show how to qualify each piece of equipment, and they provide a check for readers own protocols.

Handbook of Validation in Pharmaceutical Processes  Fourth Edition Book

Handbook of Validation in Pharmaceutical Processes Fourth Edition


  • Author : James Agalloco
  • Publisher : CRC Press
  • Release Date : 2021-10-28
  • Genre: Medical
  • Pages : 1061
  • ISBN 10 : 9781000436013

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Handbook of Validation in Pharmaceutical Processes Fourth Edition Excerpt :

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

How to Validate a Pharmaceutical Process Book

How to Validate a Pharmaceutical Process


  • Author : Steven Ostrove
  • Publisher : Academic Press
  • Release Date : 2016-06-07
  • Genre: Medical
  • Pages : 218
  • ISBN 10 : 9780128096536

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How to Validate a Pharmaceutical Process Excerpt :

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

Cleaning Validation Manual Book

Cleaning Validation Manual


  • Author : Syed Imtiaz Haider
  • Publisher : CRC Press
  • Release Date : 2010-05-24
  • Genre: Medical
  • Pages : 608
  • ISBN 10 : 9781439826614

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Cleaning Validation Manual Excerpt :

During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them provides a single database with convenient, ready-to-

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing Book
Score: 4
From 1 Ratings

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing


  • Author : Hamid Mollah
  • Publisher : John Wiley & Sons
  • Release Date : 2013-03-18
  • Genre: Science
  • Pages : 432
  • ISBN 10 : 9780470552346

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Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing Excerpt :

Sets forth tested and proven risk management practices in drug manufacturing Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for: Basic foundation of risk management principles, practices, and applications Tested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes Recent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturing Case studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturing Bibliography and extensive references leading to the literature and helpful resources in the field With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing.

Pharmaceutical Process Validation Book

Pharmaceutical Process Validation


  • Author : Bernard T. Loftus
  • Publisher : Marcel Dekker Incorporated
  • Release Date : 1984
  • Genre: Medical
  • Pages : 286
  • ISBN 10 : UOM:39015006032687

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Pharmaceutical Process Validation Excerpt :

Pharmaceutical Microbiological Quality Assurance and Control Book
Score: 5
From 1 Ratings

Pharmaceutical Microbiological Quality Assurance and Control


  • Author : David Roesti
  • Publisher : John Wiley & Sons
  • Release Date : 2020-01-02
  • Genre: Technology & Engineering
  • Pages : 594
  • ISBN 10 : 9781119356073

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Pharmaceutical Microbiological Quality Assurance and Control Excerpt :

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 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

Good Quality Practice  GQP  in Pharmaceutical Manufacturing  A Handbook Book

Good Quality Practice GQP in Pharmaceutical Manufacturing A Handbook


  • Author : Jordi Botet
  • Publisher : Bentham Science Publishers
  • Release Date : 2015-09-28
  • Genre: Medical
  • Pages : 504
  • ISBN 10 : 9781681081144

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Good Quality Practice GQP in Pharmaceutical Manufacturing A Handbook Excerpt :

Pharmaceutical manufacturing can be viewed as a supply chain which spans from the production and purchase of the starting and packaging materials through the manufacture of dosage forms until the safe reception of the finished product by the patient. The entire chain comprises of several processes: auditing, materials purchase (procurement), production, storage, distribution, quality control, and quality assurance. The quality standard for pharmaceutical production is ‘current good manufacturing practice (CGMP)’‘, which is applied within the frame of a pharmaceutical quality system (PQS). This implementation, however, requires a scientific approach and has to take into account several elements such as risk assessment, life cycle, patient protection, among other factors. Hence, pharmaceutical manufacturing is a complex subject in terms of regulation, given the technical and managerial requirements. This comprehensive handbook describes CGMP for new professionals who want to understand and apply the elements which build up pharmaceutical quality assurance. The book gives details about basic quality control requirements (such as risk management, quality hazards and management systems, documentation, clean environments, personnel training) and gives guidelines on regulatory aspects. This is an ideal handbook for undergraduates studying pharmaceutical or industrial manufacturing and supply chains as well for entrepreneurs and quality control professionals seeking to learn about CGMP standards and implementing quality assurance systems in the pharmaceutical sector.

