Pharmaceutical manufacturing handbook : regulations and quality / edited by Shayne Cox Gad.

Contents;

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 Postapproval 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 201
Evan B. Siegel and James M. Barquest

3.3 Creating and Managing a Quality Management System 239
Edward R. Arling, Michelle E. Dowling, and Paul A. Frankel
3.4 Quality Process Improvement
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 and 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-Negative and Gram-Positive Endotoxins in Work Environment and as Contaminants in Pharmaceutical Products Using Gas Chromatography–Tandem Mass Spectrometry
Alvin Fox
6.3 Microbiology of Nonsterile Pharmaceutical Manufacturing 5
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
Emmanuel 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 Analytical 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

Includes bibliographical references and index.