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Pharmaceutical Manufacturing Handbook, 2 Volume Set. Pharmaceutical Development Series

  • ID: 2175392
  • Book
  • 2240 Pages
  • John Wiley and Sons Ltd
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Pharmaceutical Manufacturing Handbook covers a range of topics to help professionals better understand the methods used in the pharmaceutical manufacturing, pharmaceutical engineering, and process engineering fields. It covers many aspects, such as the building of a facility, to the various dosage and delivery forms available, and finally to the principles of validation. Other topics include quality assurance and regulatory requirements. Without exposure to all of these topics, professionals and others in the various pharmaceutical fields will not be able to produce quality drugs.
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Pharmaceutical Manufacturing Handbook: Production and Processes

PREFACE xiii

SECTION 1 MANUFACTURING SPECIALTIES 1

1.1 Biotechnology–Derived Drug Product Development 3Stephen M. Carl, David J. Lindley, Gregory T. Knipp, Kenneth R. Morris, Erin Oliver, Gerald W. Becker, and Robert D. Arnold

1.2 Regulatory Considerations in Approval on Follow–On Protein Drug Products 33Erin Oliver, Stephen M. Carl, Kenneth R. Morris, Gerald W. Becker, and Gregory T. Knipp

1.3 Radiopharmaceutical Manufacturing 59Brit S. Farstad and Iván Peñuelas

SECTION 2 ASEPTIC PROCESSING 97

2.1 Sterile Product Manufacturing 99James Agalloco and James Akers

SECTION 3 FACILITY 137

3.1 From Pilot Plant to Manufacturing: Effect of Scale–Up on Operation of Jacketed Reactors 139B. Wayne Bequette

3.2 Packaging and Labeling 159Maria Inês Rocha Miritello Santoro and Anil Kumar Singh

3.3 Clean–Facility Design, Construction, and Maintenance Issues 201Raymond K. Schneider

SECTION 4 NORMAL DOSAGE FORMS 233

4.1 Solid Dosage Forms 235Barbara R. Conway

4.2 Semisolid Dosages: Ointments, Creams, and Gels 267Ravichandran Mahalingam, Xiaoling Li, and Bhaskara R. Jasti

4.3 Liquid Dosage Forms 313Maria V. Rubio–Bonilla, Roberto Londono, and Arcesio Rubio

SECTION 5 NEW DOSAGE FORMS 345

5.1 Controlled–Release Dosage Forms 347Anil Kumar Anal

5.2 Progress in the Design of Biodegradable Polymer–Based Microspheres for Parenteral Controlled Delivery of Therapeutic Peptide/Protein 393Shunmugaperumal Tamilvanan

5.3 Liposomes and Drug Delivery 443Sophia G. Antimisiaris, Paraskevi Kallinteri, and Dimitrios G. Fatouros

5.4 Biodegradable Nanoparticles 535Sudhir S. Chakravarthi and Dennis H. Robinson

5.5 Recombinant Saccharomyces cerevisiae as New Drug Delivery System to Gut: In Vitro Validation and Oral Formulation 565Stéphanie Blanquet and Monique Alric

5.6 Nasal Delivery of Peptide and Nonpeptide Drugs 591Chandan Thomas and Fakhrul Ahsan

5.7 Nasal Powder Drug Delivery 651Jelena Filipovic Grcic and AnitaHafner

5.8 Aerosol Drug Delivery 683Michael Hindle

5.9 Ocular Drug Delivery 729Ilva D. Rupenthal and Raid G. Alany

5.10 Microemulsions as Drug Delivery Systems 769Raid G. Alany and Jingyuan Wen

5.11 Transdermal Drug Delivery 793C. Scott Asbill and Gary W. Bumgarner

5.12 Vaginal Drug Delivery 809José das Neves, Maria Helena Amaral, and Maria Fernanda Bahia

SECTION 6 TABLET PRODUCTION 879

6.1 Pharmaceutical Preformulation: Physicochemical Properties of Excipients and Powers and Tablet Characterization 881Beom–Jin Lee

6.2 Role of Preformulation in Development of Solid Dosage Forms 933Omathanu P. Perumal and Satheesh K. Podaralla

6.3 Tablet Design 977Eddy Castellanos Gil, Isidoro Caraballo, and Bernard Bataille

6.4 Tablet Production Systems 1053Katharina M. Picker–Freyer

6.5 Controlled Release of Drugs from Tablet Coatings 1099Sacide Alsoy Altinkaya

6.6 Tablet Compression 1133Helton M. M. Santos and Joao J. M. S. Sousa

6.7 Effects of Grinding in Pharmaceutical Tablet Production 1165Gavin Andrews, David Jones, Hui Zhai, Osama Abu Diak, and Gavin Walker

6.8 Oral Extended–Release Formulations 1191Anette Larsson, Susanna Abrahmsén–Alami, and Anne Juppo

SECTION 7 ROLE OF NANOTECHNOLOGY 1223

7.1 Cyclodextrin–Based Nanomaterials in Pharmaceutical Field 1225Erem Bilensoy and A. Attila Hincal

7.2 Nanotechnology in Pharmaceutical Manufacturing 1249Yiguang Jin

7.3 Pharmaceutical Nanosystems: Manufacture, Characterization, and Safety 1289D. F. Chowdhury

7.4 Oil–in–Water Nanosized Emulsions: Medical Applications 1327Shunmugaperumal Tamilvanan

INDEX 1367

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 3James R. Harris

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

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

1.4 GMP–Compliant Propagation of Human Multipotent Mesenchymal Stromal Cells 97Eva 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 119Marko 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 165Paul G. Ranky, Gregory N. Ranky, Richard G. Ranky, and Ashley John

3.2 Role of Quality Systems and Audits in Phatmaceutical Manufacturing Environment 201Evan B. Siegel and James M. Barquest

3.3 Creating and Managing a Quality Management System 239Edward R. Arling, Michelle E. Dowling, and Paul A. Frankel

3.4 Quality Process Improvement 287Jyh–hone Wang

SECTION 4 PROCESS ANALYTICAL TECHNOLOGY (PAT) 311

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

4.2 Process Analytical Technology 353Michel Ulmschneider and Yves Roggo

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

SECTION 5 PERSONNEL 433

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

SECTION 6 CONTAMINATION AND CONTAMINATION CONTROL 455

6.1 Origin of Contamination 457Denise 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 533Alvin Fox

6.3 Microbiology of Nonsterile Pharmaceutical Manufacturing 543Ranga Velagaleti

SECTION 7 DRUG STABILITY 557

7.1 Stability and Shelf Life of Pharmaceutical Products 559Ranga Velagaleti

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

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

7.4 Pharmaceutical Product Stability 687Andrew A. Webster

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

SECTION 8 VALIDATION 725

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

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

8.3 Validation of Laboratory Instruments 791Herman Lam

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

INDEX 839

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