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Process improvements and in-person monitoring help U.S. pharmaceutical company achieve on time for Phase III clinical trials

Impact Pharmaceutical Services

pharmaceutical company to oversee a 6 month, DS manufacturing as Person-In- Plant (PIP) and assist with preparation of associated submission documents related to Phase III clinical trial batches. Download The Case Study The post Process improvements and in-person monitoring help U.S.

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

www.fda.gov/media/162157/download 7 Okwudire, C. Subsequently, the new data is authored into Module 3 (Quality) of the Common Technical Document and submitted separately to multiple health authorities worldwide for approval. www.fda.gov/media/71023/download 50 Yu, L. Discussion paper. October 2022. Madhyastha. Science 372, no.