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Kraft Information Systems 1 Stability Studies Overview, Setup, Setup, Creation, Special Scenarios and Opportunities August 2009

Stability Studies QM

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Stability studies used in Pharma ,food and process industries

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Slide 1Stability Study:
The objective of a stability study is to determine the shelf-life, the time period of storage at a specified condition within which the product still meets its established specifications.
The business need for stability studies:
Consumer Products Industry
Expiry date determination
Retest samples (in case of complaints)
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QP02 – Create Inspection Plan
QST09 – Create Building Block
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Inspection type setup for stability studies in the material master:
16, 1601, 1602, Z8NA006
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Greenberg, David (Contractor) (DG) - same comment re z89 spell out active and preferred settings 1602 active and preferred, rest active
Kraft Information Systems
Create Insp Plan
Inspection Plan Group Y* for Stability Studies
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Greenberg, David (Contractor) (DG) - spell out naming convention for stability study groups y+plant+XXX where XXX is the shelf life padded by leading 0.
Kraft Information Systems
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Greenberg, David (Contractor) (DG) - add details next few slides - good screenshots.
Kraft Information Systems
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The end user process for day to day creation of stability studies.
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Select from Favorites
Kraft Information Systems
1. Select the Stability Study BB. This is the shelf life/SLED of the sample:
- Y90
- Y95
- Y100
Material number
Plant number
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2. Enter Description
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2. Notification/ Lab number can be viewed
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CLICK on Initial
Test Inspection Lot
2. Click on Ok for print out
If the printout does not work, write the Batch# on the box with a marker.
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Inspection lot with results, reject, defect, cancel study
Cancel without results
Type in QM02 and Enter, or Select from Favorites
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transaction, fill in Notification Date, Notification
type and Material # (if known), then click execute
to view Notifications
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Kraft Information Systems
2. The Study status is now indicated as canceled as displayed next to the blue exclamation mark.
1. Click on the Save icon
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