In a pharmaceutical facility, a seemingly small automation change can affect a larger qualified system.
A revised PLC sequence, new SCADA interface, changed alarm limit, or additional EMS sensor may influence functions that have already been tested and approved. The challenge is not simply to confirm that the new function works. It is to determine whether related functions and GMP records remain reliable.
- Identify the Change Boundary
Document the modified component and its connections to existing systems. Consider control logic, alarms, interlocks, user access, data transfers, and affected equipment.
- Assess the GMP Impact
Determine which functions could affect product quality, process control, environmental conditions, or GMP records. Use the documented risk assessment to define the testing scope.
- Test Changed and Related Functions
Testing may include:
Functional testing of modified logic
Alarm and interlock challenges
Regression testing of related functions
Verification of data transfers where relevant
Review of configuration backups and access controls where applicable
The exact tests should follow the change assessment and approved site procedures.
- Maintain Controlled Records
Retain the approved change record, configuration documentation, test evidence, deviations, and final reports. Update relevant specifications and procedures before the modified system is released for GMP use.
EU GMP Annex 11 addresses computerised systems, while Annex 15 provides relevant expectations for qualification, validation, and change control. GAMP 5 supports a risk-based approach but does not replace applicable regulations.
The key lesson: test the impact of the change, not only the component that changed.
Read more: https://incepbio.com/blog/brownfield-cqv/
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