Pharmaceutical Manufacturing Handbook

Regulations and Quality
Herausgegeben:Gad, Shayne Cox

• Gebundenes Buch

Produktbeschreibung

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:
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Enforcement of current good manufacturing practices
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Inspections by health regulatory agencies
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Creating and managing a quality management system
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Personnel training within pharmaceutical manufacturing
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Microbiology of non-sterile pharmaceutical manufacturing
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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.

Produktdetails

• Pharmaceutical Development 2
• Verlag: Wiley & Sons
• 1. Auflage
• Seitenzahl: 856
• Erscheinungstermin: 1. März 2008
• Englisch
• Abmessung: 253mm x 186mm x 45mm
• Gewicht: 1560g
• ISBN-13: 9780470259597
• ISBN-10: 0470259590
• Artikelnr.: 23161509

Autorenporträt

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.

Inhaltsangabe

CONTRIBUTORS. PREFACE. SECTION 1 GOOD MANUFACTURING PRACTICES (GMP) AND
OTHER FDA GUIDELINES. 1.1 Good Manufacturing Practices (GMPs) and Related
FDA Guidelines (James R. Harris). 1.2 Enforcement of Current Good
Manufacturing Practices (Kenneth J. Nolan). 1.3 Scale-Up and Postapproal
Changes (SUPAC) Regulations (Puneet Sharma, Srinivas Ganta, and Sanjay
Garg). 1.4 GMP-Compliant Propagation of Human Multipotent Mesenchymal
Stromal Cells (Eva Rohde, Katharina Schallmoser, Christina Bartmann,
Andreas Reinisch, and Dirk Strunk). SECTION 2 INTERNATIONAL REGULATIONS OF
GOOD MANUFACTURING PRACTICES. 2.1 National GMP Regulations and Codes and
international GMP Guides and Guildelines: Correspondences and Differences
(Marko Närhi and Katrina Nordström). SECTION 3 QUALITY. 3.1 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, and Ashley John). 3.2 Role of Quality
Systems and Audits in Phatmaceutical Manufacturing Environment (Evan B.
Siegel and James M. Barquest). 3.3 Creating and Managing a Quality
Management system (Edward R. Arling, Michelle E. Dowling, and Paul A.
Frankel). 3.4 Quality process improement (Jyh-hone Wang). SECTION 4 PROCESS
ANALYTICAL TECHNOLOGY (PAT). 4.1 Case for Process Analytical Technology:
Regulatory and Industrial Perspectives (Robert P. Cogdill). 4.2 Process
Analytical Technology (Michel Ulmschneider, Yves Roggo). 4.3 Chemical
imaging and Chemometrics: Useful Tools for Process Analytical Technology
(Yves Roggo and Michel Ulmschneider). SECTION 5 PERSONNEL. 5.1 Personnel
Training in Pharmaceutical Manufacturing (David A. Gallup, Katherine V.
Domenick, and Marge Gillis). SECTION 6 CONTAMINATION AND CONTAMINATION
CONTROL. 6.1 Origin of Contamination (Denise Bohrer). 6.2 Quantitation of
Markers for Gram-Negatie and Gram-Positive Endotoxins in Work Enironment
and as Contaminants in Pharmaceutical Products Using Gas
Chromatography-Tandem Mass Spectrometry (Alvin Fox). 6.3 Microbiology of
Nonsterile Pharmaceutical Manufacturing (Ranga Velagaleti). SECTION 7 DRUG
STABILITY. 7.1 Stability and Shelf Life of Pharmaceutical Products (Ranga
Velagaleti). 7.2 Drug Stability (Nazario D. Ramirez-Beltran, Harry
Rodriguez, and L. Antonio Estévez). 7.3 Effect of Packaging on Stability of
Drugs and Drug Products (Emmanvel O. Akala). 7.4 Pharmaceutical Product
Stability (Andrew A. Webster). 7.5 Alternative Accelerated Methods for
Studying Drug Stability: Variable-Parameter Kinetics (Giuseppe Alibrandi).
SECTION 8 VALIDATION. 8.1 Analytical Method Validation: Principles and
Practices (Chung Chow Chan). 8.2 Method Validation and Quality Assurance
(Isabel Taverniers, Erik Van Bockstaele, and Marc De Loose). 8.3 Validation
of Laboratory Instruments (Herman Lam). 8.4 Pharmaceutical Manufacturing
Validation Principles (E. B. Souto T. Vasconcelos D. C. Ferreira, and B.
Sarmento). Index.

Rezensionen

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)