In October , FDA issued a draft guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities: Guidance for Industry, which describes how the FDA is operating their remote evaluations program, the logistics of its implementation, and what they expect of industry. The public comment period ends December 26.
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PHARMA ONLINE WHITE PAPERS
Impact Of Freeze-Drying Process And Lyoprotectants On Nanoparticle Stability
Read highlights from a recent webinar describing the challenges of freeze-drying nanoparticles and how a group has designed and evaluated solutions to lyophilizing LNPs.
Selecting The Locations Of Particle Monitoring For The Fill-Finish Process4/28/2022
Learn about the monitoring of particles (viable and non-viable) during the fill-finish process of drug manufacturing and considerations for the location of airborne particle monitors.
Monkeypox Vaccine: What To Expect9/21/2022
We answer your most pressing questions about how the monkeypox vaccine works and how it’s manufactured.
The Business Value Of Connectivity For Product Inspection Equipment3/16/2022
Realize the value of connectivity, and more specifically, the value of information provided by checkweighing, metal detection, vision inspection, and x-ray inspection.
Bench To Bedside: A Scalable End-To-End Solution For AAV Production8/30/2022
How to efficiently translate bench-scale processes to commercial GMP manufacturing to produce viral vectors at the scale needed to meet dosage requirements.
Modern Manufacturing: The Investment in Digitization Costs Less Than Falling Behind2/1/2022
By adopting digital solutions today, manufacturers can capitalize on the opportunities of modern manufacturing solutions and realize their full potential.
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
On the surface, the future laboratory looks like an end to paper notebooks, adding solar panels on the roof, and lots of automation. But those are just the trimmings for a greater transformation as laboratories modernize. Check out the latest e-book from Pharmaceutical Online.More Content Collections