Good Manufacturing Practices for Pharmaceuticals: A Plan for Total Quality from Manufacturer to Consumer

Willig S. H.

The book contains black-and-white illustrations.This book examines U.S. law and governmental policy affecting domestic and multinational pharmaceutical manufacturing, recommending pragmatic ways to interpret and comply with FDA current good manufacturing practice (CGMP) regulation and related criteria.

Year: 2001

Edition: 1st edition

Language: English

Pages: 732

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Good Manufacturing Practices for Pharmaceuticals, Sixth Edition

Graham Bunn, Joseph D. Nally

With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.

Year: 2006

Edition: 6

Language: English

Pages: 418

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Good Design Practices for GMP Pharmaceutical Facilities

Andrew Signore, Terry Jacobs

A convenient single-source reference for anyone involved in the planning, construction, validation, and maintenance of modern pharmaceutical facilities, this guide assists project managers as they develop, diagram, and implement pharmaceutical production facility projects-demonstrating how advances in technology and external regulation can impact the production and efficacy of a pharmaceutical facility and the products it produces.

Year: 2005

Edition: 1

Language: English

Pages: 578

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Compact Regs Parts 210 and 211: CFR 21 Parts 210 and 211 Pharmaceutical and Bulk Chemical

Compact Regs Parts 210 and 211: CFR 21 Parts 210 and 211 Pharmaceutical and Bulk Chemical GMPs

Food and Drug Administration

The Compact Regs series provides full-text, pocket-sized format (3 3/4 inch x 5 1/2 inch) verbatim reproductions of key US FDA regulations. The texts are complete and have not been altered in any manner from the original sources. They are the perfect low-cost tools for: employees as part of documented GMP training programs, for suppliers/vendors so that they may provide components, labels, and parts with an understanding of FDA requirements, and for each clinical investigator, nurse, and technician to help assure compliance to clinical trial protocols. A keyword index can be found at the end of each booklet.

Year: 2002

Edition: 1

Language: English

Pages: 106

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21 CFR 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

Orlando Lopez

This guide delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with FDA regulations related to international computer validation in the pharmaceutical industry. The guide shows how to comply with computer systems validation requirements, while highlighting and integrating Part 11 requirements into the entire computer validation program. Regulatory compliance is placed within the context of quality assurance, and the importance of integrating validation into the system life cycle using a structured top-down approach is stressed. Information is applicable to computer systems for pharmaceuticals, cosmetics, food, and medical device applications.

Year: 2004

Edition: 1

Language: English

Pages: 287

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Green Chemistry in the Pharmaceutical Industry

Peter Dunn, Andrew Wells, Michael T. Williams

Edited by three of the world's leading pharmaceutical scientists, this is the first book on this important and hot topic, containing much previously unpublished information. As such, it covers all aspects of green chemistry in the pharmaceutical industry, from simple molecules to complex proteins, and from drug discovery to the fate of pharmaceuticals in the environment. Furthermore, this ready reference contains several convincing case studies from industry, such as Taxol, Pregabalin and Crestor, illustrating how this multidisciplinary approach has yielded efficient and environmentally-friendly processes. Finally, a section on technology and tools highlights the advantages of green chemistry.

Year: 2010

Edition: 1

Language: English

Pages: 388

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Scalable Green Chemistry: Case Studies from the Pharmaceutical Industry

Stefan Koenig

Year: 2013

Edition: 1

Language: English

Pages: 350

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Practical Process Research and Development

Neal G. Anderson (Auth.)

Year: 2012

Edition: 2

Language: English

Pages: 472 

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John Wiley And Sons Analytical Method Validation And Instrument Calibration -Ddu

Tze-Fun Chan, Y. C. Lee, Herman Lam, Xue-Ming Zhang

Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.  

Year: 2004

Edition: 1

Language: English

Pages: 316

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Specification of Drug Substances and Products. Development and Validation of Analytical Methods

Christopher M. Riley, Thomas W. Rosanske and Shelley R. Rabel Riley (Auth.)

Year: 2013

Edition: 1

Language: English

Pages: 359

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