| Document Date: 2003-12-22 17:39:38
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Company Ethyl / / Country United States / / Event Product Issues / Reorganization / / Facility Terminal Sterilization / / IndustryTerm rubber stoppers / aseptic manufacturing operations / aseptic processing / sterile drug products / adjunct processing / conventional manufacturing / particular site / appropriate challenge simulating normal processing / sterilized products sterile drug products / drug product / actual processing operation / processed product / study protocol / routine aerobic media / manufacturing deficiency / system processing / sterilized product / sterile drug product / batch processing circumstances / parenteral products / to terminally sterilized products / sterile product / manufacturing / aseptic processing areas / rubber stopper / aseptic processing vs. / pharmaceutical / individual media / aseptic processing operation / validated closed systems / manufacturing situations / aseptic processing production problems / aseptic processing operations / aseptic processing area / drug products / aseptic processing facility / media fills / sterilized products / aseptic processing facility monitoring program / manufacturing processes / / Organization FDA / European Union / USP / / / Position experienced microbiologist / Section Guidance Line Comment Rationale General / representative / General / sterilizer / microbiological results Sterilizer / / Product vial / units / glove / laboratory / unit / / ProvinceOrState Quebec / / PublishedMedium The EU guide / / Technology alpha / study protocol / laser / simulation / Process Control / /
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SCORECARD: PhRMA Comments on: Draft FDA Guidance “Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice” [Docket No. 2003D–0382] September 2003