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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.
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