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Author : ISPE
Publisher :
ISBN 13 : 9781931879255
Total Pages : 19 pages
Book Rating : 4.8/5 (792 download)
Download or read book GAMP Good Practice Guide written by ISPE and published by . This book was released on 2002 with total page 19 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 : 9781936379644
Total Pages : 136 pages
Book Rating : 4.3/5 (796 download)
Download or read book ISPE Baseline Pharmaceutical Engineering Guide for New and Renovated Facilities written by and published by . This book was released on 2013 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 : 9781931879095
Total Pages : 0 pages
Book Rating : 4.8/5 (79 download)
Download or read book Pharmaceutical Engineering Guides for New and Renovated Facilities written by and published by . This book was released on 1996 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Ispe
Publisher :
ISBN 13 : 9781946964052
Total Pages : 240 pages
Book Rating : 4.9/5 (64 download)
Download or read book ISPE Baseline® Guide written by Ispe and published by . This book was released on 2018-04-25 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Anton Bespalov
Publisher : Springer Nature
ISBN 13 : 3030336565
Total Pages : 424 pages
Book Rating : 4.0/5 (33 download)
Download or read book Good Research Practice in Non-Clinical Pharmacology and Biomedicine written by Anton Bespalov and published by Springer Nature. This book was released on 2020-01-01 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book, published under a CC BY 4.0 license in the Pubmed indexed book series Handbook of Experimental Pharmacology, provides up-to-date information on best practice to improve experimental design and quality of research in non-clinical pharmacology and biomedicine.
Author : David Roesti
Publisher : John Wiley & Sons
ISBN 13 : 1119356075
Total Pages : 594 pages
Book Rating : 4.1/5 (193 download)
Download or read book Pharmaceutical Microbiological Quality Assurance and Control written by David Roesti and published by John Wiley & Sons. This book was released on 2020-01-02 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks
Author : Shayne Cox Gad
Publisher : John Wiley & Sons
ISBN 13 : 0470259809
Total Pages : 1386 pages
Book Rating : 4.4/5 (72 download)
Download or read book Pharmaceutical Manufacturing Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-03-11 with total page 1386 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.
Author : Sion Wyn
Publisher :
ISBN 13 : 9781931879613
Total Pages : 0 pages
Book Rating : 4.8/5 (796 download)
Download or read book GAMP 5 written by Sion Wyn and published by . This book was released on 2008 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: GAMP 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. This technical document describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification. It points to the future of computer systems compliance by centering on principles behind major industry developments such as PQLI; ICH Q8, Q9, Q10; and ASTM E2500. This revolutionary Guide addresses the entire lifecycle of an automated system and its applicability to a wide range of information systems, lab equipment, integrated manufacturing systems, and IT infrastructures. It contains new information on outsourcing, electronic batch recording, end user applications (such as spreadsheets and small database applications), and patch management.
Author : Ispe
Publisher :
ISBN 13 : 9781931879729
Total Pages : pages
Book Rating : 4.8/5 (797 download)
Download or read book ISPE Baseline® Guide written by Ispe and published by . This book was released on 2010-01-25 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : CCPS (Center for Chemical Process Safety)
Publisher : John Wiley & Sons
ISBN 13 : 1118009002
Total Pages : 244 pages
Book Rating : 4.1/5 (18 download)
Download or read book Guidelines for Process Safety in Bioprocess Manufacturing Facilities written by CCPS (Center for Chemical Process Safety) and published by John Wiley & Sons. This book was released on 2011-12-28 with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book helps advance process safety in a key area of interest. Currently, no literature exists which is solely dedicated to process safety for the bioprocessing industry. There are texts, guidelines, and standards on biosafety at the laboratory level and for industrial hygiene, but no guidelines for large-scale production facilities. In fact, biosafety is largely defined as a field that promotes safe laboratory practices, procedures and use of containment equipment and facilities. Additionally, biomedical engineers, biologists, or other professionals without chemical engineering training or knowledge of inherently safe design are designing many of these facilities.
