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A Better Approach To Aseptic Process Simulation For Lyophilized Products
By David A. Hamilton (MSD), Ted Tharp (AbbVie), Orla McGarvey (Lonza), Martin Frei (Lonza), Michael Dekner (Takeda), Shyam B. Mehta (Teva Pharmaceuticals), Xiaodong Chen (Bristol Myers Squibb), Nunzio Zinfollino (Merck), Stefan Schneid (Bayer), Josh Briggs (Biogen), Melissa Schreyer (Janssen Research & Development), and Deborah Hill (BioPhorum)
Proposed 2020 revisions to EU Annex 1
1 with respect to aseptic process simulation (APS) for lyophilized products have prompted extensive discussions on best practices for process simulation of the lyophilization unit operation. This article serves to address these expectations and present a risk-based, holistic best practice approach for APS for lyophilized drug products. ....

States Pharmacopeia , National Formulary , Inspection Convention , United States Pharmacopeial Convention , Sterile Medicinal Products , Good Manufacturing Practice Vol , Pharmaceutical Inspection , Process Simulations , Lyophilized Products , Pharmaceutical Freeze Drying , மாநிலங்களில் மருந்தகம் , தேசிய சூத்திரம் , ஆய்வு மாநாடு , மலட்டு மருத்துவ ப்ராடக்ட்ஸ் , மருந்து ஆய்வு ,