Book Description
How to hone your analytical skills and obtain high-quality data in the era of GMP requirements
With increased regulatory pressures on the pharmaceutical industry, there is a growing need for capable analysts who can ensure appropriate scientific practices in laboratories and manufacturing sites worldwide. Based on Johnson & Johnson's acclaimed in-house training program, this practical guide provides guidance for laboratory analysts who must juggle the Food and Drug Administration's good manufacturing practices (GMP) rules with rapidly changing analytical technologies. Highly qualified industry experts walk readers step-by-step through the concepts, techniques, and tools necessary to perform analyses in an FDA-regulated environment, including clear instructions on all major analytical chemical methods-from spectroscopy to chromatography to dissolution. An ideal manual for formal training as well as an excellent self-study guide, Analytical Chemistry in a GMP Environment features:
* The drug development process in the pharmaceutical industry
* Uniform and consistent interpretation of GMP compliance issues
* A review of the role of statistics and basic topics in analytical chemistry
* An emphasis on high-performance liquid chromatographic (HPLC) methods
* Chapters on detectors and quantitative analysis as well as data systems
* Methods for ensuring that instruments meet standard operating procedures (SOP) requirements
* Extensive appendixes for unifying terms, symbols, and procedural information
Customer Reviews:
A "real" practical book.......2004-07-01
This is the book if you work in the analytical lab of pharmaceutical industry. The book covers a lot of practical and day to day problems faced by persons working in the analytical lab especially from a regulatory point of view. Different chapters have been written by area experts making it very useful and comprehensive. I strongly recommend this book.
Average customer rating:
- Calculations: great work examples extracted from real-life chemical tests
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Statistics for the Quality Control Chemistry Laboratory
E. Mullins
Manufacturer: Royal Society of Chemistry
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Introduction to Statistical Quality Control
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The Craft of Scientific Presentations: Critical Steps to Succeed and Critical Errors to Avoid
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Kitchen Chemistry
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Food Science (Food Science Texts Series)
ASIN: 0854046712 |
Book Description
Statistical methods are essential tools for analysts, particularly those working in Quality Control Laboratories. This book provides a sound introduction to their use in analytical chemistry, without requiring a strong mathematical background. It emphasises simple graphical methods of data analysis, such as control charts, which are a key tool in Internal Laboratory Quality Control and which are also a fundamental requirement in laboratory accreditation. A large part of the book is concerned with the design and analysis of laboratory experiments, including sample size determination. Practical case studies and many real datasets, from both QC laboratories and the research literature, are used to illustrate the ideas in action.The aim of Statistics for the Quality Control Chemistry Laboratory is to give the reader a strong grasp of the concept of statistical variation in laboratory data and of the value of simple statistical ideas and methods in thinking about and manipulating such data. It will be invaluable to analysts working in QC laboratories in industry, hospitals and public health, and will also be welcomed as a textbook for aspiring analysts in colleges and universities.
Customer Reviews:
Calculations: great work examples extracted from real-life chemical tests.......2007-07-16
This is a great statistical text book to be used whenever a Chemist shall need to plan "how many number" of "N" the method validation study should at least cover via experimental studies; to compare present measurement results with the previous past results; to apply statistical techniques to constuct quality control chart. A reader friendly yet comprehensive statistical text book with lots of illustrated work examples dedicted to anyone working in the field of chemical testing.
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Quality Assurance in Analytical Chemistry: Applications in Environmental, Food and Materials Analysis, Biotechnology, and Medical Engineering
Werner Funk ,
Vera Dammann , and
Gerhild Donnevert
Manufacturer: Wiley-VCH
ProductGroup: Book
Binding: Hardcover
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ASIN: 3527311149 |
Book Description
This best-selling title both in German and English is now enhanced by a new chapter on the important topical subject of measurement uncertainty, plus a CD-ROM with interactive examples in the form of Excel-spreadsheets. These allow readers to gain an even better comprehension of the statistical procedures for quality assurance while also incorporating their own data.
Following an introduction, the text goes on to elucidate the 4-phase model of analytical quality assurance: establishing a new analytical process, preparative quality assurance, routine quality assurance and external analytical quality assurance.
Besides updating the relevant references, the authors took great care to incorporate the latest international standards in the field.
Note: CD-ROM/DVD and other supplementary materials are not included as part of eBook file.
