Hospira Healthcare India Pvt. Ltd.

A Pfizer Company
Visakhapatnam, A.P., India.

Agile Manufacturing Production System (AMPS) Business Verification Script

Name of script AMPS Scripts Negative Scenarios

Objective To verify AMPS solution for Negative Scenarios

Scope This Business Verification script is appllicable only for Negative Scenarios

1. Check the recipes required for the execution of the negative scenarios are approved.
2. Ensure the required work stations and work centers are created
Pre Requisites
3. Ensure the batches required for the execution of the scripts are released.
4. Check the master date required for the execution of negative scenarios is created

Executing Team
(Name & Department)

Result
Step # Scenarios AMPS Description / Action AMPS Expected Results Function area Signature
(Pass/Fail)

1.Recording the Pre FIT completion time in the EBR
2 Recording the end of filtration time or filter removal time in the EBR.
1 Crossing of Product and filter hold times 3.Clauclation of actual hold time of the filter
4.Verification of calculated hold time against the set hold time for the filter
exeception if the calculated hold time crosses the valid hold time
1.Pre FIT completion time to be recorded in the EBR
2 End of filtration time or filter removal time to be recorded in the EBR.
3.Actual hold time of the filter to be caluclated
5.Triggering of 4.Calculated hold time to be verified against the set hold time for the filter.
5.Triggering of exeception if the calculated hold time crosses the valid hold time

1.Execution of the batch as per the instructions in the EBR

2.Recording of the values requried to trigger the yield and reconcilaition. 1.Batch to be executed as per the instructions in the EBR.
3.Caluclation of the yield and accountability and verification of the actual value against the limit 2.Entries required to trigeer the yield and reconciliation to be recorded.
2 Yield and reconciliation out of limit
4.Triggering an exception if the calculated 3.Yield and accounatbility to be calculated by the system and should be verified against the limit .
value crosses the limit 4. Exception to be triggered if the calculated value cross the limit.

1. Changing of equipment status to out of service /Cleaning to be required 1. Equipment status to be changed to out of service /Cleaning.
2. Binding of equipment number by scanning the barcode 2. Equipment to be binded by scanning the barcode of the equipment
3 Binding of room and equipment's when their status is not fit for use 3. Verification of the equipment status during binding 3. Equipment status ot be verified during binding
4. Equipment not allowed to bind for the batch 4. System should trigeers the message with current status of the selected equipment and does not
allow to bind.

4 Verification of Sub lot number for all the pallets of a load during the visual Inspection check in
1. Sublot number of Pallet of load to be scanned as reference in the visual inspection check in.
1.Scan the sublot number of one pallet of a load as reference in visual Inspection
2. Sub lot number of the pallet of another load to be scanned
2.Scan the Sublot number of pallet of the another load
3. System should verify the scanned sublot number of pallet of another load and should not allow
3. Verification of the sublot number of the another load against the reference sublot number.
the check in of the pallet.

1.AMPS recipe status in the edit or in verification. 1 AMPS recipe status to be edit or in verification
5 Process order release in SAP with out the approval of the recipe in AMPS 2.Process order created and released in SAP 2. Process order to be created and released in SAP
3.Verification of the status of the recipe in AMPS and process order not released 3. System should check the status of AMPS recipe and SAP process order should not be relelased

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