Technology Transfer: Drug Product Manufacturing Process

by Sanjay Sharma, Ajay Babu Pazhayattil, Joe Paul Philip

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...

• Format: Paperback
• Language: English
• ISBN: 3031322193
• ISBN13: 9783031322198
• Release Date: June 2024
• Publisher: Springer
• Length: 148 Pages