Average customer rating:
- Best practical work on managing an analytical chemistry lab
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Managing the Analytical Laboratory: Plain and Simple
Clifford Nilsen
Manufacturer: CRC
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Binding: Loose Leaf
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Successful Management of the Analytical Laboratory
ASIN: 1574910159 |
Book Description
A clear, concise manual on how to run a quality control testing laboratory efficiently and in compliance with all regulations, this book provides hundreds of tips and techniques that help the reader focus on the essential elements of good laboratory management. It presents thirty-nine useful SOPs that have evolved from the author's years of practical experience. Fifteen case studies describe typical laboratory problems and offer possible solutions. From how to train analysts, to how to lay out the laboratory, to how to assure that samples are processed in a systematic manner, Managing the Analytical Laboratory: Plain and Simple covers it all.
Customer Reviews:
Best practical work on managing an analytical chemistry lab.......1998-07-16
Covers all aspects of running an analytical lab from daily operations to long-term planning. It is written in a down-to-earth chemist-to-chemist style that is concise and to the point. No theories or high-brow stuff; just plain common sense how-to-do-it techniques that work. This book is a fast read and can be used as a ready reference. It includes 39 laboratory standard operating procedures that can be used by the reader to enhance his or her laboratory operation and which serve as an additional teaching tool.
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Reference Materials in Analytical Chemistry: A Guide for Selection and Use (Springer Series in Materials Science)
Manufacturer: Springer
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Binding: Hardcover
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ASIN: 3540667768 |
Book Description
Under the guidance of the German Federal Institute for Materials Research (BAM), the standards for fabrication and application of reference materials are presented here in comprehensive form. The areas covered are analytical chemistry, materials science, environmental analysis, clinical and forensic toxicological analysis, and gas and food analysis. A standard reference for every analytical laboratory.
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Validation and Qualification in Analytical Laboratories
Ludwig Huber
Manufacturer: Informa Healthcare
ProductGroup: Book
Binding: Hardcover
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ASIN: 1574910809 |
Book Description
This complete guide and reference explains how to improve product quality while achieving compliance with the world's regulatory standards. It shows 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 readers through the validation process. 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.
Book Description
Quality assurance (QA) in chemical measurement is one of the major challenges in the work field of chemists. It is hard for the beginner to find information on all those topics related to QA. This book contains a compilation from different areas which deal with QA. Topics covered in this book include: Accreditation - ISO 17025, Certification - ISO 9000, Proficiency Testing, Basic Statistics, Measurement Uncertainty, Glossary / Institutions, Fit for the purpose (Philosophy), Quality Manual, Validation of Methods, Accreditation vs. Certification, GLP, Calibration - Detection Limit, Reference Materials, Control Charts, Metrology/Traceability, TQM and Cost of Quality.
Standards such as ISO 17025, accreditation, measurement uncertainty amongst many others are topics which are often not covered in university classes. Especially first time employees or those switching to the field of analytical chemistry measurements are stressed by many special terms and requirements, they have not heard of before. Sometimes it might be necessary to introduce other newcomers to the field with some startup information.
It is the aim of this book to give a help to get started. It provides basic information in all fields that are of interest for quality assurance in chemical measurement regarding management requirements as well as technical requirements. It is also very valuable for all those leaving the university, before they seek their first employment and to get ready for the job interview.
Electronic reading is supported by a CD which accompanies the book. Material provided thereon can be used as memory card or as ready to use transparencies for teaching purposes in educational institutions and for in-house training of the laboratory staff.
Specialists from different fields have contributed to this book sharing their expertise with the reader to get started in QA.
Average customer rating:
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Sample Handling and Trace Analysis of Pollutants (Techniques and Instrumentation in Analytical Chemistry)
D. Barceló
Manufacturer: Elsevier Science
ProductGroup: Book
Binding: Hardcover
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ASIN: 0444828311 |
Book Description
This book is an updated, completely revised version of a previous volume in this series entitled: ENVIRONMENTAL ANALYSIS -- Techniques, applications and quality assurance. The book treats different aspects of environmental analysis such as sample handling and analytical techniques, the applications to trace analysis of pollutants (mainly organic compounds), and quality assurance aspects, including the use of certified reference materials for the quality control of the whole analytical process. New analytical techniques are presented that have been developed significantly over the last 6 years, like solid phase microextraction, microwave-assisted extraction, liquid chromatography-mass spectrometric methods, immunoassays, and biosensors.
