sterile equipment / finished parenteral manufacturers / lasting solution / dosage form manufacturers / aseptic processing line / repeat media fill / parenteral product / pharmaceutical industry / sterile active pharmaceutical ingredient / change control systems / pharmaceutical operation / final processing steps / pharmaceutical manufacturer / manufacturing practices / manufacturing systems / aseptic processing equipment / actual processing parameters / finished prod119 uct manufacturer / environmental monitoring systems / parenteral products / sterile product / tablet products / manufacturing practice / aseptic processing operations / personnel-intensive aseptic processing / closed and semi-closed systems / media fills / manufacturing approach / aseptic processing room / exposed sterile product / aseptic processing / processed products / quality management / actual manufacturing process / manufacturing operation / aseptic manufacturing operation / media fill / unacceptable water systems / parenteral drug product / aseptic processing case studies / well-conceived media / manufacturing equipment / aseptic processing contamination problems / pharmaceutical manufacturing / manufacturing operations / blow/ fill/seal equipment / early warning needed to prevent product / aseptic processing industry / drug products / aseptic processing area / pharmaceutical quality / unsuitable equipment / finished dosage form site / unsuitable processing equipment / /
MedicalCondition
PDA / Pseudomonas / sterility / good prior sterility / repeated sterility / septicemia / both sterility / /
Organization
US Printing Office / Center for Drug Evaluation & Research / Food and Drug Administration / International Society / Drug Association / Parenteral Drug Association / U.S. Securities and Exchange Commission / R. Chapter / US Food & Drug Administration / Pharmaceutical Quality System Richard L. Friedman Food & Drug Administration / European Commission / Division of Manufacturing / FDA Advisory Committee for Pharmaceutical Science / Manufacturing Subcommittee / European Union / Advisory Committee for Pharmaceutical Science / International Society for Pharmaceutical Engineering / /
Person
Friedman / Prince / /
Position
consultant / Prince / evaluator / writer / Major / representative / Porter / /
Product
filters / No contamination struction / raw materials / drug / water / operational design One / /
ProgrammingLanguage
DC / /
ProvinceOrState
Illinois / Pennsylvania / /
Technology
API / process control / Validation Technology / Barrier Isolation Technology / SIP technology / simulation / PDA / manufacturing the API / /
COMMENTARY Aseptic Processing Contamination Case Studies and the Pharmaceutical Quality System Richard L. Friedman Food & Drug Administration, Center for Drug Evaluation & Research, Division of Manufacturing & Product Q