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:
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Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers
Manufacturer: Informa Healthcare
ProductGroup: Book
Binding: Hardcover
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ASIN: 1574911171
Release Date: 2004-04-28 |
Book Description
One of the biggest computer validation challenges facing pharmaceutical manufacturers is the large corporate system. This book provides practical information and advice on good IT practice and validation principles. Written by experts, it includes case studies on EDMSs, EAM systems, LIMSs, and MRP II systems. Topics include paper- and peopleless plants, GxP compliance, integrating manufacturing systems, electronic signatures, validating asset management systems, enterprise/manufacturing planning systems, lab information management systems, and Local & Wide Area Networks, compliance for IT Infrastructure, IT system maintenance and support, and auditing suppliers, software Integrators, and hardware manufacturers.
Customer Reviews:
Useful case Studies.......2002-06-20
Very good chapter on operation and maintenance of large IT systems for FDA compliance. Latest GAMP case study on IT infrastructure. Excellent case study on networks.
Book Description
Providing a well-written and easy-to-read review of the subject, this reference describes the most recent breakthroughs in the validation and execution of testing schemes for parenteral quality control. Emphasize testing methodologies for the evaluation of package integrity, finished product contamination, and sterility, the book is a guide to testing and assuring that products for injecting drugs are sterile, free from pyrogenicity, and free from particulate matter. The authors highlight methods that meet US and European standards, explain regulatory requirements and harmonization between various authorities, and review trends and recent developments in technology.
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Essentials of drug product quality: Concepts and methodology
Mahmoud M Abdel-Monem
Manufacturer: Mosby
ProductGroup: Book
Binding: Unknown Binding
Pharmacology
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ASIN: 0801600316 |
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Quality Control in Pharmaceutical Analysis
Manufacturer: Elsevier Science
ProductGroup: Book
Binding: Hardcover
Quality Control
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Analytic
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General & Reference
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ASIN: 0444828761 |
Book Description
It is difficult, if not impossible, to visualize pharmaceutical industry processes without appropriate analytical control, of which chromatographic and, more recently, capillary electromigration techniques constitute a considerable proportion. Problems such as deciding which separation technique will be the best, whether a chromatographic or an electrokinetically driven method is preferred, calibration procedures and method validation, identification of impurities by on-line hyphenation with techniques based on physicochemical principles other than chromatography and electrophoresis and assaying of basic physicochemical properties are all to be solved by the analytical chemist. Unintended errors can occur quite frequently.
This volume covers all the above outlined areas, emphasizing those which the authors know from pharmaceutical research to cause problems in practice. The basic guidelines have been summarized along with the necessary theoretical background to help analysts select and apply modern chromatographic and electrokinetic methods of analysis in drug production and quality control and help them solve their particular problems.
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Quality Management of Nutraceuticals (Acs Symposium Series)
Chi-Tang Ho , and
Qun Yi Zheng
Manufacturer: An American Chemical Society Publication
ProductGroup: Book
Binding: Hardcover
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Accessories:
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Airborne Effervescent Health Formula, Original Orange, 10 Tablets (Pack of 3)
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Tanita BC533 Glass Innerscan Body Composition Monitor
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RESPeRATE Blood Pressure Lowering Device
ASIN: 0841237735 |
Book Description
The market of nutraceuticals, functional foods, and food supplements is a growing field due to consumer concerns and awareness of health. However, the quality of the products in the field is not well controlled. This volume examines the chemical and biological quality management of nutraceuticals and is divided into three sections. The first provides an overview on the topic and reviews several important classes of nutraceutical compounds, flavonoids, anthocyanins, and marine nutraceuticals. Examples of the chemical analysis of several nutraceutical products on the market such as goldenseal, saw palmetto, green tea, cocoa, and black cohosh are discussed in the second section of the volume. The final section gives the bioactivity of several nutraceutical products such as ginger and gum guggal.
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Design changes snare 4 device firms; one cited for not doing risk analysis.(Brief Article): An article from: Validation Times
Manufacturer: Washington Information Source
ProductGroup: Book
Binding: Digital
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ASIN: B0008JCVW8
Release Date: 2005-07-28 |
Book Description
This digital document is an article from Validation Times, published by Washington Information Source on September 1, 2000. The length of the article is 634 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.
Citation Details
Title: Design changes snare 4 device firms; one cited for not doing risk analysis.(Brief Article)
Publication:
Validation Times (Newsletter)
Date: September 1, 2000
Publisher: Washington Information Source
Volume: 2
Issue: 9
Page: NA
Article Type: Brief Article
Distributed by Thomson Gale
Book Description
This digital document is a journal article from Analytica Chimica Acta, published by Elsevier in 2004. The article is delivered in HTML format and is available in your Amazon.com Media Library immediately after purchase. You can view it with any web browser.
