Equipment Qualification in the Pharmaceutical Industry

Equipment Qualification in the Pharmaceutical Industry
Author: Steven Ostrove
Publsiher: Academic Press
Total Pages: 234
Release: 2019-06-13
ISBN 10: 0128175699
ISBN 13: 9780128175699
Language: EN, FR, DE, ES & NL

Equipment Qualification in the Pharmaceutical Industry Book Review:

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

Pharmaceutical Equipment Validation
Author: Phil Cloud
Publsiher: CRC Press
Total Pages: 456
Release: 1998-08-31
ISBN 10: 9781574910797
ISBN 13: 1574910795
Language: EN, FR, DE, ES & NL

Pharmaceutical Equipment Validation Book Review:

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

Handbook of Validation in Pharmaceutical Processes  Fourth Edition
Author: James Agalloco,Phil DeSantis,Anthony Grilli,Anthony Pavell
Publsiher: CRC Press
Total Pages: 1061
Release: 2021-10-28
ISBN 10: 1000436012
ISBN 13: 9781000436013
Language: EN, FR, DE, ES & NL

Handbook of Validation in Pharmaceutical Processes Fourth Edition Book Review:

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

How to Validate a Pharmaceutical Process
Author: Steven Ostrove
Publsiher: Academic Press
Total Pages: 218
Release: 2016-06-07
ISBN 10: 0128096535
ISBN 13: 9780128096536
Language: EN, FR, DE, ES & NL

How to Validate a Pharmaceutical Process Book Review:

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

Guideline on General Principles of Process Validation

Guideline on General Principles of Process Validation
Author: Anonim
Publsiher: Unknown
Total Pages: 25
Release: 1987
ISBN 10: 1928374650XXX
ISBN 13: UOM:39015029699587
Language: EN, FR, DE, ES & NL

Guideline on General Principles of Process Validation Book Review:

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing
Author: Hamid Mollah,Harold Baseman,Mike Long
Publsiher: John Wiley & Sons
Total Pages: 432
Release: 2013-03-18
ISBN 10: 0470552344
ISBN 13: 9780470552346
Language: EN, FR, DE, ES & NL

Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing Book Review:

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

Pharmaceutical Process Validation
Author: Bernard T. Loftus,Robert A. Nash
Publsiher: Marcel Dekker Incorporated
Total Pages: 286
Release: 1984
ISBN 10: 1928374650XXX
ISBN 13: UOM:39015006032687
Language: EN, FR, DE, ES & NL

Pharmaceutical Process Validation Book Review:

Validation of Pharmaceutical Processes

Validation of Pharmaceutical Processes
Author: James P. Agalloco,Frederick J. Carleton
Publsiher: CRC Press
Total Pages: 760
Release: 2007-09-25
ISBN 10: 1420019791
ISBN 13: 9781420019797
Language: EN, FR, DE, ES & NL

Validation of Pharmaceutical Processes Book Review:

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 Microbiological Quality Assurance and Control

Pharmaceutical Microbiological Quality Assurance and Control
Author: David Roesti,Marcel Goverde
Publsiher: John Wiley & Sons
Total Pages: 594
Release: 2020-01-02
ISBN 10: 1119356075
ISBN 13: 9781119356073
Language: EN, FR, DE, ES & NL

Pharmaceutical Microbiological Quality Assurance and Control Book Review:

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

Facility Validation

Facility Validation
Author: Graham C. Wrigley
Publsiher: CRC Press
Total Pages: 160
Release: 2004-03-29
ISBN 10: 1420025791
ISBN 13: 9781420025798
Language: EN, FR, DE, ES & NL

Facility Validation Book Review:

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.

