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Paperback Technology Transfer: Drug Product Manufacturing Process Book

ISBN: 3031322193

ISBN13: 9783031322198

Technology Transfer: Drug Product Manufacturing Process

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...

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Format: Paperback

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