Description:
A liquid chromatographic (LC) technique coupled with photodiode array (PDA) detection was developed for determining daphnetin in extracts of Daphne tangutica and its medicinal preparation. The optimized method was achieved for the separation and detection of selected constituent using methanol-0.5% phosphonic acid as the mobile phase at a flow rate of 0.8mLmin^-^1, and 325nm as the detection wavelength. Daphnetin showed good linearity in a relatively wide concentration range (r > 0.999). Intra- and inter-assay accuracy and precision were all lower than 5.0%. Sample extracting and purifying procedures were intensively explored. The recovery of the method was 94.8%-105.0% with a relative standard deviation (R.S.D.) of 4.0%. The concentration of daphnetin in D. tangutica from different locations and in its medicinal preparation manufactured by different factories was quite different. The current method may serve as a valuable tool for quality control of D. tangutica and its preparation.
Book Description
This digital document is an article from Validation Times, published by Washington Information Source on November 1, 1999. The length of the article is 2526 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.
Citation Details
Title: HACCP seen as way to thwart bugs, but monitoring still king.(Hazard Analysis Critical Control Points)(Brief Article)
Publication:
Validation Times (Newsletter)
Date: November 1, 1999
Publisher: Washington Information Source
Volume: 1
Issue: 8
Page: NA
Article Type: Brief Article
Distributed by Thomson Gale
Book Description
This digital document is an article from Validation Times, published by Washington Information Source on December 1, 1999. The length of the article is 768 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.
Citation Details
Title: Preconfigured SAP systems seen speeding validation (2).(sampling and analysis plan)(Brief Article)
Author: Peter Dechnik
Publication:
Validation Times (Newsletter)
Date: December 1, 1999
Publisher: Washington Information Source
Volume: 1
Issue: 9
Page: NA
Article Type: Brief Article, Interview
Distributed by Thomson Gale
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Geochemistry of Strata-Bound Deposit in China (A series of solid earth sciences research in China)
Manufacturer: Science Pr
ProductGroup: Book
Binding: Hardcover
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Prospecting & Mining
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ASIN: 7030055306 |
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Geochemistry of Strata-bound Deposits in China
Manufacturer: Brill Academic Publishers
ProductGroup: Book
Binding: Hardcover
General
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Geochemistry
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ASIN: 9067642312 |
Book Description
These autobiographical and analytical essays by a diverse group of professors and graduate students from working-class families reveal an academic world in which "blue-collar work is invisible." Describing conflict and frustration, the contributors expose a divisive middle-class bias in the university setting. Many talk openly about how little they understood about the hierarchy and processes of higher education, while others explore how their experiences now affect their relationships with their own students. They all have in common the anguish of choosing to hide their working-class background, to keep the language of home out of the classroom and the ideas of school away from home. These startlingly personal stories highlight the fissure between a working-class upbringing and the more privileged values of the institution.
Customer Reviews:
Voices to be heard.......2001-05-02
I read a selection from this book for a class, which prompted me to read the rest of the book. Really interesting narratives written by a number of first generation university students from a number of races and cultures, all from working class backgrounds.
A common theme is the feeling of living in two worlds - home and school - worlds which seldom intersect. Students speak of trying to fit in with peers who were more well off, explaining why they didn't have money to go out on the weekend, or why they couldn't attend various events or spring break flings because they had to work.
Entitlement - not quite feeling like they belonged at the university... watching peers walk around like they owned the place and were born to it.
Identity - being changed by the college experience, and wondering how the experience would change their relationship with family/community who seemed, by comparison, so unchanged. Several spoke of becoming bi-lingual - speaking one way at the university and another at home. Communication styles that were vital to being understood and accepted both places.
The irony of higher education being such a point of pride for the family, who made huge sacrifices for the student to be the first in the family - not knowing that the college experience would potentially pull the student away from identifying with that family/community working-class culture.
University values - While schools are at least talking about racial unity, there was less attention given to class unity. Many struggled with the idea that the whole purpose of getting a university education was to "get a brighter future", a "better opportunity", to "escape" having to work a blue collar job. If blue collar is who I am and who my famliy is, why is that something to escape? These were conflicting messages for many... be inclusive and sensitive to differences, but the white collar world is a higher, more worthy pursuit.
The only reason I gave it 4 out of 5 stars is the length of the book. The narrative format is engaging, but I felt the collection was a little lengthy to hold my interest through the entire book because the themes were repeated quite often in each narrative. Still worth the read, this perspective needs to be heard!
Average customer rating:
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So This Is College
Nova Writer
Manufacturer: Lulu.com
ProductGroup: Book
Binding: Paperback
General
| Literature & Fiction
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| Classics
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| Literary
ASIN: 1411629949 |
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So This is College
Paul H. Landis
Manufacturer: New York: McGraw-Hill Book Company Inc. 1954
ProductGroup: Book
Binding: Hardcover
ASIN: B000LVNW62 |
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So This Is College?
