Catalogue


Pharmaceutical manufacturing handbook : regulations and quality /
[edited by] Shayne Cox Gad.
imprint
Hoboken, N.J. : John Wiley & Sons, c2008.
description
xiii, 841 p. : ill.
ISBN
9780470259597 (cloth)
format(s)
Book
Holdings
More Details
added author
imprint
Hoboken, N.J. : John Wiley & Sons, c2008.
isbn
9780470259597 (cloth)
catalogue key
7020735
 
Includes bibliographical references and index.
A Look Inside
About the Author
Author Affiliation
Shayne Cox GAD, PhD, DABT, ATS, is the Principal of Gad Consulting Services
Reviews
Review Quotes
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)
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)
This item was reviewed in:
SciTech Book News, June 2008
To find out how to look for other reviews, please see our guides to finding book reviews in the Sciences or Social Sciences and Humanities.
Summaries
Back Cover Copy
Everything you need to ensure full compliance and superior quality control 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 yearsa? 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 handbooka's carefully developed guidelines and advice helps you ensure your companya's full compliance and avoid potential costly pitfalls. This publication should be readily accessible to all scientists, engineers, and managers involved in pharmaceutical manufacturing.
Back Cover Copy
Everything you need to ensure full compliance and superior quality controlWith 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 yearsa? 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 handbooka's carefully developed guidelines and advice helps you ensure your companya's full compliance and avoid potential costly pitfalls. This publication should be readily accessible to all scientists, engineers, and managers involved in pharmaceutical manufacturing.
Back Cover Copy
Everything you need to ensure full compliance and superior quality control 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.
Long Description
Everything you need to ensure full compliance and superior quality control 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.
Long Description
Everything you need to ensure full compliance and superior quality control 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 handbooks carefully developed guidelines and advice helps you ensure your companys full compliance and avoid potential costly pitfalls. This publication should be readily accessible to all scientists, engineers, and managers involved in pharmaceutical manufacturing.
Main Description
Everything you need to ensure full compliance and superior quality controlWith 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.
Main Description
Everything you need to ensure full compliance and superior quality control 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.
Main Description
This handbook describes the regulatations and quality control issues that are key to pharmaceutical manufacturing. Covering details like the FDA in the US, intrernational regulation, good manufacturing practice (GMP), and process analytical technology (PAT); the book thoroughly exposes professional manufacturers and engineers to the key issues they need to understand in order to properly do their jobs. In addition, the book covers quality assurance and validation, drug stability, and contamination control -- aspects that are heavily influenced by regulatory guidelines.
Main Description
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.
Main Description
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 offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.
Table of Contents
Prefacep. xiii
Good Manufacturing Practices (GMP) and Other FDA Guidelinesp. 1
Good Manufacturing Practices (GMPs) and Related FDA Guidelinesp. 3
Enforcement of Current Good Manufacturing Practicesp. 45
Scale-Up and Postapproval Changes (SUPAC) Regulationsp. 67
GMP-Compliant Propagation of Human Multipotent Mesenchymal Stromal Cellsp. 97
International Regulations of Good Manufacturing Practicesp. 117
National GMP Regulations and Codes and International GMP Guides and Guildelines: Correspondences and Differencesp. 119
Qualityp. 163
Analytical and Computational Methods and Examples for Designing and Controlling Total Quality Management Pharmaceutical Manufacturing Systemsp. 165
Role of Quality Systems and Audits in Phatmaceutical Manufacturing Environmentp. 201
Creating and Managing a Quality Management Systemp. 239
Quality Process Improvementp. 287
Process Analytical Technology (PAT)p. 311
Case for Process Analytical Technology: Regulatory and Industrial Perspectivesp. 313
Process Analytical Technologyp. 353
Chemical Imaging and Chemometrics: Useful Tools for Process Analytical Technologyp. 411
Personnelp. 433
Personnel Training in Pharmaceutical Manufacturingp. 435
Contamination and Contamination Controlp. 455
Origin of Contaminationp. 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 Spectrometryp. 533
Microbiology of Nonsterile Pharmaceutical Manufacturingp. 543
Drug Stabilityp. 557
Stability and Shelf Life of Pharmaceutical Productsp. 559
Drug Stabilityp. 583
Effect of Packaging on Stability of Drugs and Drug Productsp. 641
Pharmaceutical Product Stabilityp. 687
Alternative Accelerated Methods for Studying Drug Stability: Variable-Parameter Kineticsp. 701
Validationp. 725
Analytical Method Validation: Principles and Practicesp. 727
Analytical Method Validation and Quality Assurancep. 743
Validation of Laboratory Instrumentsp. 791
Pharmaceutical Manufacturing Validation Principlesp. 811
Indexp. 839
Table of Contents provided by Ingram. All Rights Reserved.

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