Validation of Chromatography Data Systems

Validation of Chromatography Data Systems Author Robert McDowall
ISBN-10 9781847552297
Release 2007-10-31
Pages 290
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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.

Validation of Chromatography Data Systems

Validation of Chromatography Data Systems Author Robert D. McDowall
ISBN-10 9781849736626
Release 2016-11-25
Pages 733
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Guiding chromatographers working in regulated industries and helping them to validate their chromatography data systems to meet data integrity, business and regulatory needs. This book is a detailed look at the life cycle and documented evidence required to ensure a system is fit for purpose throughout the lifecycle. Initially providing the regulatory, data integrity and system life cycle requirements for computerised system validation, the book then develops into a guide on planning, specifying, managing risk, configuring and testing a chromatography data system before release. This is followed by operational aspects such as training, integration and IT support and finally retirement. All areas are discussed in detail with case studies and practical examples provided as appropriate. The book has been carefully written and is right up to date including recently released FDA data integrity guidance. It provides detailed guidance on good practice and expands on the first edition making it an invaluable addition to a chromatographer’s book shelf.

Pharmaceutical Computer Systems Validation

Pharmaceutical Computer Systems Validation Author Guy Wingate
ISBN-10 9781420088953
Release 2016-04-19
Pages 798
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Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system. Key topics in Pharmaceutical Computer Systems Validation, Second Edition include: GAMP5, ASTM 2500, EU GMP (Annex 11), and US GMP revisions to regulatory requirements for electronic records and signatures that should be published in 2008 ICH Guidance Q8, Q9, and Q10 expectations FDA cGMPs for the 21st Century Initiative and associated guidance PIC/S Guidance on Good Practice for Computerized Systems in GxP Environments WK9864 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment the indirect developments from FDA/EU/Japan regulators and industry the role of QA department, and internal and external suppliers the integration of computer systems validation into single overall approach for wider system practical guidance on handling common high, medium, and low risk issues that can occur during the life cycle of a computer system managing outsource partners and handling legacy systems topical issues uncovered by regulatory authorities including US FDA

Chromatographic Integration Methods

Chromatographic Integration Methods Author Norman Allen Dyson
ISBN-10 0854045104
Release 1998-01-01
Pages 201
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This is an excellent source book for those who wish to increase their understanding of integrators.

Data Analysis and Signal Processing in Chromatography

Data Analysis and Signal Processing in Chromatography Author A. Felinger
ISBN-10 0080525563
Release 1998-05-19
Pages 413
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This book gives an overview of the numerical data analysis and signal treatment techniques that are used in chromatography and related separation techniques. Emphasis is given to the description of the symmetrical and asymmetrical chromatographic peak shape models. Both theoretical and empirical models are discussed. The fundamentals of data acquisition, types and effect of baseline noise, and methods of improving the signal-to-noise ratio (either in time or in frequency and wavelet domain) are thoroughly discussed. Resolution enhancement techniques, such as curve fitting, deconvolution by Fourier and wavelet transforms, iterative deconvolution, Kalman filtering and multivariate methods of curve resolution are all discussed with several chromatographic examples. Quantitative analysis by peak area of peak height measurement, the precision and accuracy of the quantitation of stand-alone or overlapping and symmetrical or asymmetrical peaks are treated. In a separate chapter, guidelines are given for the use of transform techniques for the analysis of chromatograms. A statistical description of peak overlap is given in the final chapters. Since the concept of resolution has to be reconsidered when one separates complex mixtures, the problem of resolution and overlap is quantitatively discussed by means of statistical methods, and by using Fourier analysis of the complex chromatogram. Features of this book • The ultimate source of numerical techniques to enhance chromatographic data • Gives a detailed description of signal and resolution enhancement techniques in a manner applicable for enhancing not only chromatography, but also spectroscopic and other analytical signals • The first book with a thorough overview of the statistics of peak overlap. This is the first volume to encompass both the simple and more sophisticated methods for the numerical treatment of chromatograms. It is, therefore, the fundamental resource of numerical analysis methods for every analyst.

Method Validation in Pharmaceutical Analysis

Method Validation in Pharmaceutical Analysis Author Joachim Ermer
ISBN-10 9783527672189
Release 2014-08-27
Pages 440
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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.

