LEADER 04253nam 22007335 450 001 9910731465203321 005 20230616163935.0 010 $a3-031-32192-8 024 7 $a10.1007/978-3-031-32192-4 035 $a(MiAaPQ)EBC30602000 035 $a(Au-PeEL)EBL30602000 035 $a(DE-He213)978-3-031-32192-4 035 $a(PPN)272266914 035 $a(CKB)27060369900041 035 $a(EXLCZ)9927060369900041 100 $a20230616d2023 u| 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aTechnology Transfer $eDrug Product Manufacturing Process /$fby Ajay Babu Pazhayattil, Sanjay Sharma, Joe Paul Philip, Michelle Gischewski-Silva, Marzena Ingram 205 $a1st ed. 2023. 210 1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2023. 215 $a1 online resource (158 pages) 225 1 $aAAPS Introductions in the Pharmaceutical Sciences,$x2522-8358 ;$v10 311 08$aPrint version: Pazhayattil, Ajay Babu Technology Transfer Cham : Springer International Publishing AG,c2023 9783031321917 327 $aChapter 1: Current Status of Technology Transfer -- Chapter 2: Quality by Design (QbD) Process Design -- Chapter 3: Quality Risk Management (QRM) -- Chapter 4: Technology Transfer Process -- Chapter 5: Scaling-Up of Solid Orals: Granulation, Drying, Size Reduction, Blending, Compression, and Coating Technologies -- Chapter 6: Qualification, Continued Process Verification, and Lifecycle Management -- Chapter 7: Continuous Improvement Case Study: Transforming Legacy Products. 330 $aCurrently, there are no textbooks on drug product manufacturing technology transfer that incorporate the latest regulatory expectations. Recent guidance from regulatory bodies such as the US FDA, EMEA, WHO, and PIC/S has adopted the ICH Lifecycle approach harmonizing concepts across regulatory guidance. This allows organizations to align their technology transfer activities for all regulated markets. However, there is a need for consensus and direction in approaching technology transfer, particularly in understanding how to manage the scale-up effects to ensure regulatory compliance. This textbook offers technology transfer solutions and guidance to the pharmaceutical industry. The chapters provide a systematic understanding of applying the technology transfer concepts in pharmaceutical manufacturing, promoting standardization within the industry. Since Stage 1b is not specified in detail within the regulations, pharmaceutical organizations are left to determine the requirements of the stage. The need to justify the methodologies and utilization of sound science makes it more demanding. The textbook?s authors provide innovative solutions for technology transfer challenges, making it a comprehensive reference document. The approaches can be applied to both small-molecule and large-molecule drug product manufacturing segments, addressing the unmet needs of the industry. 410 0$aAAPS Introductions in the Pharmaceutical Sciences,$x2522-8358 ;$v10 606 $aPharmacy 606 $aPharmaceutical chemistry 606 $aPharmacology 606 $aDrug delivery systems 606 $aPharmacovigilance 606 $aPharmacy 606 $aPharmaceutics 606 $aPharmacology 606 $aDrug Delivery 606 $aDrug Safety and Pharmacovigilance 615 0$aPharmacy. 615 0$aPharmaceutical chemistry. 615 0$aPharmacology. 615 0$aDrug delivery systems. 615 0$aPharmacovigilance. 615 14$aPharmacy. 615 24$aPharmaceutics. 615 24$aPharmacology. 615 24$aDrug Delivery. 615 24$aDrug Safety and Pharmacovigilance. 676 $a615.1 676 $a615.19 700 $aPazhayattil$b Ajay Babu$01057742 701 $aSharma$b Sanjay$0882232 701 $aPhilip$b Joe Paul$01369119 701 $aGischewski-Silva$b Michelle$01369120 701 $aIngram$b Marzena$01369121 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910731465203321 996 $aTechnology Transfer$93395214 997 $aUNINA