Pharmaceutical Manufacturing Handbook, 2 Volume Set

SHAYNE COX GAD, PhD, DABT, ATS, is the Principal of Gad Consulting Services. Dr. Gad has more than thirty years of experience as a toxicologist, statistical consultant, manager, and general consultant on research and development in the chemical, consumer product, contract testing, biotechnology, medical device, and pharmaceutical industries. He is the author of twenty-nine books and numerous papers, presentations, and other publications.

• Pharmaceutical Manufacturing Handbook: Production and Processes PREFACE xiiiSECTION 1 MANUFACTURING SPECIALTIES 11.1 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. Arnold1.2 Regulatory Considerations in Approval on Follow-On Protein Drug Products 33Erin Oliver, Stephen M. Carl, Kenneth R. Morris, Gerald W. Becker, and Gregory T. Knipp1.3 Radiopharmaceutical Manufacturing 59Brit S. Farstad and Iván PeñuelasSECTION 2 ASEPTIC PROCESSING 972.1 Sterile Product Manufacturing 99James Agalloco and James AkersSECTION 3 FACILITY 1373.1 From Pilot Plant to Manufacturing: Effect of Scale-Up on Operation of Jacketed Reactors 139B. Wayne Bequette3.2 Packaging and Labeling 159Maria Inês Rocha Miritello Santoro and Anil Kumar Singh3.3 Clean-Facility Design, Construction, and Maintenance Issues 201Raymond K. SchneiderSECTION 4 NORMAL DOSAGE FORMS 2334.1 Solid Dosage Forms 235Barbara R. Conway4.2 Semisolid Dosages: Ointments, Creams, and Gels 267Ravichandran Mahalingam, Xiaoling Li, and Bhaskara R. Jasti4.3 Liquid Dosage Forms 313Maria V. Rubio-Bonilla, Roberto Londono, and Arcesio RubioSECTION 5 NEW DOSAGE FORMS 3455.1 Controlled-Release Dosage Forms 347Anil Kumar Anal5.2 Progress in the Design of Biodegradable Polymer-Based Microspheres for Parenteral Controlled Delivery of Therapeutic Peptide/Protein 393Shunmugaperumal Tamilvanan5.3 Liposomes and Drug Delivery 443Sophia G. Antimisiaris, Paraskevi Kallinteri, and Dimitrios G. Fatouros5.4 Biodegradable Nanoparticles 535Sudhir S. Chakravarthi and Dennis H. Robinson5.5 Recombinant Saccharomyces cerevisiae as New Drug Delivery System to Gut: In Vitro Validation and Oral Formulation 565Stéphanie Blanquet and Monique Alric5.6 Nasal Delivery of Peptide and Nonpeptide Drugs 591Chandan Thomas and Fakhrul Ahsan5.7 Nasal Powder Drug Delivery 651Jelena Filipovic Grcic and AnitaHafner5.8 Aerosol Drug Delivery 683Michael Hindle5.9 Ocular Drug Delivery 729Ilva D. Rupenthal and Raid G. Alany5.10 Microemulsions as Drug Delivery Systems 769Raid G. Alany and Jingyuan Wen5.11 Transdermal Drug Delivery 793C. Scott Asbill and Gary W. Bumgarner5.12 Vaginal Drug Delivery 809José das Neves, Maria Helena Amaral, and Maria Fernanda BahiaSECTION 6 TABLET PRODUCTION 8796.1 Pharmaceutical Preformulation: Physicochemical Properties of Excipients and Powers and Tablet Characterization 881Beom-Jin Lee6.2 Role of Preformulation in Development of Solid Dosage Forms 933Omathanu P. Perumal and Satheesh K. Podaralla6.3 Tablet Design 977Eddy Castellanos Gil, Isidoro Caraballo, and Bernard Bataille6.4 Tablet Production Systems 1053Katharina M. Picker-Freyer6.5 Controlled Release of Drugs from Tablet Coatings 1099Sacide Alsoy Altinkaya6.6 Tablet Compression 1133Helton M. M. Santos and Joao J. M. S. Sousa6.7 Effects of Grinding in Pharmaceutical Tablet