Pharmaceutical Manufacturing Handbook: Regulations and Quality

PREFACE xiii

SECTION 1 GOOD MANUFACTURING PRACTICES (GMP) AND OTHER FDA GUIDELINES 1

1.1 Good Manufacturing Practices (GMPs) and Related FDA Guidelines 3
James R. Harris

1.2 Enforcement of Current Good Manufacturing Practices 45
Kenneth J. Nolan

1.3 Scale-Up and Postapproval Changes (SUPAC) Regulations 67
Puneet Sharma, Srinivas Ganta, and Sanjay Garg

1.4 GMP-Compliant Propagation of Human Multipotent Mesenchymal Stromal Cells 97
Eva Rohde, Katharina Schallmoser, Christina Bartmann, Andreas Reinisch, and Dirk Strunk

SECTION 2 INTERNATIONAL REGULATIONS OF GOOD MANUFACTURING PRACTICES 117

2.1 National GMP Regulations and Codes and International GMP Guides and Guildelines: Correspondences and Differences 119
Marko Närhi and Katrina Nordström

SECTION 3 QUALITY 163

3.1 Analytical and Computational Methods and Examples for Designing and Controlling Total Quality Management Pharmaceutical Manufacturing Systems 165
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 287
Jyh-hone Wang

SECTION 4 PROCESS ANALYTICAL TECHNOLOGY (PAT) 311

4.1 Case for Process Analytical Technology: Regulatory and Industrial Perspectives 313
Robert P. Cogdill

4.2 Process Analytical Technology 353
Michel Ulmschneider and Yves Roggo

4.3 Chemical Imaging and Chemometrics: Useful Tools for Process Analytical Technology 411
Yves Roggo and Michel Ulmschneider

SECTION 5 PERSONNEL 433

5.1 Personnel Training in Pharmaceutical Manufacturing 435
David A. Gallup, Katherine V. Domenick, and Marge Gillis

SECTION 6 CONTAMINATION AND CONTAMINATION CONTROL 455

6.1 Origin of Contamination 457
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 533
Alvin Fox

6.3 Microbiology of Nonsterile Pharmaceutical Manufacturing 543
Ranga Velagaleti

SECTION 7 DRUG STABILITY 557

7.1 Stability and Shelf Life of Pharmaceutical Products 559
Ranga Velagaleti

7.2 Drug Stability 583
Nazario D. Ramirez-Beltran, Harry Rodriguez, and L. Antonio Estévez

7.3 Effect of Packaging on Stability of Drugs and Drug Products 641
Emmanuel O. Akala

7.4 Pharmaceutical Product Stability 687
Andrew A. Webster

7.5 Alternative Accelerated Methods for Studying Drug Stability: Variable-Parameter Kinetics 701
Giuseppe Alibrandi

SECTION 8 VALIDATION 725

8.1 Analytical Method Validation: Principles and Practices 727
Chung Chow Chan

8.2 Analytical Method Validation and Quality Assurance 743
Isabel Taverniers, Erik Van Bockstaele, and Marc De Loose

8.3 Validation of Laboratory Instruments 791
Herman Lam

8.4 Pharmaceutical Manufacturing Validation Principles 811
E. B. Souto T. Vasconcelos D. C. Ferreira, and B. Sarmento

INDEX 839