Documentation Basics that Support Good Manufacturing Practices PDF Download
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Author: Carol DeSain
Publisher: Aster Publishing Corporation
ISBN: 9780943330303
Category : Medical
Languages : en
Pages : 88
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Book Description
The documentation system described in this text is designed to support Good Manufacturing Practices (GMP) in a medical manufacturing environment. However, the usefulness of the system can be extended to other areas of a corporation (development, clinicals, marketing, finance, as well as to many other unrelated, nonmedical industries). The principles & the decision making inherent in documentation system design remain the same, no matter what the product or business. The book describes the creation, use & control of the descriptive documents, data collection documents, numbering systems & data files that are appropriate for use in an industry subject to Good Manufacturing Practices. The text was written as a guideline for the individuals who must design the systems & work with them routinely. The descriptive documents presented in this book are designed to serve two purposes: to direction task-specific events & to educate the reader about the event in a manner that supports responsible decision making. It presents the major components of a GMP documentation system, gives examples of design, format & content, & explains how these components interact. $US42.95 plus shipping & tax where applicable. Call or write Advanstar Communications, Marketing Services; 7500 Old Oak Boulevard; Cleveland, OH 44130. 216-826-2839 or 800-598-6008.
Author: Carol DeSain
Publisher: Aster Publishing Corporation
ISBN: 9780943330303
Category : Medical
Languages : en
Pages : 88
Get Book Here
Book Description
The documentation system described in this text is designed to support Good Manufacturing Practices (GMP) in a medical manufacturing environment. However, the usefulness of the system can be extended to other areas of a corporation (development, clinicals, marketing, finance, as well as to many other unrelated, nonmedical industries). The principles & the decision making inherent in documentation system design remain the same, no matter what the product or business. The book describes the creation, use & control of the descriptive documents, data collection documents, numbering systems & data files that are appropriate for use in an industry subject to Good Manufacturing Practices. The text was written as a guideline for the individuals who must design the systems & work with them routinely. The descriptive documents presented in this book are designed to serve two purposes: to direction task-specific events & to educate the reader about the event in a manner that supports responsible decision making. It presents the major components of a GMP documentation system, gives examples of design, format & content, & explains how these components interact. $US42.95 plus shipping & tax where applicable. Call or write Advanstar Communications, Marketing Services; 7500 Old Oak Boulevard; Cleveland, OH 44130. 216-826-2839 or 800-598-6008.
Author: Carol DeSain
Publisher: Advanstar Marketing Services
ISBN: 9780929870625
Category : Manufactures
Languages : en
Pages : 0
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Book Description
Author: William J. Mead
Publisher: CRC Press
ISBN: 1420077414
Category : Medical
Languages : en
Pages : 314
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Book Description
Dietary Supplement GMP is a one-stop "how-to" road map to the final dietary supplement GMP regulations recently issued by the FDA covering the manufacture, packaging, and holding of dietary supplement products.The recent regulations, outlining broad goals, intentionally avoid specifics to allow for future technological advances-leaving implementati
Author: Raymond Kimber
Publisher: CRC Press
ISBN: 9780824793562
Category : Technology & Engineering
Languages : en
Pages : 848
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Book Description
"Affords an advantageous understanding of contemporary management and total quality systems without excessive employment of advanced mathematics--directing managers in the implementation of the basic quality framework that will lead to improved production and increased profits through sound quality practices. Provides practical applications in a wide variety of industrial, financial, service, and administrative systems and shows how to prepare for quality audits, product meetings, and production discussions. Features 21 new chapters."
Author: Carol DeSain
Publisher: Addison Wesley Publishing Company
ISBN:
Category : Business & Economics
Languages : en
Pages : 456
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Book Description
Author: Andrew J. Fletcher
Publisher: John Wiley & Sons
ISBN: 0470851716
Category : Medical
Languages : en
Pages : 558
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Book Description
Principles and Practice of Pharmaceutical Medicine begins with a detailed overview of its origins, and goes on to examine current career opportunities, education and training. Encompassing the entire spectrum of pharmaceutical medicine, it also discusses international drug development and registration, including animal toxicology and human volunteers, pharmacoeconomics and statistics, medical services, legal and ethical issues and business aspects. It is the most up-to-date guide to drug development and marketing, and the only book with an international outlook. * The authors are all experts in their field and include an assessment of the current status of their specialities * This book provides an insight into how things may develop in the future * It is designed to be a guide for those who are actually practicing pharmaceutical medicine
Author: Syed Imtiaz Haider
Publisher: CRC Press
ISBN: 1420009419
Category : Medical
Languages : en
Pages : 1144
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Book Description
Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluati
Author: Mindy J. Allport-Settle
Publisher: Pharmalogika
ISBN: 9780982147603
Category : Law
Languages : en
Pages : 686
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Book Description
This title combines all of the human and veterinary Regulations, Directives and guidance for medicinal products used by the pharmaceutical industry as their main source when manufacturing and distributing medicinal products in the European Union.
Author: M. A. Vijayalakshmi
Publisher: CRC Press
ISBN: 1134491646
Category : Medical
Languages : en
Pages : 797
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Book Description
The field of bioseparation, and biochromatography in particular, is advancing very rapidly as our knowledge of the properties of molecules and atomic forces increases. This volume covers the basic principles of biochromatography in detail. It assesses different techniques and includes a large number of applications, providing the reader with a mult
Author: Shayne Cox Gad
Publisher: John Wiley & Sons
ISBN: 0470259809
Category : Science
Languages : en
Pages : 1386
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Book Description
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.
