Full Read and Download Reference eBook
Documentation Basics That Support Good Manufacturing Practices Book in PDF, ePub and Kindle version is available to download in english. Read online anytime anywhere directly from your device. Click on the download button below to get a free pdf file of Documentation Basics That Support Good Manufacturing Practices book. This book definitely worth reading, it is an incredibly well-written.
Author : Carol DeSain
Publisher : Advanstar Marketing Services
Page : 0 pages
File Size : 12,26 MB
Release : 2001
Category : Manufactures
ISBN : 9780929870625
Author : Carol DeSain
Publisher : Aster Publishing Corporation
Page : 88 pages
File Size : 20,81 MB
Release : 1993-01-01
Category : Medical
ISBN : 9780943330303
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 : William J. Mead
Publisher : CRC Press
Page : 314 pages
File Size : 37,12 MB
Release : 2016-04-19
Category : Medical
ISBN : 1420077414
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
Page : 848 pages
File Size : 46,66 MB
Release : 1997-08-29
Category : Technology & Engineering
ISBN : 9780824793562
"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 : Philip Carson
Publisher : Royal Society of Chemistry
Page : 657 pages
File Size : 47,55 MB
Release : 2007-10-31
Category : Science
ISBN : 1847557724
Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included.
Author : Andrew J. Fletcher
Publisher : John Wiley & Sons
Page : 558 pages
File Size : 45,58 MB
Release : 2003-01-31
Category : Medical
ISBN : 0470851716
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
Page : 1144 pages
File Size : 32,38 MB
Release : 2006-05-30
Category : Medical
ISBN : 1420009419
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 : Carol DeSain
Publisher : Addison Wesley Publishing Company
Page : 456 pages
File Size : 21,34 MB
Release : 1993
Category : Business & Economics
ISBN :
Author : Behnam Davani
Publisher : John Wiley & Sons
Page : 211 pages
File Size : 35,88 MB
Release : 2017-08-01
Category : Science
ISBN : 1119425018
A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, Pharmaceutical Analysis for Small Molecules is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs. It features contributions by distinguished experts in the field, including editor and author, Dr. Behnam Davani, an analytical chemist with decades of technical management and teaching experience in compendial, regulatory, and industry. This book provides an introduction to pharmaceutical analysis for small molecules (non-biologics) using commonly used techniques for drug characterization and performance tests. The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. In addition, related required supporting studies including good laboratory/documentation practices including analytical instrument qualification are highlighted in this book. Topics covered include: Drug Approval Process and Regulatory Requirements (private standards) Pharmacopeias and Compendial Approval Process (public standards) Common methods in pharmaceutical analysis (typically compendial) Common Calculations for assays and impurities and other specific tests Analytical Method Validation, Verification, Transfer Specifications including how to handle out of specification (OOS) and out of trend (OOT) Impurities including organic, inorganic, residual solvents and elemental impurities Good Documentation Practices for regulatory environment Management of Analytical Laboratories Analytical Instrument Qualifications including IQ, OQ, PQ and VQ Due to global nature of pharmaceutical industry, other topics on both regulatory (ICH) and Compendial harmonization are also highlighted. Pharmaceutical Analysis for Small Molecules is a valuable working resource for scientists directly or indirectly involved with the drug development process, including analytical chemists, pharmaceutical scientists, pharmacists, and quality control/quality assurance professionals. It also is an excellent text/reference for graduate students in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.
Author : Gerardus Blokdyk
Publisher : 5starcooks
Page : 308 pages
File Size : 48,51 MB
Release : 2020-01-23
Category :
ISBN : 9781867313687
Have all basic functions of Good manufacturing practices been defined? For estimation problems, how do you develop an estimation statement? How do you monitor usage and cost? How will the Good manufacturing practices data be captured? What, related to, Good manufacturing practices processes does your organization outsource? This instant Good Manufacturing Practices self-assessment will make you the assured Good Manufacturing Practices domain master by revealing just what you need to know to be fluent and ready for any Good Manufacturing Practices challenge. How do I reduce the effort in the Good Manufacturing Practices work to be done to get problems solved? How can I ensure that plans of action include every Good Manufacturing Practices task and that every Good Manufacturing Practices outcome is in place? How will I save time investigating strategic and tactical options and ensuring Good Manufacturing Practices costs are low? How can I deliver tailored Good Manufacturing Practices advice instantly with structured going-forward plans? There's no better guide through these mind-expanding questions than acclaimed best-selling author Gerard Blokdyk. Blokdyk ensures all Good Manufacturing Practices essentials are covered, from every angle: the Good Manufacturing Practices self-assessment shows succinctly and clearly that what needs to be clarified to organize the required activities and processes so that Good Manufacturing Practices outcomes are achieved. Contains extensive criteria grounded in past and current successful projects and activities by experienced Good Manufacturing Practices practitioners. Their mastery, combined with the easy elegance of the self-assessment, provides its superior value to you in knowing how to ensure the outcome of any efforts in Good Manufacturing Practices are maximized with professional results. Your purchase includes access details to the Good Manufacturing Practices self-assessment dashboard download which gives you your dynamically prioritized projects-ready tool and shows you exactly what to do next. Your exclusive instant access details can be found in your book. You will receive the following contents with New and Updated specific criteria: - The latest quick edition of the book in PDF - The latest complete edition of the book in PDF, which criteria correspond to the criteria in... - The Self-Assessment Excel Dashboard - Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation - In-depth and specific Good Manufacturing Practices Checklists - Project management checklists and templates to assist with implementation INCLUDES LIFETIME SELF ASSESSMENT UPDATES Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.