Temperature Excursion & Transportation Studies for Stability Program

Jul 25th, 2016
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Temperature Excursion & Transportation Studies for Stability Program ...

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Temperature Excursion &Transportation Studies forStability ProgramRELEASED - EFFECTIVE: 04-NOV-2013Sherry Guo, Ph.DManager, Global StabilityAbbott VascularDec 4, 2013SEDEARELTemperature Excursion and Stability Studies, IVTs Lab Compliance Week, Dec 3-5,2013, 2013 Abbott. All rights reserved. SE2939051, Rev AAgendaRELEASED - EFFECTIVE: 04-NOV-20131. Background, Scope and Purpose2. Strategic Consideration for TemperatureExcursion & Transportation Studies3. Design and Conduct Transportation Study4. Apply Transportation Study Results to QualitySystemDASEERELTemperature Excursion and Stability Studies, IVTs Lab Compliance Week, Dec 3-5, 2013,2013 Abbott. All rights reserved. SE2939051, Rev A2RELEASED - EFFECTIVE: 04-NOV-2013TerminologyExcursion:Temperature and other environmental conditionsexperienced by products outside of the registered specifiedranges.Transportation study:Study conducted to assess the effects of transportation onthe drug product, drug substance and excipient based onthe knowledge of the condition of transport (e.g., duration oftransport, expected temperatures during transport anddistribution, humidity, vibration, etc.). Conditions testedinclude but are not limited to thermal cycling or stress atDASEELelevated temperature.RETemperature Excursion and Stability Studies, IVTs Lab Compliance Week, Dec 3-5, 2013,2013 Abbott. All rights reserved. SE2939051, Rev A3RELEASED - EFFECT

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