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Technology Transfer: Drug Product Manufacturing Process
Hardcover
Series: Aaps Introductions in the Pharmaceutical Sciences, Book 10
ISBN13: 9783031321917
Publisher: Springer Nature
Published: Jun 17 2023
Pages: 148
Weight: 0.90
Height: 0.44 Width: 6.14 Depth: 9.21
Language: English
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.
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