ISPE

MARCH 29, 2023

Application of this innovative approach will quickly orient regulators to the content of Module 3, “present product quality benefit-risk considerations, summarize the pharmaceutical development, present an overall understanding of the product quality,” 1 and facilitate continuous improvement. 2005N–0262) Federal Register (2005).

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Application of this innovative approach will quickly orient regulators to the content of Module 3, “present product quality benefit-risk considerations, summarize the pharmaceutical development, present an overall understanding of the product quality,” 1 and facilitate continuous improvement. 2005N–0262) Federal Register (2005).

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

SEPTEMBER 11, 2023

Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice.” Aseptic Processing: A Vision of the Future.” 2 (1 May 2005). Product Focus: Advancing Aseptic Processing.” FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.” September 2004. 20 Parrish, M.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

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 52

Documentation FDA Packaging Communication 52