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Packaging / 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(HFA-305) Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, USA Regarding: Comments on Draft Guidance for industry: Sterile Drug Products Produced by Aseptic Pr
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Document Date: 2003-12-08 14:23:30

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File Size: 578,80 KB

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City

Rockville / /

Company

Blow-Fill-Seal Technology / AstraZeneca / /

Country

United States / /

Event

Product Issues / /

/

IndustryTerm

aseptic processing / routine processing / pharmaceutical industry / pharmaceutical production / particulate contamination products / machinery / sterile drug product / sterile product / manufacturing / aseptic processing characteristics / media fills / contaminated media / blow-fillseal technology / /

Organization

PharmaceuticalBlow-Fill-Seal International Operators Association / Food and Drug Administration / Pharmaceutical Blow-Fill-Seal International Operators Association / PDA / European Union / /

Person

Bengt Ljungqvist / Friedman / Max Volume / Uratani / Berit Reinmuller / Filling Line / /

/

Position

SVP / General / international Technical Officer / Excerpts General / /

Product

media / /

ProvinceOrState

Maryland / /

Technology

blow-fillseal technology / PDA / /

SocialTag