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The FDA & Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals, (With CD-ROM)

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Title: The FDA & Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals, (With CD-ROM)
Author: Jose Rodriguez-Perez
ISBN: 8174890424 / 9788174890429
Format: Hard Cover + CD Rom
Pages: 396
Publisher: ASQ/Infotech
Year: 2016
Availability: In Stock
Special Indian Edition Priced at Rs.1595/-. FREE Shipping within India. Delivery : Within 2 to 4 working days.
     
 
  • Description
  • Contents

Good Manufacturing Practices (GMP) for human pharmaceuticals affects every patient taking a medicine. GMP covers all aspects of the manufacturing process, from defining manufacturing processes to systems for recall and investigation of complaints. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective.

GMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.

This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS.

A companion CD contains dozens of FDA guidance documents as well as international harmonization documents (WHO, PIC/S, and ICH). A check list for cGMP audit is also included based on risk management criteria. An exam complements the material included in the CD.

List of Figures and Tables
Preface
List of Acronyms

Chapter 1 : Introduction
Chapter 2 : US Current Good Manufacturing Practice
Chapter 3 : International Good Manufacturing Practice
Chapter 4 : Global Good Manufacturing Practice Guides and Harmonization
Chapter 5 : Detailed Analysis of the Requirements and Guidances
Chapter 6 : Missing Subparts
Chapter 7 : What are Inspectors Looking For?
Chapter 8 : Quality at Risk : The Price of Noncompliance

Appendix : At-a-Glance Comparisons
Bibliography
Useful Websites
Index

 
 
 
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