Remove 2003 Remove Communication Remove Packaging
article thumbnail

A New Regulatory Approach to Drive Sustainable Medicines

ISPE

As such there’s a growing question of how the industry will improve the sustainability profile of its existing medicines and ensure that sustainability is designed into new medicines, such as products, with a reduced environmental risk, greener manufacturing technologies, and recyclable delivery systems and packaging. 9 December 2021.

article thumbnail

CMC Requirements for New Drug Registration in Latin America

ISPE

In addition to the COR, some Latin American markets require approval in the COO, which is defined as the country where the drug is manufactured, packaged, or exported from. Sometimes, COAs for the drug substance, the excipients used in the formulation, and the primary and nonfunctional secondary packaging material are requested.

article thumbnail

Air Speed Qualification: At Working Position or Working Level?

ISPE

m/s recommendation made its way into the US Food and Drug Administration (FDA)’s “Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice” 7 and into the EC GMP Annex 1 “Manufacture of Sterile Medicinal Products” in 2003. x, a free and open-source computational fluid dynamics (CFD) software package.