Technology Transfer: Drug Product Manufacturing Process by Ajay Babu Pazhayattil , Sanjay Sharma , Joe Paul Philip , Michelle Gischewski-Silva , Marzena Ingram
English | PDF EPUB (True) | 2023 | 158 Pages | ISBN : 303132191X | 27.1 MB
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.