European Pharmaceutical Review

MAY 29, 2023

Recently, the European Medicines Agency (EMA) took the lead in pushing for process improvements using technologies already established in other manufacturing sectors. Despite this, only 13 nanomedicines had been approved by the US Food and Drug Administration (FDA) before 2015.

Process Improvement 67

Process Improvement Packaging Vaccines FDA 67

ISPE

SEPTEMBER 11, 2023

Pharmaceutical Processing World. 1 May 2015. Developing the Biofacility of the Future Based on Continuous Processing and Single-Use Technology.” Journal of Biotechnology 213 (2015):120–30. Rockville, MD: US Pharmacopeial Convention, 2015. Quality Considerations for Aseptic Processing.” 12 April 2016.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

AUGUST 29, 2022

Following approval of an initial marketing application, postapproval changes are needed to ensure adequate supply, mitigate supply risk, expand patient market access, optimize manufacturing processes, improve analytical methods, and comply with new regulatory expectations. Pharmaceutical Engineering 41, no. Draft Guidance for Industry.

Documentation 52

Documentation FDA Communication Packaging 52