Pharmaceutical Manufacturing Handbook
Regulations and Quality
Pharmaceutical Development (Series Nr. 2)
1. Edition April 2008
856 Pages, Hardcover
Wiley & Sons Ltd
Short Description
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.
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.
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.
