2003, FDA and Packaging - Pharmacy Technician Pulse

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2003

FDA

Packaging

CMC Requirements for New Drug Registration in Latin America

ISPE

MAY 9, 2023

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.

Documentation

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies

Air Speed Qualification: At Working Position or Working Level?

ISPE

SEPTEMBER 11, 2023

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.

Documentation

Documentation FDA Packaging Communication

CMC Requirements for New Drug Registration in Latin America

Air Speed Qualification: At Working Position or Working Level?

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