Validation And Qualification In Analytical Laboratories Second Edition

Author : Ludwig Huber
Publisher : CRC Press
Page : 0 pages
File Size : 50,8 Mb
Release : 2007-07-23
Category : Medical
ISBN : 084938267X

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Validation and Qualification in Analytical Laboratories, Second Edition by Ludwig Huber Pdf

This Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards. With comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy incorporation in a laboratory. This title serves as a complete source to the subject, and explains how to develop and implement a validation strategy for routine, non-routine, and standard analytical methods, covering the entire equipment, hardware, and software qualification process. It also provides guidance on qualification of certified standards, in-house reference materials, and people qualification, as well as internal and third party laboratory audits and inspections.

Author : Ludwig Huber
Publisher : CRC Press
Page : 336 pages
File Size : 50,9 Mb
Release : 1998-10-31
Category : Medical
ISBN : 1574910809

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Validation and Qualification in Analytical Laboratories by Ludwig Huber Pdf

This book explains how to improve product quality while achieving compliance with the world's regulatory standards. A complete guide and reference, it teaches you how to develop and implement a validation strategy for routine, nonroutine, and standard analytical methods encompassing the entire equipment, hardware, and software qualification process. It includes examples and templates to help speed you through the validation process. Chromatographs, spectrophotometers, titrators, methods, reference compounds, and every possible item and category have been addressed. In addition to guidelines on the qualification of standards, certified and in-house reference materials, and employee qualification, it covers internal and third-party lab audits and inspections. Case studies, checklists, flowcharts, templates, and key SOPs support the text. All major regulations and quality standards are covered: US GLP, GMP, GCP, EN45001, ISO 9000 Series, NAMAS, ISO Guide 25, & corresponding interpretation & inspection guides.

Author : Chung Chow Chan,Herman Lam,Xue-Ming Zhang
Publisher : John Wiley & Sons
Page : 416 pages
File Size : 51,8 Mb
Release : 2011-03-01
Category : Science
ISBN : 9781118060315

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Practical Approaches to Method Validation and Essential Instrument Qualification by Chung Chow Chan,Herman Lam,Xue-Ming Zhang Pdf

Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirements Complementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testing. Readers will gain new and valuable insights that enable them to avoid common pitfalls in order to seamlessly conduct analytical method validation as well as instrument operation qualification and performance verification. Part 1, Method Validation, begins with an overview of the book's risk-based approach to phase appropriate validation and instrument qualification; it then focuses on the strategies and requirements for early phase drug development, including validation of specific techniques and functions such as process analytical technology, cleaning validation, and validation of laboratory information management systems Part 2, Instrument Performance Verification, explores the underlying principles and techniques for verifying instrument performance—coverage includes analytical instruments that are increasingly important to the pharmaceutical industry, such as NIR spectrometers and particle size analyzers—and offers readers a variety of alternative approaches for the successful verification of instrument performance based on the needs of their labs At the end of each chapter, the authors examine important practical problems and share their solutions. All the methods covered in this book follow Good Analytical Practices (GAP) to ensure that reliable data are generated in compliance with current Good Manufacturing Practices (cGMP). Analysts, scientists, engineers, technologists, and technical managers should turn to this book to ensure that analytical methods and instruments are accurate and meet GMP standards and requirements.

Author : Joachim Ermer,Phil W. Nethercote
Publisher : John Wiley & Sons
Page : 451 pages
File Size : 49,5 Mb
Release : 2014-11-10
Category : Medical
ISBN : 9783527335633

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Method Validation in Pharmaceutical Analysis by Joachim Ermer,Phil W. Nethercote Pdf

This second edition of a global bestseller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) and lifecycle concepts in pharmaceutical manufacturing. As in the first edition, the fundamental requirements for analytical method validation are covered, but the second edition describes how these are applied systematically throughout the entire analytical lifecycle. QbD principles require adoption of a systematic approach to development and validation that begin with predefined objectives. For analytical methods these predefined objectives are established as an Analytical Target Profile (ATP). The book chapters are aligned with recently introduced standards and guidelines for manufacturing processes validation and follow the three stages of the analytical lifecycle: Method Design, Method Performance Qualification, and Continued Method Performance Verification. Case studies and examples from the pharmaceutical industry illustrate the concepts and guidelines presented, and the standards and regulations from the US (FDA), European (EMA) and global (ICH) regulatory authorities are considered throughout. The undisputed gold standard in the field.

