analytical method validation and instrument performance verification

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Analytical Method Validation And Instrument Performance Verification

Author : Chung Chow Chan
ISBN : 047146371X
Genre : Science
File Size : 73. 5 MB
Format : PDF
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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.

Practical Approaches To Method Validation And Essential Instrument Qualification

Author : Chung Chow Chan
ISBN : 9781118060315
Genre : Science
File Size : 37. 5 MB
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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.

Validation Of Computerized Analytical And Networked Systems

Author : Ludwig Huber
ISBN : 1574911333
Genre : Medical
File Size : 26. 79 MB
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You cannot afford to be in the dark when it comes to validating your analytical systems and lab software. Written by international laboratory and compliance expert Dr. Ludwig Huber, Validation of Computerized Analytical and Networked Systems is an invaluable validation tool. Covering the initial writing of the validation plan through implementation, testing, and installation qualification, through ongoing calibration, performance qualification, and change control, the book provides guidance throughout the entire validation process. Huber pays special attention to 21CFR Part 11 electronic records and signatures compliance, including recommendations for implementation and the scope of Part 11 for chromatographic systems. He discusses vendor assessment, covers the criteria and procedures for vendor audits, and includes vendor assessment checklists. He also explores the validation of complex networked systems and "office software" such as Macros, spreadsheets, and databases, and the operational compliance of legacy systems. The book contains everything you need to perform computer systems validation cost-effectively and in a manner acceptable to national and international regulatory agencies.

Validation And Qualification In Analytical Laboratories Second Edition

Author : Ludwig Huber
ISBN : 084938267X
Genre : Medical
File Size : 76. 38 MB
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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.

Chemical Identification And Its Quality Assurance

Author : Boris L. Milman
ISBN : 9783642153617
Genre : Science
File Size : 82. 2 MB
Format : PDF, ePub
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This is the first book to show how to apply the principles of quality assurance to the identification of analytes (qualitative chemical analysis). After presenting the principles of identification and metrological basics, the author focuses on the reliability and the errors of chemical identification. This is then applied to practical examples such as EPA methods, EU, FDA, or WADA regulations. Two whole chapters are devoted to the analysis of unknowns and identification of samples such as foodstuffs or oil pollutions. Essential reading for researchers and professionals dealing with the identification of chemical compounds and the reliability of chemical analysis.

High Performance Thin Layer Chromatography Hptlc

Author : ManMohan Srivastava
ISBN : 3642140254
Genre : Science
File Size : 44. 99 MB
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The present edited book is the presentation of 18 in-depth national and international contributions from eminent professors, scientists and instrumental chemists from educational institutes, research organizations and industries providing their views on their experience, handling, observation and research outputs on HPTLC, a multi-dimensional instrumentation. The book describes the recent advancements made on TLC which have revolutionized and transformed it into a modern instrumental technique HPTLC. The book addresses different chapters on HPTLC fundamentals: principle, theory, understanding; instrumentation: implementation, optimization, validation, automation and qualitative and quantitative analysis; applications: phytochemical analysis, biomedical analysis, herbal drug quantification, analytical analysis, finger print analysis and potential for hyphenation: HPTLC future to combinatorial approach, HPTLC-MS, HPTLC-FTIR and HPTLC-Scanning Diode Laser. The chapters in the book have been designed in such away that the reader follows each step of the HPTLC in logical order.

Validation Of Analytical Methods For Pharmaceutical Analysis

Author : Oona McPolin
ISBN : 9780956152817
Genre : Medical
File Size : 36. 11 MB
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This book provides a comprehensive guide on validating analytical methods. Key features: Full review of the available regulatory guidelines on validation and in particular, ICH. Sections of the guideline, Q2(R1), have been reproduced in this book with the kind permission of the ICH Secretariat; Thorough discussion of each of the validation characteristics (Specificity; Linearity; Range; Accuracy; Precision; Detection Limit; Quantitation Limit; Robustness; System Suitability) plus practical tips on how they may be studied; What to include in a validation protocol with advice on the experimental procedure to follow and selection of appropriate acceptance criteria; How to interpret and calculate the results of a validation study including the use of suitable statistical calculations; A fully explained case study demonstrating how to plan a validation study, what to include in the protocol, experiments to perform, setting acceptance criteria, interpretation of the results and reporting the study.

Validation And Qualification In Analytical Laboratories

Author : Ludwig Huber
ISBN : 1574910809
Genre : Medical
File Size : 62. 35 MB
Format : PDF, ePub, Docs
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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.

Validation In Chemical Measurement

Author : Paul De Bièvre
ISBN : 3540207880
Genre : Science
File Size : 39. 37 MB
Format : PDF
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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 user of the measurement results.

Aldrich Advancing Science

Author :
ISBN : PSU:000055799454
Genre : Chemical laboratories
File Size : 33. 58 MB
Format : PDF, ePub
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