Pharmaceutical Manufacturing Handbook, 2 Volume Set

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.

Pharmaceutical Manufacturing Handbook: Production and Processes PREFACE xiii SECTION 1 MANUFACTURING SPECIALTIES 1 1.1 Biotechnology-Derived Drug Product Development 3 Stephen 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 33 Erin Oliver, Stephen M. Carl, Kenneth R. Morris, Gerald W. Becker, and Gregory T. Knipp 1.3 Radiopharmaceutical Manufacturing 59 Brit S. Farstad and Iván Peñuelas SECTION 2 ASEPTIC PROCESSING 97 2.1 Sterile Product Manufacturing 99 James Agalloco and James Akers SECTION 3 FACILITY 137 3.1 From Pilot Plant to Manufacturing: Effect of Scale-Up on Operation of Jacketed Reactors 139 B. Wayne Bequette 3.2 Packaging and Labeling 159 Maria Inês Rocha Miritello Santoro and Anil Kumar Singh 3.3 Clean-Facility Design, Construction, and Maintenance Issues 201 Raymond K. Schneider SECTION 4 NORMAL DOSAGE FORMS 233 4.1 Solid Dosage Forms 235 Barbara R. Conway 4.2 Semisolid Dosages: Ointments, Creams, and Gels 267 Ravichandran Mahalingam, Xiaoling Li, and Bhaskara R. Jasti 4.3 Liquid Dosage Forms 313 Maria V. Rubio-Bonilla, Roberto Londono, and Arcesio Rubio SECTION 5 NEW DOSAGE FORMS 345 5.1 Controlled-Release Dosage Forms 347 Anil Kumar Anal 5.2 Progress in the Design of Biodegradable Polymer-Based Microspheres for Parenteral Controlled Delivery of Therapeutic Peptide/Protein 393 Shunmugaperumal Tamilvanan 5.3 Liposomes and Drug Delivery 443 Sophia G. Antimisiaris, Paraskevi Kallinteri, and Dimitrios G. Fatouros 5.4 Biodegradable Nanoparticles 535 Sudhir S. Chakravarthi and Dennis H. Robinson 5.5 Recombinant Saccharomyces cerevisiae as New Drug Delivery System to Gut: In Vitro Validation and Oral Formulation 565 Stéphanie Blanquet and Monique Alric 5.6 Nasal Delivery of Peptide and Nonpeptide Drugs 591 Chandan Thomas and Fakhrul Ahsan 5.7 Nasal Powder Drug Delivery 651 Jelena Filipovic Grcic and AnitaHafner 5.8 Aerosol Drug Delivery 683 Michael Hindle 5.9 Ocular Drug Delivery 729 Ilva D. Rupenthal and Raid G. Alany 5.10 Microemulsions as Drug Delivery Systems 769 Raid G. Alany and Jingyuan Wen 5.11 Transdermal Drug Delivery 793 C. Scott Asbill and Gary W. Bumgarner 5.12 Vaginal Drug Delivery 809 José 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 881 Beom-Jin Lee 6.2 Role of Preformulation in Development of Solid Dosage Forms 933 Omathanu P. Perumal and Satheesh K. Podaralla 6.3 Tablet Design 977 Eddy Castellanos Gil, Isidoro Caraballo, and Bernard Bataille 6.4 Tablet Production Systems 1053 Katharina M. Picker-Freyer 6.5 Controlled Release of Drugs from Tablet Coatings 1099 Sacide Alsoy Altinkaya 6.6 Tablet Compression 1133 Helton M. M. Santos and Joao J. M. S. Sousa 6.7 Effects of Grinding in Pharmaceutical Tablet Production 1165 Gavin Andrews, David Jones, Hui Zhai, Osama Abu Diak, and Gavin Walker 6.8 Oral Extended-Release Formulations 1191 Anette Larsson, Susanna Abrahmsén-Alami, and Anne Juppo SECTION 7 ROLE OF NANOTECHNOLOGY 1223 7.1 Cyclodextrin-Based Nanomaterials in Pharmaceutical Field 1225 Erem Bilensoy and A. Attila Hincal 7.2 Nanotechnology in Pharmaceutical Manufacturing 1249 Yiguang Jin 7.3 Pharmaceutical Nanosystems: Manufacture, Characterization, and Safety 1289 D. F. Chowdhury 7.4 Oil-in-Water Nanosized Emulsions: Medical Applications 1327 Shunmugaperumal 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 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