Facility Validation Book

Facility Validation


  • Author : Graham C. Wrigley
  • Publisher : CRC Press
  • Release Date : 2004-03-29
  • Genre: Medical
  • Pages : 160
  • ISBN 10 : 9781420025798

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Facility Validation Excerpt :

Often considered a necessary evil by the pharmaceutical industry, validation is still understood by many as unrestrained bureaucracy, paperwork, and procedures whose roots and logic are obscure and only serve to slow down progress. Thoroughly defining the philosophy, application, and processes, Facility Validation: Theory, Practice, and Tools explores the validation issues relevant to the start-up of a new or upgraded manufacturing facility. The author describes policies, guidelines, and regulations relating to GMPs in the pharmaceutical industry and explores the relationship between these GMPs and the validation process. He outlines the theory and clarifies the philosophy and key principles of validation such as life-cycle approach and qualification practices. The book includes coverage of common pitfalls and how to avoid them, the difficulties and constraints a validation team has to manage, and the dangers of not adopting and following the recommended best practices. Facility validation has, in fact, become good business. It can be a tool for enhancing reliability, cost, and quality. This book makes the case that design, engineering, commissioning, and validation activities can be integrated and streamlined to accelerate a pharmaceutical manufacturing plant start-up effort, and demonstrates how to use best practices to achieve the results you desire in your organization.

Sterile Manufacturing Book

Sterile Manufacturing


  • Author : Sam A. Hout
  • Publisher : CRC Press
  • Release Date : 2021-07-05
  • Genre: Technology & Engineering
  • Pages : 206
  • ISBN 10 : 9781000406092

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Sterile Manufacturing Excerpt :

This book highlights key ideas and factors to coach and guide professionals involved in learning about Sterile Manufacturing and operational requirements. It covers regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH, emphasizing good manufacturing practice and inspection requirements in the manufacturing of medicinal products. Additionally, this book provides the fundamentals of aseptic techniques, quality by design, risk assessment, and management in support of sterile operations applications. It creates a link to the implementation of business practices in drug manufacturing and healthcare and forms a correlation between design strategies including a step-by-step process to ensure reliability, safety, and efficacy of healthcare products for human and animal use. The book also provides a connection between drug production and regulated applications by offering a review of the basic elements of sterile processing, and how to remain viable with solid strategic planning. The book is a concise reference for professionals and learners in the field of sterile operations that governs primarily, pharmaceutical and medical device space, but can also extend to food and cosmetics that require clean (aseptic) manufacturing applications. It also helps compounding pharmacists and GMP inspectors and auditors.

Good Design Practices for GMP Pharmaceutical Facilities Book

Good Design Practices for GMP Pharmaceutical Facilities


  • Author : Terry Jacobs
  • Publisher : CRC Press
  • Release Date : 2016-08-19
  • Genre: Medical
  • Pages : 536
  • ISBN 10 : 9781482258912

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Good Design Practices for GMP Pharmaceutical Facilities Excerpt :

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.

Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation Book

Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation


  • Author : Orlando Lopez
  • Publisher : Taylor & Francis
  • Release Date : 2018-10-02
  • Genre: Business & Economics
  • Pages : 326
  • ISBN 10 : 9781351704342

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Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation Excerpt :

Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority’s requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions. This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved.

Validation of Pharmaceutical Processes Book
Score: 4
From 5 Ratings

Validation of Pharmaceutical Processes


  • Author : James P. Agalloco
  • Publisher : CRC Press
  • Release Date : 2007-09-25
  • Genre: Medical
  • Pages : 760
  • ISBN 10 : 9781420019797

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Validation of Pharmaceutical Processes Excerpt :

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