Author : Ispe
Publisher :
ISBN 13 : 9781946964144
Total Pages : 148 pages
Book Rating : 4.9/5 (641 download)
Download or read book ISPE Good Practice Guide written by Ispe and published by . This book was released on 2019-01-24 with total page 148 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Glyn N. Stacey
Publisher : John Wiley & Sons
ISBN 13 : 9780470723784
Total Pages : 696 pages
Book Rating : 4.7/5 (237 download)
Download or read book Medicines from Animal Cell Culture written by Glyn N. Stacey and published by John Wiley & Sons. This book was released on 2007-06-29 with total page 696 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medicines from Animal Cell Culture focuses on the use of animal cell culture, which has been used to produce human and veterinary vaccines, interferon, monoclonal antibodies and genetically engineered products such as tPA and erythropoietin. It also addresses the recent dramatic expansion in cell-based therapies, including the use of live cells for tissue regeneration and the culture of stem cells. Medicines from Animal Cell Culture: Provides comprehensive descriptions of methods for cell culture and nutrition as well as the technologies for the preservation and characterisation of both the cells and the derived products Describes the preparation of stem cells and others for use in cell-based therapies – an area of burgeoning research Includes experimental examples to indicate expected results Covers regulatory issues from the UK, the EU and the USA and reviews how these are developing around the world Addresses the key issues of standardisation and validation with chapters on GLP and GMP for cell culture processes Delivering insight into the exciting world of biological medicines and directions for further investigation into specific topics, Medicines from Animal Cell Culture is an essential resource for researchers and technicians at all levels using cell culture within the pharmaceutical, biotechnology and biomedical industries. It is of value to laboratory managers in these industries and to all those interested in this topic alike.
Author : Paul T. Anastas
Publisher :
ISBN 13 :
Total Pages : 216 pages
Book Rating : 4.3/5 (91 download)
Download or read book Benign by Design written by Paul T. Anastas and published by . This book was released on 1994 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: Describes the current status and potential of synthetic chemistry designed to use and to generate fewer hazardous substances. Examines new techniques for carrying out transformations in environmentally benign solvent systems. Presents research results on the replacement of hazardous feedstocks with biologically derived, innocuous feedstocks; of hazardous reagents with visible light; and of phosgene, benzene, and halogens in a variety of industrially important reactions. Provides examples of how alternative synthetic design for pollution prevention has been made commercially viable. Describes how to conduct a source-reduction assessment and analyzes computer-assisted synthetic design.
Author : Terry Jacobs
Publisher : CRC Press
ISBN 13 : 1482258919
Total Pages : 535 pages
Book Rating : 4.4/5 (822 download)
Download or read book Good Design Practices for GMP Pharmaceutical Facilities written by Terry Jacobs and published by CRC Press. This book was released on 2016-08-19 with total page 535 pages. Available in PDF, EPUB and Kindle. Book excerpt: This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.
Author : International Society for Pharmaceutical Engineering
Publisher :
ISBN 13 : 9781936379088
Total Pages : 116 pages
Book Rating : 4.3/5 (79 download)
Download or read book ISPE Guide written by International Society for Pharmaceutical Engineering and published by . This book was released on 2011 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : David J. am Ende
Publisher : John Wiley & Sons
ISBN 13 : 1118088107
Total Pages : 1431 pages
Book Rating : 4.1/5 (18 download)
Download or read book Chemical Engineering in the Pharmaceutical Industry written by David J. am Ende and published by John Wiley & Sons. This book was released on 2011-03-10 with total page 1431 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book deals with various unique elements in the drug development process within chemical engineering science and pharmaceutical R&D. The book is intended to be used as a professional reference and potentially as a text book reference in pharmaceutical engineering and pharmaceutical sciences. Many of the experimental methods related to pharmaceutical process development are learned on the job. This book is intended to provide many of those important concepts that R&D Engineers and manufacturing Engineers should know and be familiar if they are going to be successful in the Pharmaceutical Industry. These include basic analytics for quantitation of reaction components– often skipped in ChE Reaction Engineering and kinetics books. In addition Chemical Engineering in the Pharmaceutical Industry introduces contemporary methods of data analysis for kinetic modeling and extends these concepts into Quality by Design strategies for regulatory filings. For the current professionals, in-silico process modeling tools that streamline experimental screening approaches is also new and presented here. Continuous flow processing, although mainstream for ChE, is unique in this context given the range of scales and the complex economics associated with transforming existing batch-plant capacity. The book will be split into four distinct yet related parts. These parts will address the fundamentals of analytical techniques for engineers, thermodynamic modeling, and finally provides an appendix with common engineering tools and examples of their applications.
Author : Ispe
Publisher :
ISBN 13 : 9781936379934
Total Pages : 178 pages
Book Rating : 4.3/5 (799 download)
Download or read book ISPE Baseline® Guide written by Ispe and published by . This book was released on 2017-08-02 with total page 178 pages. Available in PDF, EPUB and Kindle. Book excerpt:
