ICH Quality Implementation Working Group / F. Software Solutions / Quality Implementation Working Group / /
Continent
Europe / /
Country
Japan / United States / /
Currency
pence / / /
Event
FDA Phase / /
Facility
Rockville Pike / / /
IndustryTerm
Manufacturing data / manufacturing flexibility / stability monitoring protocol / structured way to define product / end product / process validation protocols / risk management / manufacturing practice / manufacturing records / manufacturing process / final product / real-time release testing mean elimination / term real time release / on-line/in-line measurement / scale manufacturing / real-time release testing / manufacturing operations / real-time release / manufacturing process changes / /
Organization
U.S. Department of Health and Human Services / office of Communication / Outreach and Development / Food and Drug Administration Center for Drug Evaluation and Research / Food and Drug Administration / Food and Drug Administration Center for Drug Evaluation / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / ICH Steering Committee / European Federation of Pharmaceutical Industries and Associations / European Union / office of Communications Division of Drug Information / Center for Biologics Evaluation and Research / Center for Biologics Evaluation and Research Food and Drug Administration / /
Person
Silver Spring / Stephan Roenninger / Rafael Beerbohm / Fritz Erni / Chris Potter / Gordon Muirhead / Alastair Coupe / / /
Microsoft Word - 9849fnl[removed]doc