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Gamma Sterilization Process DMFs Harmonized

West Regulatory Affairs (RA) has a goal of harmonizing site-specific Drug Master Files (DMFs) into a global document as the processes at different facilities are synchronized.

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Janet Gaboury, PhD

Sr. Specialist Regulatory Affairs

Westar Sterilization Process DMFs Pharmaceutical Gamma Sterilization Process

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以前的博客

十二月 30, 2013

Plunger Machinability: Steam vs Gamma

Simon Cote

Principal SME, Seals

Steam Gamma Sterilization Plungers

二月 05, 2013

An Evaluation Of The Impact Of Sterilization Processes On Elastomeric Container Closure Components Used To Store And Administer Parenteral Drug Products

Amy Miller & Wayne Curry

Science Poster Elastomer Extractables Gamma Leachables Quality

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Gamma Sterilization Process DMFs Harmonized

{1}

Plunger Machinability: Steam vs Gamma

An Evaluation Of The Impact Of Sterilization Processes On Elastomeric Container Closure Components Used To Store And Administer Parenteral Drug Products

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