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Radiopharma Expansion Commissioning Support

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Advent Drives Radiopharma’s Efficiency Through Commissioning and Qualification Support

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Life SciencesLife Sciences

Industry

Pharma Manufacturing

Location

Canada

Advent Engineering is managing Commissioning and Qualification (C&Q) for a greenfield radiopharmaceutical facility, ensuring regulatory compliance while driving efficiencies in the quality program and phased GMP production.

Challenge

A radiopharmaceutical facility planned a 72,000 sq ft greenfield expansion with 10x increased capacity. The aggressive, phased timeline required on-time GMP production while ensuring full compliance.

Solutions

Advent Engineering handled full building C&Q, providing testing, documentation, and integration with the client’s quality program. The team applied risk-based strategies and ongoing monitoring to streamline processes and maintain project schedule and deliverables.

Services Performed

Advent Engineering provided comprehensive Commissioning and Qualification support, including full building testing, compliance documentation, and integration with the client’s quality program. The team applied risk-based strategies, monitored project progress, and optimized systems to ensure phased GMP production remained on schedule and compliant with regulatory requirements.

Results

The project has improved efficiencies in documentation and quality practices. Risk-based C&Q planning ensures phased releases remain compliant, supporting timely GMP production.