Aseptic processing

Results: 176



#Item
61Food science / Packaging / Hygiene / Aseptic technique / Science / Aseptic processing / Sterilization / Validation / Moist heat sterilization / Medicine / Health / Pharmaceutical industry

ALCON LABORATORIES, INC[removed]SOUTH FREEWAY FORT WORTH, TEXAS[removed][removed]Dockets Management Branch (HFA-305)

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Source URL: www.fda.gov

Language: English - Date: 2003-11-20 08:28:12
62Hygiene / Cleanroom / Rooms / Semiconductor device fabrication / Health / Manufacturing / Sterilization / Aseptic processing / HEPA / Filters / Microbiology / Technology

Re: Docket Number 2003D-0382 Comments on Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice, August 2003 Draft

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Source URL: www.fda.gov

Language: English - Date: 2003-10-28 17:03:54
63Food science / Packaging / Food and Drug Administration / Medicinal chemistry / Pharmaceutical sciences / Clinical research / Aseptic processing

AUG[removed] :46 From:[removed]

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Source URL: www.fda.gov

Language: English
64Technology / Aseptic processing / Food science / Cleanroom / Form FDA 483 / Food and Drug Administration / Packaging / Pharmaceutical sciences / Clinical research

Inspectional observations

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Source URL: www.fda.gov

Language: English
65Filters / Building biology / HEPA / Quality / ISO 14644-7 / Validation / Film speed / Comment / Sterilization / Computing / Information / Computer programming

Packaging Technology Division C:\Documents and Settings\dub4cr\My Documents\my files\Comments to FDA Aseptic Processing Draft.2003 Nov.doc, by BD, [removed] page 1 of 4

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Source URL: www.fda.gov

Language: English - Date: 2003-12-05 09:20:37
66Chemical engineering / Building biology / Hygiene / HEPA / Sterilization / Air filter / Filtration / Dust / Aseptic processing / Chemistry / Filters / Technology

d Comments Comment Number

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Source URL: www.fda.gov

Language: English - Date: 2003-12-10 17:34:38
67Packaging / Health / Pharmaceutical industry / Aseptic processing / Food science / Aseptic technique / Sterilization / HEPA / Barrier isolator / Technology / Quality / Science

SCORECARD: PhRMA Comments on: Draft FDA Guidance “Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice” [Docket No. 2003D–0382] September 2003

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Source URL: www.fda.gov

Language: English - Date: 2003-12-22 17:39:38
68Chemistry / Aseptic processing / Air filter / HEPA / Water filter / Food and Drug Administration / Cleanroom / Filters / Technology / Manufacturing

Bristol-Myers Squibb PharmaceuticalResearchInstitute PO Box4000 Prmdun,NJ08543[removed]4000 T /; 7 "? "03

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Source URL: www.fda.gov

Language: English - Date: 2003-12-08 14:23:38
69Packaging / Pharmaceutical industry / Food science / Hygiene / Aseptic processing / Sterilization / Validation / Autoclave / Moist heat sterilization / Medicine / Health / Technology

Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.

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Source URL: www.fda.gov

Language: English - Date: 2003-09-02 04:48:59
70Packaging / Science / Food science / Aseptic processing / Containers / Packaging and labeling / Validation / Blow fill seal / Technology / Pharmaceutical industry / Business

To: Dockets Management Branch (HFA-305) Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, USA Regarding: Comments on Draft Guidance for industry: Sterile Drug Products Produced by Aseptic Pr

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Source URL: www.fda.gov

Language: English - Date: 2003-12-08 14:23:30
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