Pharmaceutical Manufacturing Handbook: Regulations and Quality - Couverture rigide

Couverture rigide

ISBN 10 : 0470259590 ISBN 13 : 9780470259597

Editeur : Wiley–Blackwell, 2008

Synopsis

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A propos du livre

Quatrième de couverture :

Everything you need to ensure full compliance and superiorquality control

With its coverage of Food and Drug Administration regulations,international regulations, good manufacturing practices, andprocess analytical technology, this handbook offers completecoverage of the regulations and quality control issues that governpharmaceutical manufacturing. In addition, the book discussesquality assurance and validation, drug stability, and contaminationcontrol, all key aspects of pharmaceutical manufacturing that areheavily influenced by regulatory guidelines.

The team of expert authors, all familiar with the many issuesinvolved in compliance and quality control, offer you advice basedon their own firsthand experience in all phases of pharmaceuticalmanufacturing. 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 isthorough, 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 andadvice helps you ensure your company′s full compliance and avoidpotential costly pitfalls. This publication should be readilyaccessible to all scientists, engineers, and managers involved inpharmaceutical manufacturing.

Présentation de l'éditeur :

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.

À propos de cette édition

• Éditeur: Wiley–Blackwell
• Date d'édition: 2008
• ISBN 10: 0470259590
• ISBN 13: 9780470259597
• Reliure: Relié
• Nombre de pages: 856