Pharmaceutical Manufacturing Handbook: Regulations and Quality / Edition 1

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Overview

With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines.

The team of expert authors, all familiar with the many issues involved in compliance and quality control, offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing. The editor, who has 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.

Among the key topics covered are: Enforcement of current good manufacturing practices, Inspections by health regulatory agencies, Creating and managing a quality management system, Personnel training within pharmaceutical manufacturing, Microbiology of non-sterile pharmaceutical manufacturing, Pharmaceutical manufacturing validation principles.

Following the handbook's carefully developed guidelines and advice helps you ensure your company's full compliance and avoid potential costly pitfalls. This publication should be readily accessible to all scientists, engineers, and managers involved in pharmaceutical manufacturing.

About the Author:
Shayne Cox GAD, PhD, DABT, ATS, is the Principal of Gad Consulting Services

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Editorial Reviews

From the Publisher
This book is a valuable reference … .The book contains everything you need to ensure full compliance and superior quality control. (Pharmaceutical Technology Magazine, July 2, 2008)
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Product Details

  • ISBN-13: 9780470259597
  • Publisher: Wiley
  • Publication date: 3/28/2008
  • Series: Pharmaceutical Development Series , #6
  • Edition number: 1
  • Pages: 856
  • Product dimensions: 7.30 (w) x 10.08 (h) x 1.63 (d)

Meet the Author

SHAYNE COX GAD, PhD, DABT, ATS, is the Principal of Gad Consulting Services. Dr. Gad has more than thirty years of experience as a toxicologist, statistical consultant, manager, and general consultant on research and development in the chemical, consumer product, contract testing, biotechnology, medical device, and pharmaceutical industries. He is the author of twenty-nine books and numerous papers, presentations, and other publications.
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Table of Contents


Preface     xiii
Good Manufacturing Practices (GMP) and Other FDA Guidelines     1
Good Manufacturing Practices (GMPs) and Related FDA Guidelines   James R. Harris     3
Enforcement of Current Good Manufacturing Practices   Kenneth J. Nolan     45
Scale-Up and Postapproval Changes (SUPAC) Regulations   Puneet Sharma   Srinivas Ganta   Sanjay Garg     67
GMP-Compliant Propagation of Human Multipotent Mesenchymal Stromal Cells   Eva Rohde   Katharina Schallmoser   Christina Bartmann   Andreas Reinisch   Dirk Strunk     97
International Regulations of Good Manufacturing Practices     117
National GMP Regulations and Codes and International GMP Guides and Guildelines: Correspondences and Differences   Marko Narhi   Katrina Nordstrom     119
Quality     163
Analytical and Computational Methods and Examples for Designing and Controlling Total Quality Management Pharmaceutical Manufacturing Systems   Paul G. Ranky   Gregory N. Ranky   Richard G. Ranky   Ashley John     165
Role of Quality Systems and Audits in Phatmaceutical Manufacturing Environment   Evan B. Siegel   James M. Barquest     201
Creating and Managing a QualityManagement System   Edward R. Arling   Michelle E. Dowling   Paul A. Frankel     239
Quality Process Improvement   Jyh-hone Wang     287
Process Analytical Technology (PAT)     311
Case for Process Analytical Technology: Regulatory and Industrial Perspectives   Robert P. Cogdill     313
Process Analytical Technology   Michel Ulmschneider   Yves Roggo     353
Chemical Imaging and Chemometrics: Useful Tools for Process Analytical Technology   Yves Roggo   Michel Ulmschneider     411
Personnel     433
Personnel Training in Pharmaceutical Manufacturing   David A. Gallup   Katherine V. Domenick   Marge Gillis     435
Contamination and Contamination Control     455
Origin of Contamination   Denise Bohrer     457
Quantitation of Markers for Gram-Negative and Gram-Positive Endotoxins in Work Environment and as Contaminants in Pharmaceutical Products Using Gas Chromatography-Tandem Mass Spectrometry   Alvin Fox     533
Microbiology of Nonsterile Pharmaceutical Manufacturing   Ranga Velagaleti     543
Drug Stability     557
Stability and Shelf Life of Pharmaceutical Products   Ranga Velagaleti      559
Drug Stability   Nazario D. Ramirez-Beltran   Harry Rodriguez   L. Antonio Estevez     583
Effect of Packaging on Stability of Drugs and Drug Products   Emmanuel O. Akala     641
Pharmaceutical Product Stability   Andrew A. Webster     687
Alternative Accelerated Methods for Studying Drug Stability: Variable-Parameter Kinetics   Giuseppe Alibrandi     701
Validation     725
Analytical Method Validation: Principles and Practices   Chung Chow Chan     727
Analytical Method Validation and Quality Assurance   Isabel Taverniers   Erik Van Bockstaele   Marc De Loose     743
Validation of Laboratory Instruments   Herman Lam     791
Pharmaceutical Manufacturing Validation Principles   E. B. Souto   T. Vasconcelos   D. C. Ferreira   B. Sarmento     811
Index     839
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