Production 1165Gavin Andrews, David Jones, Hui Zhai, Osama Abu Diak, and Gavin Walker6.8 Oral Extended-Release Formulations 1191Anette Larsson, Susanna Abrahmsén-Alami, and Anne JuppoSECTION 7 ROLE OF NANOTECHNOLOGY 12237.1 Cyclodextrin-Based Nanomaterials in Pharmaceutical Field 1225Erem Bilensoy and A. Attila Hincal7.2 Nanotechnology in Pharmaceutical Manufacturing 1249Yiguang Jin7.3 Pharmaceutical Nanosystems: Manufacture, Characterization, and Safety 1289D. F. Chowdhury7.4 Oil-in-Water Nanosized Emulsions: Medical Applications 1327Shunmugaperumal TamilvananINDEX 1367Pharmaceutical Manufacturing Handbook: Regulations and QualityPREFACE xiiiSECTION 1 GOOD MANUFACTURING PRACTICES (GMP) AND OTHER FDA GUIDELINES 11.1 Good Manufacturing Practices (GMPs) and Related FDA Guidelines 3James R. Harris1.2 Enforcement of Current Good Manufacturing Practices 45Kenneth J. Nolan1.3 Scale-Up and Postapproval Changes (SUPAC) Regulations 67Puneet Sharma, Srinivas Ganta, and Sanjay Garg1.4 GMP-Compliant Propagation of Human Multipotent Mesenchymal Stromal Cells 97Eva Rohde, Katharina Schallmoser, Christina Bartmann, Andreas Reinisch, and Dirk StrunkSECTION 2 INTERNATIONAL REGULATIONS OF GOOD MANUFACTURING PRACTICES 1172.1 National GMP Regulations and Codes and International GMP Guides and Guildelines: Correspondences and Differences 119Marko Närhi and Katrina NordströmSECTION 3 QUALITY 1633.1 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 John3.2 Role of Quality Systems and Audits in Phatmaceutical Manufacturing Environment 201Evan B. Siegel and James M. Barquest3.3 Creating and Managing a Quality Management System 239Edward R. Arling, Michelle E. Dowling, and Paul A. Frankel3.4 Quality Process Improvement 287Jyh-hone WangSECTION 4 PROCESS ANALYTICAL TECHNOLOGY (PAT) 3114.1 Case for Process Analytical Technology: Regulatory and Industrial Perspectives 313Robert P. Cogdill4.2 Process Analytical Technology 353Michel Ulmschneider and Yves Roggo4.3 Chemical Imaging and Chemometrics: Useful Tools for Process Analytical Technology 411Yves Roggo and Michel UlmschneiderSECTION 5 PERSONNEL 4335.1 Personnel Training in Pharmaceutical Manufacturing 435David A. Gallup, Katherine V. Domenick, and Marge GillisSECTION 6 CONTAMINATION AND CONTAMINATION CONTROL 4556.1 Origin of Contamination 457Denise Bohrer6.2 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 Fox6.3 Microbiology of Nonsterile Pharmaceutical Manufacturing 543Ranga VelagaletiSECTION 7 DRUG STABILITY 5577.1 Stability and Shelf Life of Pharmaceutical Products 559Ranga Velagaleti7.2 Drug Stability 583Nazario D. Ramirez-Beltran, Harry Rodriguez, and L. Antonio Estévez7.3 Effect of Packaging on Stability of Drugs and Drug Products 641Emmanuel O. Akala7.4 Pharmaceutical Product Stability 687Andrew A. Webster7.5 Alternative Accelerated Methods for Studying Drug Stability: Variable-Parameter Kinetics 701Giuseppe AlibrandiSECTION 8 VALIDATION 7258.1 Analytical Method Validation: Principles and Practices 727Chung Chow Chan8.2 Analytical Method Validation and Quality Assurance 743Isabel Taverniers, Erik Van Bockstaele, and Marc De Loose8.3 Validation of Laboratory Instruments 791Herman Lam8.4 Pharmaceutical Manufacturing Validation Principles 811E. B. Souto T. Vasconcelos D. C. Ferreira, and B. SarmentoINDEX 839