2004, FDA and Process Improvement - Pharmacy Technician Pulse

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2004

FDA

Process Improvement

Considerations for a Decentralized Manufacturing Paradigm

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.

Health and Personal Care Stores

Health and Personal Care Stores Vaccines Packaging Documentation

Regulatory Landscape for Raw Materials: CMC Considerations

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.

Documentation

Documentation FDA Packaging Communication

Considerations for a Decentralized Manufacturing Paradigm

Regulatory Landscape for Raw Materials: CMC Considerations

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