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Sunday, June 28, 2015

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

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

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

Good Manufacturing Practices for Pharmaceuticals, Sixth Edition

Book cover Good Manufacturing Practices for Pharmaceuticals, Sixth Edition

Good Manufacturing Practices for Pharmaceuticals, Sixth Edition

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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
Download (pdf, 5.56 MB)

Good Design Practices for GMP Pharmaceutical Facilities

Book cover Good Design Practices for GMP Pharmaceutical Facilities

Good Design Practices for GMP Pharmaceutical Facilities

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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
Download (pdf, 18.08 MB)

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

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

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

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
Download (pdf, 404 KB)

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

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

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

Green Chemistry in the Pharmaceutical Industry

Book cover Green Chemistry in the Pharmaceutical Industry

Green Chemistry in the Pharmaceutical Industry

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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
Download (pdf, 6.63 MB)

Scalable Green Chemistry: Case Studies from the Pharmaceutical Industry

Book cover Scalable Green Chemistry: Case Studies from the Pharmaceutical Industry

Scalable Green Chemistry: Case Studies from the Pharmaceutical Industry

Year: 2013
Edition: 1
Language: English
Pages: 350

Practical Process Research and Development



Book cover Practical Process Research and Development

Practical Process Research and Development

Year: 2012
Edition: 2
Language: English
Pages: 472 

Tuesday, June 9, 2015

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

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

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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  
Year: 2004
Edition: 1
Language: English
Pages: 316

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



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

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

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Year: 2013
Edition: 1
Language: English
Pages: 359