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ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE
1.1 Risk assessment for Audit trail review definition for Weighing and Dispensing step
1) Scenario:
The WMS (warehouse management system) is a component of the company ERP system (enterprise resource planning); it is interfaced with the LIMS
system and with the ERP system. It supports the execution of operations related to the handling of materials used in production, from the receiving of
raw materials to the shipping of finished products
2) Business process mapping
The business process mapping utilizes the 6 FDA systems and their subsystems
➔ FDA Process: Production control system
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ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE
3. Proccess
1. Vendor 4. Material 5. Weigh & 6. Material
2. Raw Material Manufacturing A
Qualification Picking / Staging Dispense Charging
Order
8. Material 11. Batch Record 12. Batch
A 7. Processing 9. Packing 13. Logistics
Discharge Review Releases
10. Inprocess 14. QC Laboratory
Controls Analysis
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ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE
➔ Sub-Processes 4 – Material Picking/staging and 5 - Weigh & Dispense
3) Data (paper/electronic) and system identification
a. System identification: (see section 3 step A)
4.1 4.2 4.3 5.1 5.2 5.3 5.4
Step Lot selection Package selection, Pick-up from Weighing and splitting Stage to Transfer to Material check
pick-list generation shelves and transfer requisition area production
to dispensing rooms department
GxP Data electronic electronic electronic paper/ electronic electronic paper/
electronic electronic
System WMS WMS WMS WMS WMS WMS WMS
Scales
Label printing system
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ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE
b. Data Identification: (see section 3 step B)
Step 4.1 Lot selection 4,2 Package 4.3 Pick-up from 5.1 Weighing and 5.2 Stage to 5.3 Transfer to 5.4 Material check
selection, pick-list shelves and splitting requisition area production
generation transfer to department
dispensing rooms
System 1: WMS
Lot number * Package ID * Material position Net Weigh Material position * Material position Gross weight
elements
GxP Data
Quantity * Tare * Time in temporary Time in temporary Package ID
Package ID storage storage Scale ID
Package labels
System 2: scales
Net Weigh Gross weight
Tare * Package ID
elements
GxP Data
Package ID Scale ID
Scale ID
System 3: printing system
Package labels
elements
GxP Data
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ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE
c. Highlight electronic GxP data that can be modified/deleted or re-processed after creation (see section 3 step C): as indicated by an asterix in
above table.
4) Data and System categorisation
a. Data severity assessment (see section 4.1)
This example will focus on the WMS system only. The scales systems and printing systems should be handled in a separate assessment.
The WMS is used for intermediates and APIs manufacturing.
According to the severity definitions, the API categorization results in very high severity data.
b. System profiling (see section 4.2, decision tree figure 3)
System 1: WMS -> cat 6
System 2: Scales -> cat 4
System 3: Labelling -> cat 4
c. System assessment: (according to checklist 4.3 table 2)
Only the gaps are in below overview.
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5) Risk Assessment (FMEA to calculate the gaps and their current individual Risk Priority Numbers (RPN)) (see section 5)
6) Risk management (see section 6)
The above table shows that 4 of the 5 gaps have a high RPN (Red). Actions have been defined to address these issues immediately.
Additional actions have also been defined to mitigate the other gaps
In the next table the RPNs are recalculated after implementation of the defined actions.
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ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE
To close out the risk in a documented and formal way, an additional column can describe the objective evidence that has been implemented to remediate the gaps.