The book is divided into four sections. The first describes field sampling techniques and sample preparation in environmental matrices: water, soil, sediment and biota.
The second section covers the application areas which are either based on techniques, like the use of gas chromatography-atomic emission detection, immunoassays, or coupled-column liquid chromatography, or on specific application areas, like chlorinated compounds, pesticides, phenols, mycotoxins, phytotoxins, radionuclides, industrial effluents and wastes, including mine waste.
Validation and quality assurance are described in the third section, together with the interpretation of environmental data using advanced chemometric techniques.
The final section reports the use of somewhat advanced analytical methods, usually more expensive, less routinely used or less developed, for the determination of pollutants.
Average customer rating:
- Quality Assurance in the Analytical Chemistry Laboratory
|
Quality Assurance in the Analytical Chemistry Laboratory
D. Brynn Hibbert
Manufacturer: Oxford University Press, USA
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Binding: Paperback
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ASIN: 0195162137 |
Book Description
Analytical chemical results touch everyones lives can we eat the food? do I have a disease? did the defendant leave his DNA at the crime scene? should I invest in that gold mine? When a chemist measures something how do we know that the result is appropriate? What is fit for purpose in the context of analytical chemistry? Many manufacturing and service companies have embraced traditional statistical approaches to quality assurance, and these have been adopted by analytical chemistry laboratories. However the right chemical answer is never known, so there is not a direct parallel with the manufacture of ball bearings which can be measured and assessed. The customer of the analytical services relies on the quality assurance and quality control procedures adopted by the laboratory. It is the totality of the QA effort, perhaps first brought together in this text, that gives the customer confidence in the result. QA in the Analytical Chemistry Laboratory takes the reader through all aspects of QA, from the statistical basics and quality control tools to becoming accredited to international standards. The latest understanding of concepts such as measurement uncertainty and metrological traceability are explained for a working chemist or her client. How to design experiments to optimize an analytical process is included, together with the necessary statistics to analyze the results. All numerical manipulation and examples are given as Microsoft Excel spreadsheets that can be implemented on any personal computer. Different kinds of interlaboratory studies are explained, and how a laboratory is judged in proficiency testing schemes is described. Accreditation to ISO 17025 or OECD GLP is nearly obligatory for laboratories of any pretension to quality. Here the reader will find an introduction to the requirements and philosophy of accreditation. Whether completing a degree course in chemistry or working in a busy analytical laboratory, this book is a single source for an introduction into quality assurance.
Customer Reviews:
Quality Assurance in the Analytical Chemistry Laboratory.......2007-08-26
Very good book in the field of application.It is very importance in my country(Chile, Sud America)for the use in the Accreditation of the Laboratories in Analytical Chemistry
Average customer rating:
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Quality Control in Analytical Chemistry (Chemical Analysis: A Series of Monographs on Analytical Chemistry and Its Applications)
G. Kateman , and
L. Buydens
Manufacturer: Wiley-Interscience
ProductGroup: Book
Binding: Hardcover
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ASIN: 0471557773 |
Book Description
Describes the basics of analytical techniques, sampling and data handling in order to improve quality control in analytical laboratory management. Stresses what quality parameters can be improved and which ones should be rectified first. This edition includes numerous modern methods and the latest developments in time-proven techniques.
Customer Reviews:
A too much teorical book.......2000-06-13
Who consults the index of this book may be sure of finding there all the aspects of quality control,from quality assurance to mathematical aspects rarely found on books of this purpose (like "Data Filtering" or "Furrier Transforms of Data"). Whatever, all this mathematical aspects have their development of a very theorical way, with a very small number of examples. If we wish to tell in other way, this book is not an indicated one to implementation of a quality control, being in fact very mathematical "strong" in presentation of some concepts (always without examples). There's no necessity of demonstrations not even of mathematical integers even in the aplication of some advanced concepts of statistic. It has a good chapter about sampling, in the diverse phisical forms, and after a huge chapter about "data analisys" where, with so many themes and so mathematical material, none of them is very well explained making impossible any pratic aplication. A more correct name to this book would be "Further Analysis in Quality Control" or " Advanced Subjects in Quality Control." The sub-chapter about Filtration of Noise, between others, seems very mathematical being lots of others simpler aspects to ilustrate. For being a small book, even the complex is detailed.
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