Author : Piotr Konieczka,Jacek Namiesnik
Publisher : CRC Press
Page : 325 pages
File Size : 45,9 Mb
Release : 2018-03-26
Category : Science
ISBN : 9781315294995

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Quality Assurance and Quality Control in the Analytical Chemical Laboratory by Piotr Konieczka,Jacek Namiesnik Pdf

The second edition defines the tools used in QA/QC, especially the application of statistical tools during analytical data treatment. Clearly written and logically organized, it takes a generic approach applicable to any field of analysis. The authors begin with the theory behind quality control systems, then detail validation parameter measurements, the use of statistical tests, counting the margin of error, uncertainty estimation, traceability, reference materials, proficiency tests, and method validation. New chapters cover internal quality control and equivalence method, changes in the regulatory environment are reflected throughout, and many new examples have been added to the second edition.

Author : Chung Chow Chan,Y. C. Lee,Herman Lam,Xue-Ming Zhang
Publisher : John Wiley & Sons
Page : 320 pages
File Size : 41,7 Mb
Release : 2004-04-23
Category : Science
ISBN : 9780471463719

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Analytical Method Validation and Instrument Performance Verification by Chung Chow Chan,Y. C. Lee,Herman Lam,Xue-Ming Zhang Pdf

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 and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.

Author : Ira R. Berry,Robert A. Nash
Publisher : CRC Press
Page : 658 pages
File Size : 40,6 Mb
Release : 1993-01-29
Category : Medical
ISBN : UOM:39015029467159

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Pharmaceutical Process Validation, Second Edition by Ira R. Berry,Robert A. Nash Pdf

The second edition of this text has been updated and enlarged to reflect current good manufacturing practice (CGMP) regulations and the increased interest in, and applicability of, process validation. "Pharmaceutical Process Validation" offers up-to-the-minute coverage of: regulations and validation; sterile process validation; organization in validation processes; solid dosage forms validation; raw material validation; analytical methods validation; and prospective and retrospective validation. Providing the contributions of leading experts in the field, the text also supplies examinations of current concepts in validation and new topics, such as: validation of cleaning systems and computer systems; equipment and water systems validation; and lyophilized and aerosol product validation.

Author : James O. Westgard,Patricia L. Barry,Elsa F. Quam
Publisher : Unknown
Page : 268 pages
File Size : 40,7 Mb
Release : 1999
Category : Medical
ISBN : CHI:54134046

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Basic Method Validation by James O. Westgard,Patricia L. Barry,Elsa F. Quam Pdf

Author : Robert McDowall
Publisher : Royal Society of Chemistry
Page : 290 pages
File Size : 42,7 Mb
Release : 2007-10-31
Category : Science
ISBN : 9781847552297

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Validation of Chromatography Data Systems by Robert McDowall Pdf

Chromatography is a major analytical technique that is used throughout research, development and manufacturing in the pharmaceutical, medical device and associated industries. To demonstrate fitness for purpose with the applicable regulations, the systems must be validated. Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements introduces the basics of computer validation. It looks in detail at the requirements throughout the life cycle of a CDS for any regulated laboratory, from its concept, through writing the user requirements specification to selecting the system, testing and operational release, including using electronic signatures. This logical and uniquely organised book provides the background to the regulatory requirements, interpretation of the regulations and documented evidence needed to support a claim that a system is validated. Development of the system, risk management, operation and finally system retirement and data migration are discussed. Case studies and practical examples are provided where appropriate. Validation of Chromatography Data Systems: Meeting Business and Regulatory Requirements is ideal for the chromatographer working in analytical laboratories in the regulated pharmaceutical, contract research, biotechnology and medical device industries seeking the practical guidance required for validating their chromatography data systems in order to meet regulatory requirements. It will also be welcomed by consultants or those in regulatory agencies.

Author : Anonim
Publisher : CRC Press
Page : 250 pages
File Size : 52,9 Mb
Release : 2016-04-19
Category : Science
ISBN : 9781420082715

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Quality Assurance and Quality Control in the Analytical Chemical Laboratory by Anonim Pdf

A Practical Tool for Learning New Methods Quality assurance and measurement uncertainty in analytical laboratories has become increasingly important. To meet increased scrutiny and keep up with new methods, practitioners very often have to rely on self-study. A practical textbook for students and a self-study tool for analytical laboratory employees, Quality Assurance and Quality Control in the Analytical Chemical Laboratory: A Practical Approach defines the tools used in QA/QC, especially the application of statistical tools during analytical data treatment. Unified Coverage of QA in Analytical Chemistry Clearly written and logically organized, this book delineates the concepts of practical QA/QC, taking a generic approach that can be applied to any field of analysis. Using an approach grounded in hands-on experience, the book begins with the theory behind quality control systems and then moves on to discuss examples of tools such as validation parameter measurements, the use of statistical tests, counting the margin of error, and estimating uncertainty. The authors draw on their experience in uncertainty estimation, traceability, reference materials, statistics, proficiency tests, and method validation to provide practical guidance on each step of the process. Extended Coverage of QC/QA in Analytical and Testing Laboratories Presenting guidance on all aspects of QA and measurement results, the book covers QC/QA in a more complex and extended manner than other books on this topic. This range of coverage supplies an integrated view on measures like the use of reference materials and method validation. With worked-out examples and Excel spreadsheets that users can use to try the concepts themselves, the book provides not only know-what but know-how.

