2004 FDA Process Improvement 
ISPE
SEPTEMBER 11, 2023
September 2004. Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice.” September 2004. Aseptic Processing: A Vision of the Future.” Product Focus: Advancing Aseptic Processing.” FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.” 12 July 2019.
ISPE
AUGUST 30, 2022
In addition, single-use technologies have been increasingly employed throughout manufacturing because of the advantages they offer, including reductions in cost, manufacturing footprint, contamination risk, and processing times (Figure 1). There is undoubtedly a need for improved supply chain flexibility to address shortages.
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