biological products / in-process device / finished pharmaceuticals / study protocol / administered products / manufacturing environment / biological product / manufacturing design / risk management / aqueous-based pharmaceuticals / manufacturing / manufacturing practice / comparability protocol / certain biological products / therapeutic drug products / drug products / guidance Web page / veterinary product / manufacturing processes / manufacturing process / /
MusicGroup
Yes / /
Organization
Division of Manufacturing and Product Quality / U.S. Department of Health and Human Services / office of Communication / Outreach and Development / USP Chapter / Bacterial Endotoxins Test / 2 USP Chapter / Food and Drug Administration Center for Drug Evaluation and Research / Food and Drug Administration / Center for Devices and Radiological Health / office of Compliance / USP General Chapter / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation / Division of Drug Information / office of Regulatory Affairs / Association for the Advancement of Medical Instrumentation / Radiological Health / office of Communications / Endotoxins Test / 2 USP Chapter / Education and Radiation Programs Division of Small Manufacturers / Center for Veterinary Medicine / Center for Biologics Evaluation and Research / Photometric Quantitative Techniques / and USP Chapter / Center for Devices / /
Person
Silver Spring / / /
Position
representative / General / /
Technology
study protocol / Radiation / comparability protocol / process control / pdf / /
Guidance for Industry Pyrogen and Endotoxins Testing: