04773oam 2200685Ia 450 991078500060332120231102195920.01-281-23752-397866112375230-470-25983-30-470-25982-5(CKB)1000000000407538(EBL)333795(OCoLC)214281909(SSID)ssj0000220589(PQKBManifestationID)11196551(PQKBTitleCode)TC0000220589(PQKBWorkID)10143453(PQKB)11588649(MiAaPQ)EBC333795(Au-PeEL)EBL333795(CaPaEBR)ebr10226806(CaONFJC)MIL123752(PPN)243348118(EXLCZ)99100000000040753820080128h20082008 uy 0engur|n|---|||||txtrdacontentcrdamediacrrdacarrierPharmaceutical manufacturing handbook regulations and quality /[edited by] Shayne Cox GadHoboken, N.J. :Wiley-Interscience,2008.©20081 online resource (857 pages)Pharmaceutical Development Series0-470-25959-0 Includes bibliographical references and index.PHARMACEUTICAL MANUFACTURING HANDBOOK Regulations and Quality; CONTRIBUTORS; CONTENTS; PREFACE; SECTION 1 GOOD MANUFACTURING PRACTICES (GMP) AND OTHER FDA GUIDELINES; 1.1 Good Manufacturing Practices (GMPs) and Related FDA Guidelines; 1.2 Enforcement of Current Good Manufacturing Practices; 1.3 Scale-Up and Postapproval Changes (SUPAC) Regulations; 1.4 GMP-Compliant Propagation of Human Multipotent Mesenchymal Stromal Cells; SECTION 2 INTERNATIONAL REGULATIONS OF GOOD MANUFACTURING PRACTICES2.1 National GMP Regulations and Codes and International GMP Guides and Guildelines: Correspondences and Differences; SECTION 3 QUALITY; 3.1 Analytical and Computational Methods and Examples for Designing and Controlling Total Quality Management Pharmaceutical Manufacturing Systems; 3.2 Role of Quality Systems and Audits in Phatmaceutical Manufacturing Environment; 3.3 Creating and Managing a Quality Management System; 3.4 Quality Process Improvement; SECTION 4 PROCESS ANALYTICAL TECHNOLOGY (PAT); 4.1 Case for Process Analytical Technology: Regulatory and Industrial Perspectives4.2 Process Analytical Technology; 4.3 Chemical Imaging and Chemometrics: Useful Tools for Process Analytical Technology; SECTION 5 PERSONNEL; 5.1 Personnel Training in Pharmaceutical Manufacturing; SECTION 6 CONTAMINATION AND CONTAMINATION CONTROL; 6.1 Origin of Contamination; 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; 6.3 Microbiology of Nonsterile Pharmaceutical Manufacturing; SECTION 7 DRUG STABILITY7.1 Stability and Shelf Life of Pharmaceutical Products; 7.2 Drug Stability; 7.3 Effect of Packaging on Stability of Drugs and Drug Products; 7.4 Pharmaceutical Product Stability; 7.5 Alternative Accelerated Methods for Studying Drug Stability: Variable-Parameter Kinetics; SECTION 8 VALIDATION; 8.1 Analytical Method Validation: Principles and Practices; 8.2 Analytical Method Validation and Quality Assurance; 8.3 Validation of Laboratory Instruments; 8.4 Pharmaceutical Manufacturing Validation Principles; INDEXWith 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.Pharmaceutical Development Series;6Pharmaceutical technologyQuality controlHandbooks, manuals, etcPharmacyLaw and legislationUnited StatesHandbooks, manuals, etcDrugsLaw and legislationUnited StatesHandbooks, manuals, etcPharmaceutical technologyQuality controlPharmacyLaw and legislationDrugsLaw and legislation615.19615/.19Gad Shayne C.1948-96171MiAaPQMiAaPQMiAaPQBOOK9910785000603321Pharmaceutical manufacturing handbook3781596UNINA