Whitepaper: The necessity of E&L qualifications for lyophilised drug products
Lyophilised drug product containers and administration devices consist of the primary packaging, the reconstitution solution container, and the drug administration set.
Lyophilised drug product containers and administration devices consist of the primary packaging (typically a glass vial and a rubber stopper), the reconstitution solution container (typically a vial or a prefilled syringe system), and the drug administration set (such as a disposable syringe, an intravenous bag, or a pump system with administration tubing) as shown in the Whitepaper.
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Analytical techniques, Biologics, Biopharmaceuticals, Bioprocessing, Endotoxin, Excipients, Formulation, Good Manufacturing Practice (GMP), Labelling, Manufacturing, Medical Devices, Microbiology, Outsourcing, Packaging, QA/QC, Regulation & Legislation, Research & Development (R&D), Supply Chain