Pharmaceutical Manufacturing Handbook : Regulations and Quality

by Editor: Shayne Cox Gad (IBS, Raleigh, North Carolina)

• ISBN13: 9780470259825
• ISBN10: 0470259825
• Format: eBook
• Copyright: 2008-04-01
• Publisher: Wiley-Interscience

Summary

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

Contributors

Preface

GOOD MANUFACTURING PRACTICES (GMP) AND OTHER FDA GUIDELINES.

Good Manufacturing Practices (GMPs) and Related FDA Guidelines

Enforcement of Current Good Manufacturing Practices (Kenneth J. Nolan

Scale-Up and Postapproal Changes (SUPAC) Regulations

GMP-Compliant Propagation of Human Multipotent Mesenchymal Stromal Cells

INTERNATIONAL REGULATIONS OF GOOD MANUFACTURING PRACTICES.

National GMP Regulations and Codes and international GMP Guides and Guildelines: Correspondences and Differences

SECTION 3 QUALITY.

Analytical and Computational Methods and Examples for Designing and Controlling total Quality Management Pharmaceutical Manufacturing systems

Role of Quality Systems and Audits in Phatmaceutical Manufacturing Environment

Creating and Managing a Quality Management system

Quality process improement (Jyh-hone Wang).

SECTION 4 PROCESS ANALYTICAL TECHNOLOGY (PAT).

Case for Process Analytical Technology: Regulatory and Industrial Perspectives

Process Analytical Technology

Chemical imaging and Chemometrics: Useful Tools for Process Analytical Technology

SECTION 5 PERSONNEL.

Personnel Training in Pharmaceutical Manufacturing

CONTAMINATION AND CONTAMINATION CONTROL.

Origin of Contamination

Quantitation of Markers for Gram-Negatie and Gram-Positive Endotoxins in Work Enironment and as Contaminants in Pharmaceutical Products Using Gas ChromatographyûTandem Mass Spectrometry

Microbiology of Nonsterile Pharmaceutical Manufacturing

SECTION 7 DRUG STABILITY.

Stability and Shelf Life of Pharmaceutical Products

Drug Stability

Effect of Packaging on Stability of Drugs and Drug Products

Pharmaceutical Product Stability

Alternative Accelerated Methods for Studying Drug Stability: Variable-Parameter Kinetics

SECTION 8 VALIDATION.

Analytical Method Validation: Principles and Practices

Method Validation and Quality Assurance

Validation of Laboratory Instruments

Pharmaceutical Manufacturing Validation Principles

Index.

Table of Contents provided by Publisher. All Rights Reserved.