Der HPLC Experte II

Der HPLC Experte II Author Stavros Kromidas
ISBN-10 9783527687763
Release 2015-03-09
Pages 240
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Wie nutze ich die M?glichkeiten meiner HPLC/UHPLC-Anlage optimal, wo sind zur Zeit die Grenzen? Diese Frage wird in zweiten Band des HPLC-Experten in zw?lf Kapiteln - geschrieben von hochkar?tigen Spezialisten - kritisch aus unterschiedlichen Perspektiven beleuchtet. Komplement?r zum ersten Band werden typische Probleme und Fragen der Anwender wie Gradientenoptimierung und Kopplungstechniken behandelt. In kompakter Form wird gezeigt, wie die verschiedenen Ger?te f?r eine maximale Aufl?sung optimal genutzt werden k?nnen. Aber auch wie vorzugehen ist, wenn eher die Robustheit im Vordergrund steht. Praxisnah erf?hrt der erfahrene Leser welche M?glichkeiten ihm heute zur Verf?gung stehen aber auch wo die Grenzen einer modernen HPLC/UHPLC-Anlage liegen. Ein Handbuch von Praktikern f?r Praktiker.

Handbook of Analytical Validation

Handbook of Analytical Validation Author Michael E. Swartz
ISBN-10 9781420014488
Release 2012-04-24
Pages 220
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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.

Development And Validation Of Chromatographic Methods For Simultaneous Quantification Of Drugs In Bulk And In Their Formulations HPLC And HPTLC Techniques

Development And Validation Of Chromatographic Methods For Simultaneous Quantification Of Drugs In Bulk And In Their Formulations  HPLC And HPTLC Techniques Author Satish Y. Gabhe
ISBN-10 9783954893072
Release 2014-08
Pages 112
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This book details: 1. Development and validation of a HPTLC-densitometric method for concurrent estimation of metformin hydrochloride, pioglitazone hydrochloride and gliclazide in combined dosage form. 2. Development and validation of a HPTLC method for simultaneous estimation of moxifloxacin hydrochloride and dexamethasone sodium phosphate in combined pharmaceutical dosage form. 3. Development and validation of a RP-HPLC method for simultaneous estimation of ciprofloxacin hydrochloride and dexamethasone in combined dosage form, which is a better alternative to existing ones. The developed analytical methods are simple, selective, accurate, robust, and precise with shorter analysis time for the analysis of drug/s in combined pharmaceutical dosage forms. All the developed HPTLC and HPLC methods have been validated as per ICH Q2 (R1) guideline. Developed analytical methods could boost analytical researchers to work more efficiently in the field of analytical method development and validation of Pharmaceutical dosage forms.

American Laboratory

American Laboratory Author
ISBN-10 STANFORD:36105123651932
Release 2007
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American Laboratory has been writing in one form or another for most of life. You can find so many inspiration from American Laboratory also informative, and entertaining. Click DOWNLOAD or Read Online button to get full American Laboratory book for free.


Chemometrics Author David R. Burgard
ISBN-10 0849348641
Release 1990-08-27
Pages 208
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Ranging from elegantly simple to extremely complex, a wide variety of flavors and fragrances stimulate our senses. It is difficult to understand the myriad sensory interactions involved because of the sheer complexity of their chemical composition. The aim of this text is to describe the use of chemometric techniques for understanding these complex systems and to serve as a practical guide to the acquisition, organization and reduction of chemical and sensory data. It explains chemical, sensory and multivariate analysis tools and their application. Pertinent concepts are discussed in-depth and are sufficiently illustrated with enough original data in complementary tables and figures to provide the basis for the execution of complex studies. The book emphasizes techniques that have been proven to work rather than those that "should" work from a theoretical standpoint. The book focuses on the acquisition of quality data and the subsequent interpretation of data rather than numerical computations used in data analysis. Chemometrics: Chemical and Sensory Data is an excellent resource for students and newcomers to flavor and fragrance research, as well as for experienced workers and product development managers.

Das HPLC MS Buch f r Anwender

Das HPLC MS Buch f r Anwender Author
ISBN-10 9783527808052
Release 2017-06-15
Pages 258
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Aus einem Verfahren f?r Spezialisten in der Forschung hat sich die LC/MS-Kopplung zu einer bew?hrten Routineanwendung entwickelt. Ziel des Buchs ist, LC/MS-Anwendern m?glichst detaillierte Informationen zu geben, damit sie ihre LC/MS-Applikation optimal durchf?hren k?nnen. Nach einem ?berblick ?ber den gegenw?rtigen Stand der Technik und instrumentelle Voraussetzungen werden Aspekte der Methodenentwicklung diskutiert. Ein Kapitel mit Tipps und Tricks leitet zu Anwenderberichte ?ber, bei denen auch ein Blick ?ber die klassische HPLC hinaus zur Ionenchromatographie geworfen wird. Berichte von renommierten Ger?teherstellern ?ber neueste Entwicklungen runden das Buch ab. Dieses Praktikerbuch liefert LC/MS-Anwendern die Informationen, die sie zur optimalen Nutzung ihrer Ger?te ben?tigen: Von instrumentellen Voraussetzungen und Methodenentwicklung bis zu Anwender- und Herstellerberichten werden wichtige Themen kompakt auf den Punkt gebracht.