Author : J. Dux
Publisher : Springer Science & Business Media
Page : 205 pages
File Size : 50,6 Mb
Release : 2013-11-11
Category : Medical
ISBN : 9781475753776

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Handbook of Quality Assurance for the Analytical Chemistry Laboratory by J. Dux Pdf

xii a second edition might be in order, and readily agreed. Although the basic principles remain the same, discussions with analysts, laboratory supervisors, and managers indicated many areas where improve ments could be made. For example, new chapters have been added on sampling and quality assurance; laboratory facilities and quality assurance; and auditing for quality assurance. Very little of the first edition has been discarded, but many topics have been expanded considerably. The chapter on computers has been completely rewritten in view of the rapid changes in that field. The chapter in the first edition on planning and organizing for quality assurance has been split into two chapters, one on planning for quality assurance and the other on organizing and establishing a quality assurance program, and new material on mandated quality assurance programs has been combined with the material on laboratory accreditation. Numerous examples, especially those involving mathematical calculations, have been added at the suggestion of some readers. In short, this edition is very nearly a new book, and I can only hope it is as well received as the first edition. CHAPTER 1 Quality, Quality Control, and Quality Assurance One of the strongest trends in modem society is the continuing ev olution from a manufacturing to a service-oriented economy.

Author : Bernd W. Wenclawiak,Michael Koch,Evsevios Hadjicostas
Publisher : Springer
Page : 611 pages
File Size : 55,5 Mb
Release : 2013-12-20
Category : Science
ISBN : 9783662096215

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Quality Assurance in Analytical Chemistry by Bernd W. Wenclawiak,Michael Koch,Evsevios Hadjicostas Pdf

Quality Assurance in Chemical Measurement, an advanced EURACHEM textbook, provides in-depth but easy-to-understand coverage for training, teaching and continuing studies. The CD-ROM accompanying the book contains course materials produced by ten experienced specialists, including more than 750 overheads (graphics and text) in ready-to-use PowerPoint® documents in English and German language. The book will serve as an advanced textbook for analytical chemistry students and professionals in industry and service labs and as a reference text and source of course materials for lecturers. The second edition has been completely revised according to the newest legislation.

Author : Ludwig Huber
Publisher : CRC Press
Page : 268 pages
File Size : 53,6 Mb
Release : 2023-04-28
Category : Science
ISBN : 9781000948226

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Validation of Computerized Analytical Systems by Ludwig Huber Pdf

Validation of Computerized Analytical and Networked Systems provides the definitive rationales, logic, and methodology for validation of computerized analytical systems. Whether you are involved with formulation or analytical development laboratories, chemical or microbiological quality control laboratories, LIMS installations, or any aspect of robotic in a healthcare laboratory, this book furnishes complete validation details. International and FDA regulations and requirements are discussed and juxtaposed with numerous practical examples that show you how to cost-effectively and efficiently accomplish validation acceptable to FDA GCP/GLP/GMP, NAMAS, and EN45001 standards. The templates included provide documentation examples and the many checklists found throughout the book assure that all aspects of covered in a logical sequence. The chapters describe and explain such topics as the Product Life Cycle revalidation, change control, documentation requirements, qualifications, testing, data validation and traceability, inspection, SOPs, and many other that help streamline the validation process.

Author : Michael E. Swartz,Ira S. Krull
Publisher : CRC Press
Page : 95 pages
File Size : 44,9 Mb
Release : 2018-10-03
Category : Science
ISBN : 9781482229776

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Analytical Method Development and Validation by Michael E. Swartz,Ira S. Krull Pdf

Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.

Author : Michael E. Swartz,Ira S. Krull
Publisher : CRC Press
Page : 226 pages
File Size : 46,9 Mb
Release : 2012-04-24
Category : Science
ISBN : 9780824706890

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Handbook of Analytical Validation by Michael E. Swartz,Ira S. Krull Pdf

Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook: Contains practical, up-to-date guidelines for analytical method validation Summarizes the latest regulatory requirements for all aspects of method validation, even those coming from the USP, but undergoing modifications Covers development, optimization, validation, and transfer of many different types of methods used in the regulatory environment Simplifying the overall process of method development, optimization and validation, the guidelines in the Handbook apply to both small molecules in the conventional pharmaceutical industry, as well as well as the biotech industry.