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
![Pharmaceutical Stability Study with SAP 7 step 2](https://thangtv.net/wp-content/uploads/2021/01/Pharmaceutical-Stability-Study-with-SAP-7-step-2.jpg)
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.
![Pharmaceutical Stability Study with SAP 7 step 3](https://thangtv.net/wp-content/uploads/2021/01/Pharmaceutical-Stability-Study-with-SAP-7-step-3.jpg)
8. Record Testing Results of Initial sample: QA32
Step 1: Access Tcode QA32. Fill Material code>> Click on Clock icon or press F8
![Pharmaceutical Stability Study with SAP 8 step 1](https://thangtv.net/wp-content/uploads/2021/01/Pharmaceutical-Stability-Study-with-SAP-8-step-1.jpg)
Step 2: Click to row that contains Inspection Lot of Initial sample >> Click on More>> Choose Change Inspection results.
![Pharmaceutical Stability Study with SAP 8 step 2](https://thangtv.net/wp-content/uploads/2021/01/Pharmaceutical-Stability-Study-with-SAP-8-step-2.jpg)
Step 3: Click Assigned Insp. Points and record results into the Result column and click on Save.
![Pharmaceutical Stability Study with SAP 8 step 3](https://thangtv.net/wp-content/uploads/2021/01/Pharmaceutical-Stability-Study-with-SAP-8-step-3.jpg)
Step 4: Make Decision on the Test: Tick on the row >> click on More >> choose Change Usage Decision
![Pharmaceutical Stability Study with SAP 8 step 4](https://thangtv.net/wp-content/uploads/2021/01/Pharmaceutical-Stability-Study-with-SAP-8-step-4.jpg)
At UD Code: click on Search Icon, then click on Yes
![Pharmaceutical Stability Study with SAP 8 step 4 2](https://thangtv.net/wp-content/uploads/2021/01/Pharmaceutical-Stability-Study-with-SAP-8-step-4-2.jpg)
Double click on A and save if Testing results are passed. Then Exit this Tcode.
![Pharmaceutical Stability Study with SAP 8 step 4 3](https://thangtv.net/wp-content/uploads/2021/01/Pharmaceutical-Stability-Study-with-SAP-8-step-4-3.jpg)
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
![Pharmaceutical Stability Study with SAP 10](https://thangtv.net/wp-content/uploads/2021/01/Pharmaceutical-Stability-Study-with-SAP-10.jpg)
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
![Pharmaceutical Stability Study with SAP 11](https://thangtv.net/wp-content/uploads/2021/01/Pharmaceutical-Stability-Study-with-SAP-11.jpg)
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
![Pharmaceutical Stability Study with SAP 11 step 2](https://thangtv.net/wp-content/uploads/2021/01/Pharmaceutical-Stability-Study-with-SAP-11-step-2.jpg)
Step 3: Click on tab Maintenance plan additional data: Enter Key date
![Pharmaceutical Stability Study with SAP 11 step 3](https://thangtv.net/wp-content/uploads/2021/01/Pharmaceutical-Stability-Study-with-SAP-11-step-3.jpg)
Step 4: At Tab Item overview: Tick on Item that want to sign the schedule >> then click on Item: and go down:
![Pharmaceutical Stability Study with SAP 11 step 4](https://thangtv.net/wp-content/uploads/2021/01/Pharmaceutical-Stability-Study-with-SAP-11-step-4.jpg)
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.
![Pharmaceutical Stability Study with SAP 11 step 5](https://thangtv.net/wp-content/uploads/2021/01/Pharmaceutical-Stability-Study-with-SAP-11-step-5.jpg)
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.
![Pharmaceutical Stability Study with SAP 11 step 6](https://thangtv.net/wp-content/uploads/2021/01/Pharmaceutical-Stability-Study-with-SAP-11-step-6.jpg)
Step 7: Enter the other Group và Group Counter. Go to tab Cycle Item to check.
![Pharmaceutical Stability Study with SAP 11 step 7](https://thangtv.net/wp-content/uploads/2021/01/Pharmaceutical-Stability-Study-with-SAP-11-step-7.jpg)
Check:
![Pharmaceutical Stability Study with SAP 11 step 7 2](https://thangtv.net/wp-content/uploads/2021/01/Pharmaceutical-Stability-Study-with-SAP-11-step-7-2.jpg)
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.
![Pharmaceutical Stability Study with SAP 12](https://thangtv.net/wp-content/uploads/2021/01/Pharmaceutical-Stability-Study-with-SAP-12.jpg)
13. Complete Test Scheduling: QM02
Click on Complete Test Scheduling>> Choose Yes
![Pharmaceutical Stability Study with SAP 13](https://thangtv.net/wp-content/uploads/2021/01/Pharmaceutical-Stability-Study-with-SAP-13.jpg)
14. Define Start Date of Study: QM02
Click on Define Start Date of Study. Enter the date and click on Save And Change Notification.
![Pharmaceutical Stability Study with SAP 14](https://thangtv.net/wp-content/uploads/2021/01/Pharmaceutical-Stability-Study-with-SAP-14.jpg)
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
![Pharmaceutical Stability Study with SAP 16](https://thangtv.net/wp-content/uploads/2021/01/Pharmaceutical-Stability-Study-with-SAP-16.jpg)
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
![Pharmaceutical Stability Study with SAP 16](https://thangtv.net/wp-content/uploads/2021/01/Pharmaceutical-Stability-Study-with-SAP-16.jpg)
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
![Pharmaceutical Stability Study with SAP 17](https://thangtv.net/wp-content/uploads/2021/01/Pharmaceutical-Stability-Study-with-SAP-17.jpg)
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.
![Pharmaceutical Stability Study with SAP 19 step 2](https://thangtv.net/wp-content/uploads/2021/01/Pharmaceutical-Stability-Study-with-SAP-19-step-2.jpg)
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
![Pharmaceutical Stability Study with SAP 20 1](https://thangtv.net/wp-content/uploads/2021/01/Pharmaceutical-Stability-Study-with-SAP-20-1.jpg)
After study completed, the Action box would be like that:
![Pharmaceutical Stability Study with SAP 20 2](https://thangtv.net/wp-content/uploads/2021/01/Pharmaceutical-Stability-Study-with-SAP-20-2.jpg)
Guidance on Pharmaceutical Stability Study with SAP S/4HANA Part 1/2
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