Download this guidance on Pharmaceutical Stability Study with SAP S/4HANA part 2/2
Guidance Vietnamese Version.pdf
Table of contents
1. Create Inspection Plan for 2 conditions: QP01
2. Create test schedule for 2 Inspection Plan: CWBQM
3. Create Batches for Stability study (With Product don’t have available in SAP): MSC1N
4. Create Notification for stability study (Protocol): QM01
5. Create/ change Initial Sample (Sampling plan): QM02
6. Confirm Initial Sample (Sample Receiving): QM02
7. Initial Test for Stability sample: QM02
8. Record Testing Results of Initial sample: QA32
9. Complete Initial Test: QM02
10. Specify Storage Conditions: QM02
11. Create/ change Testing schedule: QM02
12. Store stability samples: QM02
13. Complete Test Scheduling: QM02
14. Define Start Date of Study: QM02
15. Maintenance Plan (testing schedule): IP 24
16. Edit Maintenance Plan: IP10
17. Call the Tests for stability study: IP30
18. Record the testing results: QA32
19. Show Stability study table result: QM02
20. Complete stability study: QM02
7. Initial Test for Stability sample: QM02
Step 1: Click on .
Step 2: Fill Group and Group Counter according to 1 of 2 conditions: Accelerated condition or Long-term conditio. Fill short text or stay it empty. Then click on Inspection Lot
Step 3: Tick Criterias that you want to test. If you want to test all criterias, you can click on Copy All . If you want to test some of them, you can tick these criterias and click on V icon.
8. Record Testing Results of Initial sample: QA32
Step 1: Access Tcode QA32. Fill Material code>> Click on Clock icon or press F8
Step 2: Click to row that contains Inspection Lot of Initial sample >> Click on More>> Choose Change Inspection results.
Step 3: Click Assigned Insp. Points and record results into the Result column and click on Save.
Step 4: Make Decision on the Test: Tick on the row >> click on More >> choose Change Usage Decision
At UD Code: click on Search Icon, then click on Yes
Double click on A and save if Testing results are passed. Then Exit this Tcode.
9. Complete Initial Test: QM02
Step 1: Access Tcode: QM02. Fill Notification code>> Press Enter or click on Notification.
Step 2: Click on Complete Initial test
10. Specify Storage Conditions: QM02
– Click on Specify Storage Conditions:
– Fill sample quantity at conditions: Total quantity sample equal quantity of Initial sample
– Tick on the rows that are filled
– Click on Save And Change Notification
Can add and delete conditions by click on
– Specify Add. Storage Conds
– Delete Storage Condition
11. Create/ change Testing schedule: QM02
Create Testing Schedule. Click on Created Testing Schedule
– Maintenance Plan: =>> Please remember this code
– Maint. Plan cat.: fill ST
– Maintenance Strategy: fill QSTABI
– Scheduling period and Unit
– Inspection Type: Default is 16
– Click on Save And Change Notification
Change Testing schedule.
Step 1: Click on Change Testing Schedule >> Choose Yes
Step 2: Click on tab Maintenance plan scheduling parameters:
– Factory calendar choose your country
– Start of cycle:
– Scheduling indicator: Choose Time – factory caldr
Step 3: Click on tab Maintenance plan additional data: Enter Key date
Step 4: At Tab Item overview: Tick on Item that want to sign the schedule >> then click on Item: and go down:
Step 5: Enter Group and Group Counter: correctly with condition that you select recently. Click on tab Cycle Item to check the schedule that is signed.
Step 6: Go back to Tab Item overview and do these activities again with the other condition. Tick row 2 and go to Tab Item.
Step 7: Enter the other Group và Group Counter. Go to tab Cycle Item to check.
Check:
Click Save to complete the Testing schedule.
12. Store stability samples: QM02
Step 1: Click on Store Stability Samples
Step 2:
– Enter Location into Sample Location column.
– Enter Storage date (Same or before start date of study). If you enter Storage date after start date of study, you have to create a new notification.
Tick all rows , then click on Save and Change Notification.
13. Complete Test Scheduling: QM02
Click on Complete Test Scheduling>> Choose Yes
14. Define Start Date of Study: QM02
Click on Define Start Date of Study. Enter the date and click on Save And Change Notification.
Notice: In SAP, study records only results from now, not from the Start date of study. The timepoints in the past can not record testing results.
Initial Sample Creation Date <= Initial Sample Confirmation Date <= Store Stability Sample Date <= Start Date of Study.
15. Maintenance Plan (testing schedule): IP 24
Access Tcode IP24
Enter Maintenance Plan code , then click on Clock icon or Press F8
16. Edit Maintenance Plan: IP10
Access Tcode IP10
Enter Maintenance Plan >> Press Enter. Edit and save.
Release call: call Inspection lot for this time point
Fix call: edit testing date
Skip call: skip test in this time point
17. Call the Tests for stability study: IP30
Access Tcode: IP30
Step 1: Enter Maintenance Plan >> press Enter.
Step 2: Enter information and click on Clock icon and waiting for complete.
– Maintenance Plan:
– Maintenance Strategy: enter QSTABI
– Interval for Call Objects: Period you want to call from now. Unit: Day, Mon, Yr
18. Record the testing results: QA32
Do the same with item 8. Record Testing Results of Initial sample
19. Show Stability study table result: QM02
Step 1: Access Tcode: QM02 and enter Notification code >> press Enter
Step 2: Click on Display Stability History at Action box.
Go to Tab 30ºC or 40 ºC to see the results.
Click on Export icon to export to excel file.
20. Complete stability study: QM02
Finish stability study:
– Click on Complete Stability Study and save to finish.
Complete stability study:
– Click on Flag icon or Complete or Shift + F9: Enter date, time and choose Internal Origin >> then click on V icon
After study completed, the Action box would be like that:
Guidance on Pharmaceutical Stability Study with SAP S/4HANA Part 1/2
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