Product Transfer of different Filling Line
This project involved the successful GMP-compliant transfer of pharmaceutical products between two distinct aseptic filling lines. The objective was to ensure process consistency, product integrity, and regulatory compliance while adapting to different technical setups and machine configurations.
QPS Engineering led the full lifecycle of the product transfer, from feasibility analysis and risk assessment to the execution of media fills and performance qualification (PQ). A detailed comparability study was conducted to validate that critical quality attributes remained unaffected by the line change.
Scope of Services:
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Risk-based feasibility study and gap analysis between both lines
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Execution of validation protocols including media fills and process simulations
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Definition and adjustment of format parts and process parameters
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Documentation support for change control and regulatory readiness