Manufacturer: Mad Dog Pub. Co.
ProductGroup: Book
Binding: Paperback
Comic
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United States
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ASIN: 0965597423 |
Book Description
In this book you will find 10 short stories written by college students across the country based on their experiences going through University or Art school programs. While the locations are different and the voices all textured individually, the stories in this book are about the kinds of things you can actually expect from your own college experiences: from battling the dormitory bathrooms to studying for finals. These stories range from laugh out loud funny to profoundly heartwarming. A joy for anyone to read, and an excellent gift!
Book Description
This digital document is an article from The Sporting News, published by Sporting News Publishing Co. on April 15, 2005. The length of the article is 841 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.
Citation Details
Title: Felton dared to dream big: ok, so I'm a sucker for little guys, but hear me out on this one.(Raymond Felton)
Author: Dave Kindred
Publication:
The Sporting News (Magazine/Journal)
Date: April 15, 2005
Publisher: Sporting News Publishing Co.
Volume: 229
Issue: 15
Page: 72(1)
Distributed by Thomson Gale
Book Description
This digital document is an article from The Sporting News, published by Sporting News Publishing Co. on March 25, 2005. The length of the article is 907 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.
Citation Details
Title: How do you spell APR? C-h-e-a-t: so the NCAA has this grand plan for academic reform. Hey, how about, NCAA reform?(College Football)
Author: Matt Hayes
Publication:
The Sporting News (Magazine/Journal)
Date: March 25, 2005
Publisher: Sporting News Publishing Co.
Volume: 229
Issue: 12
Page: 58(1)
Distributed by Thomson Gale
Book Description
This digital document is an article from College Student Journal, published by Thomson Gale on March 1, 2007. The length of the article is 1056 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.
Citation Details
Title: "I've studied so hard for this course, but don't get it!" Differences between student and faculty perceptions.
Author: Douglas J. Lynch
Publication:
College Student Journal (Magazine/Journal)
Date: March 1, 2007
Publisher: Thomson Gale
Volume: 41
Issue: 1
Page: 22(3)
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Book Description
This digital document is an article from The Register-Guard (Eugene, OR), published by Thomson Gale on September 22, 2006. The length of the article is 1146 words. The page length shown above is based on a typical 300-word page. The article is delivered in HTML format and is available in your Amazon.com Digital Locker immediately after purchase. You can view it with any web browser.
Citation Details
Title: Money measures vie for votes this fall.(Government)(With so many to consider, voters usually are inclined to say no, but at least one pollster is optimistic)
Author: Gale Reference Team
Publication:
The Register-Guard (Eugene, OR) (Newspaper)
Date: September 22, 2006
Publisher: Thomson Gale
Page: A1
Distributed by Thomson Gale
Average customer rating:
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So This Is College Too
Marlene F. Blumin
Manufacturer: Kendall/Hunt Publishing Company
ProductGroup: Book
Binding: Paperback
General
| Education
| Nonfiction
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Student Life
| College & University
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ASIN: 0840386648 |
Books:
- Analytical Ultracentrifugation of Polymers and Nanoparticles (Springer Laboratory)
- Asymmetric Organocatalysis: From Biomimetic Concepts to Applications in Asymmetric Synthesis
- Bailey's Industrial Oil and Fat Products, 6 Volume Set
- Biochemistry of Lipids, Lipoproteins and Membranes, 4th edition (New Comprehensive Biochemistry) (New Comprehensive Biochemistry)
- Charge and Energy Transfer Dynamics in Molecular Systems: A Theoretical Introduction
- Chemistry Builder for Admission and Standardized Tests (Test Preps)
- Chemistry for Today: General, Organic, and Biochemistry
- Chemistry Success in 20 Minutes a Day (Skill Builders Series)
- Chemometric Techniques for Quantitative Analysis
- Coating and Drying Defects: Troubleshooting Operating Problems (Society of Plastics Engineers Monographs)
Books Index
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- Supernovae and Nucleosynthesis
- Return with Honor
- Reading a Japanese Film: Cinema in Context
- Internet Art: The Online Clash of Culture and Commerce
- With the Armies of the Tsar
Analytical Method Validation and Instrument Performance Verification
Analytical Method Development and Validation
Method Validation in Pharmaceutical Analysis: A Guide to Best Practice
Practical HPLC Method Development, 2nd Edition
Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form
![Determination of daphnetin in Daphne tangutica and its medicinal preparation by liquid chromatography [An article from: Analytica Chimica Acta]](http://ec1.images-amazon.com/images/I/11X3K2HNNQL.jpg)
