2004 Compounding Process Improvement 
ISPE
SEPTEMBER 11, 2023
Examples include platforms as small as autonomous units placed within a facility and mobile production trailers for compounding to platforms as large as a prefabricated, self-contained GMP facility. September 2004. Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice.” September 2004.
ISPE
AUGUST 30, 2022
With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Burke, PhD. 1 September 2022. A reliable supply of raw materials is critical to maintain a robust supply chain to serve patients globally. 6 US Food and Drug Administration. Burke, S., Hammond, and T.
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