LEADER 04773oam 2200685Ia 450 001 9910785000603321 005 20231102195920.0 010 $a1-281-23752-3 010 $a9786611237523 010 $a0-470-25983-3 010 $a0-470-25982-5 035 $a(CKB)1000000000407538 035 $a(EBL)333795 035 $a(OCoLC)214281909 035 $a(SSID)ssj0000220589 035 $a(PQKBManifestationID)11196551 035 $a(PQKBTitleCode)TC0000220589 035 $a(PQKBWorkID)10143453 035 $a(PQKB)11588649 035 $a(MiAaPQ)EBC333795 035 $a(Au-PeEL)EBL333795 035 $a(CaPaEBR)ebr10226806 035 $a(CaONFJC)MIL123752 035 $a(PPN)243348118 035 $a(EXLCZ)991000000000407538 100 $a20080128h20082008 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aPharmaceutical manufacturing handbook $eregulations and quality /$f[edited by] Shayne Cox Gad 210 1$aHoboken, N.J. :$cWiley-Interscience,$d2008. 210 4$dİ2008 215 $a1 online resource (857 pages) 225 1 $aPharmaceutical Development Series 311 0 $a0-470-25959-0 320 $aIncludes bibliographical references and index. 327 $aPHARMACEUTICAL 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 PRACTICES 327 $a2.1 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 Perspectives 327 $a4.2 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 STABILITY 327 $a7.1 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; INDEX 330 $aWith its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. 410 0$aPharmaceutical Development Series;$v6 606 $aPharmaceutical technology$xQuality control$vHandbooks, manuals, etc 606 $aPharmacy$xLaw and legislation$zUnited States$vHandbooks, manuals, etc 606 $aDrugs$xLaw and legislation$zUnited States$vHandbooks, manuals, etc 615 0$aPharmaceutical technology$xQuality control 615 0$aPharmacy$xLaw and legislation 615 0$aDrugs$xLaw and legislation 676 $a615.19 676 $a615/.19 701 $aGad$b Shayne C.$f1948-$096171 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910785000603321 996 $aPharmaceutical manufacturing handbook$93781596 997 $aUNINA