Communication FDA Packaging Webinar 
ISPE
JANUARY 10, 2023
The strategy is to provide an appropriate characterization package that demonstrates the alternative filter or resin will not impact product quality, submit it in a PAS, and, if needed, submit a request for an expedited review. US Food and Drug Administration webinar. 3 Ramanadham, M. Published 3 September 2021.
ISPE
AUGUST 29, 2022
For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. ICH Q12: Implementation Considerations for FDA-Regulated Products Guidance for Industry.” Draft Guidance for Industry.
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Pharmaceutical Technology
MARCH 22, 2023
According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.
Pharmaceutical Technology
NOVEMBER 30, 2022
A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. Free Webinar. The evolution of CCIT. Wallis and Futuna.
Pharmaceutical Technology
FEBRUARY 23, 2023
Fraction absorbed is directly related to the solubility, dissolution, and permeability of a compound and is the amount of drug that enters the intestinal enterocyte in our gastrointestinal tract (FDA definition), whereas bioavailability (F) is the amount of drug in the systemic circulation able to have a therapeutic effect.
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