Validation Standard Operating Procedures

Validation Standard Operating Procedures
Author: Syed Imtiaz Haider
Publsiher: CRC Press
Total Pages: 1144
Release: 2006-05-30
ISBN 10: 1420009419
ISBN 13: 9781420009415
Language: EN, FR, DE, ES & NL

Validation Standard Operating Procedures Book Review:

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

Good Design Practices for GMP Pharmaceutical Facilities

Good Design Practices for GMP Pharmaceutical Facilities
Author: Terry Jacobs,Andrew A. Signore
Publsiher: CRC Press
Total Pages: 536
Release: 2016-08-19
ISBN 10: 1482258919
ISBN 13: 9781482258912
Language: EN, FR, DE, ES & NL

Good Design Practices for GMP Pharmaceutical Facilities Book Review:

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

Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation
Author: Orlando Lopez
Publsiher: Taylor & Francis
Total Pages: 326
Release: 2018-10-02
ISBN 10: 1351704346
ISBN 13: 9781351704342
Language: EN, FR, DE, ES & NL

Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation Book Review:

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.

Pharmaceutical Blending and Mixing

Pharmaceutical Blending and Mixing
Author: P. J. Cullen,Chris D. Rielly
Publsiher: John Wiley & Sons
Total Pages: 508
Release: 2015-07-20
ISBN 10: 0470710551
ISBN 13: 9780470710555
Language: EN, FR, DE, ES & NL

Pharmaceutical Blending and Mixing Book Review:

Written in four parts, this book provides a dedicated and in-depth reference for blending within the pharmaceutical manufacturing industry. It links the science of blending with regulatory requirements associated with pharmaceutical manufacture. The contributors are a combination of leading academic and industrial experts, who provide an informed and industrially relevant perspective of the topic. This is an essential book for the pharmaceutical manufacturing industry, and related academic researchers in pharmaceutical science and chemical and mechanical engineering.

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
Publsiher: Unknown
Total Pages: 51
Release: 2012
ISBN 10: 1928374650XXX
ISBN 13: OCLC:845046920
Language: EN, FR, DE, ES & NL

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

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 (IMS) is fast and specific for the analysis of small organic molecules and has been gaining popularity in the pharmaceutical industry. The challenge in the implementation of any new analytical technique in a pharmaceutical laboratory is establishing suitable methodology and this thesis will outline the steps taken for developing and validating a method for detection of the antihistamine drug Loratadine. The author will also provide a detailed introduction to the requirements of equipment qualification, cleaning validation and analytical method validation programs in the pharmaceutical industry.

Sterile Manufacturing

Sterile Manufacturing
Author: Sam A. Hout
Publsiher: CRC Press
Total Pages: 206
Release: 2021-07-05
ISBN 10: 1000406091
ISBN 13: 9781000406092
Language: EN, FR, DE, ES & NL

Sterile Manufacturing Book Review:

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.

Pharmaceutical Quality Assurance

Pharmaceutical Quality Assurance
Author: Mr. Manohar A. Potdar
Publsiher: Pragati Books Pvt. Ltd.
Total Pages: 424
Release: 2006
ISBN 10: 9788185790596
ISBN 13: 8185790590
Language: EN, FR, DE, ES & NL

Pharmaceutical Quality Assurance Book Review:

Commissioning Qualification and Validation

Commissioning  Qualification and Validation
Author: Priscilla Browne
Publsiher: Createspace Independent Publishing Platform
Total Pages: 200
Release: 2017-06
ISBN 10: 9781547091256
ISBN 13: 1547091258
Language: EN, FR, DE, ES & NL

Commissioning Qualification and Validation Book Review:

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 (C&Q) Chapter 2-Facilities Chapter 3-Introduction to Validation Chapter 4-Design Requirement Chapter 5-Risk Management Chapter 6-Validation Planning Chapter 7-Clean Utilities Chapter 8-Equipment Validation Chapter 9-Process Validation Chapter 10-Test Method Validation Chapter 11-Supplier Validation Chapter 12-Summary of Good Manufacturing Practices (GMP)

GAMP 5

GAMP 5
Author: Anonim
Publsiher: Ispe Headquarters
Total Pages: 352
Release: 2008
ISBN 10: 9781931879613
ISBN 13: 1931879613
Language: EN, FR, DE, ES & NL

GAMP 5 Book Review:

Pharmaceutical Equipment Validation

Pharmaceutical Equipment Validation
Author: Phillip A. Cloud
Publsiher: Unknown
Total Pages: 443
Release: 1998
ISBN 10: 9780367802998
ISBN 13: 0367802996
Language: EN, FR, DE, ES & NL

Pharmaceutical Equipment Validation Book Review:

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.