TY  - BOOK
AU  - Pazhayattil,Ajay Babu
AU  - Sharma,Sanjay
AU  - Philip,Joe Paul
AU  - Gischewski-Silva,Michelle
AU  - Ingram,Marzena
ED  - SpringerLink (Online service)
TI  - Technology Transfer: Drug Product Manufacturing Process 
T2  - AAPS Introductions in the Pharmaceutical Sciences,
SN  - 9783031321924
AV  - RS1-441 
U1  - 615.1 23
PY  - 2023///
CY  - Cham
PB  - Springer International Publishing, Imprint: Springer
KW  - Pharmacy
KW  - Pharmaceutical chemistry
KW  - Pharmacology
KW  - Drug delivery systems
KW  - Pharmacovigilance
KW  - Pharmaceutics
KW  - Drug Delivery
KW  - Drug Safety and Pharmacovigilance
N1  - Acceso multiusuario; Chapter 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
N2  - Currently, 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
UR  - http://libcon.rec.uabc.mx:2048/login?url=https://doi.org/10.1007/978-3-031-32192-4
ER  -