expected and documented manufacturing losses / pharmaceutical development / manufacturing controls / manufacturing experience / container closure systems / drug product / analytical technology / manufacturing process improvements / quality risk management / lifecycle management / manufacturing process options / final formulated product / pharmaceutical and manufacturing sciences / real-time quality control / manufacturing process development program / physical and chemical attributes / drug products / pharmaceutical development studies / manufacturing processes / manufacturing process / /
Organization
U.S. Department of Health and Human Services / Food and Drug Administration Center for Drug Evaluation and Research / fda / office of Communication / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / European Union / ICH Steering Committee / office of Communications Division of Drug Information / Center for Biologics Evaluation and Research / Center for Biologics Evaluation and Research Food and Drug Administration / / /
Product
M-16 / R2 / /
ProvinceOrState
Maryland / /
Technology
Biotechnology / process control / drug development / /