Gaschromatographie in Bildern

Gaschromatographie in Bildern Author Bruno Kolb
ISBN-10 9783527662951
Release 2012-05-11
Pages 255
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Die bew?hrte Einf?hrung in die Gaschromatographie von Bruno Kolb enth?lt jetzt auch einen Abschnitt ?ber die GC-MS-Kopplung. Praktiker, Studenten und Auszubildende k?nnen sich durch dieses Buch schnell und einfach mit der GC vertraut machen. Der Autor beschreibt neben den Grundlagen und Begriffen die Teile des GC-Systems (Injektionssysteme, Trenns?ulen und Detektoren), die zahlreichen M?glichkeiten der Probenaufgabe speziell f?r Kapillars?ulen, Betriebs-und Trennbedingungen, sowie ausf?hrlich die quantitative Auswertung. Aus Rezensionen der ersten Auflage "Dieses didaktisch und graphisch gut gestaltete Buch kann den Anwendern der Kapillar-GC w?rmstens empfohlen werden; es kann auch in der Ausbildung sehr gut eingesetzt werden." Chromatographia "Dem Autor ist es gelungen, ohne komplizierte Theorien zu beschreiben, in anschaulicher Weise pr?zise ?ber die wesentlichen Grundlagen der GC zu informieren. Herausragend ist dabei die Gegen?berstellung von verst?ndlichen Abbildungen mit dem dazugeh?rigen Text auf jeder Doppelseite des Buches. [...] Das Werk sollte deshalb in keinem GC-Labor fehlen und ist dem neuen Anwender oder den 'alten Hasen' ?u?erst zu empfehlen." Lebensmittelchemie ?ber den Autor: Bruno Kolb war lange Jahre in der Perkin-Elmer Firmengruppe als Leiter der GC-Anwendung t?tig und war massgeblich an der Entwicklung von GC-Detektoren und insbesondere der Headspace-Technik beteiligt. Er hat zahlreiche GC-Einf?hrungs- und Anwendungskurse gegeben, ist Herausgeber und Autor mehrerer B?cher sowie von ?ber 50 wissenschaftlichen und technischen Publikationen.

High Throughput Analysis for Early Drug Discovery

High Throughput Analysis for Early Drug Discovery Author James Kyranos
ISBN-10 0080472923
Release 2004-09-18
Pages 204
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High Throughput Analysis for Early Drug Discovery offers concise and unbiased presentations by synthetic and analytical chemists who have been involved in creating and moving the field of combinatorial chemistry into the academic and industrial mainstream. Since the synthetic method often dictates the appropriate types of analysis, each chapter or section begins with a description of the synthesis approach and its advantages. The description of various combinatorial and high-throughput parallel synthesis techniques provide a relevant point of entry for synthetic chemists who need to set up appropriate characterisation methods for his/her organisation. This is an invaluable resource for all organic and analytical chemists in the pharmaceutical, agrochemical, and biotechnology fields who are either involved in, or beginning to investigate combinatorial techniques to increase overall efficiency and productivity. First reference to focus on the analytical side of synthesis

Forensic Applications of High Performance Liquid Chromatography

Forensic Applications of High Performance Liquid Chromatography Author Shirley Bayne
ISBN-10 9781439882597
Release 2010-01-15
Pages 276
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Chromatography has many roles in forensic science, ranging from toxicology to environmental analysis. In particular, high-performance liquid chromatography (HPLC) is a primary method of analysis in many types of laboratories. Maintaining a balance between practical solutions and the theoretical considerations involved in HPLC analysis, Forensic Applications of High Performance Liquid Chromatography uses real-life examples likely to be found within a forensic science laboratory to explain HPLC from a forensic perspective. Focusing chiefly on the reverse phase HPLC mode of separation, this volume examines: The history of HPLC and the theory behind the separation process The requirements for successful analysis and best practice tips The modes of separation and detection most appropriate for forensic science applications HPLC method development and evaluation The quality aspects of laboratory operation Troubleshooting HPLC systems and analyses Applications of HPLC within the field of forensic science Designed as a textbook for university students studying analytical chemistry, applied chemistry, forensic chemistry, or other courses with an element of HPLC within the course curriculum, this volume is also an invaluable guide for those in the early stages of their forensic analysis careers. An instructor’s manual with lecture slides, test bank, objectives, and exercises is available with qualifying course adoption


LC GC Author
ISBN-10 UVA:X006001694
Release 1995
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LC GC has been writing in one form or another for most of life. You can find so many inspiration from LC GC also informative, and entertaining. Click DOWNLOAD or Read Online button to get full LC GC book for free.

Quality Today

Quality Today Author
ISBN-10 UOM:39015048298817
Release 1998
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Quality Today has been writing in one form or another for most of life. You can find so many inspiration from Quality Today also informative, and entertaining. Click DOWNLOAD or Read Online button to get full Quality Today book for free.