Qualification Fill and Finish
This project involved the full GMP qualification of a complete fill and finish process line, including upstream preparation, aseptic filling, and final container closure. The objective was to commission and qualify the system for clinical and commercial production of sterile drug products.
QPS Engineering managed the entire project lifecycle from FAT/SAT coordination through to IQ, OQ, and PQ execution on-site. The scope covered vial washing tunnels, sterilization tunnels, filling machines, isolator systems, and capping stations. Particular focus was placed on achieving contamination control, cleanroom integration, and operator protection.
Our team developed all required qualification documentation based on client-specific SOPs and GAMP 5 principles, including risk assessments, test protocols, and final reports. We supported media fills, alarm testing, and ensured traceability of critical parameters across the full process.
Scope of Services
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FAT/SAT witnessing and documentation review
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Installation Qualification (IQ) of all fill-finish equipment
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Operational Qualification (OQ) with challenge tests and alarm simulations
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Performance Qualification (PQ) with process simulation (media fills)
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Integration of environmental monitoring and cleanroom classification
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GMP documentation package including risk-based traceability matrix
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Regulatory inspection support
