Quality & Compliance
Quality, Compliance and Control Across the Manufacturing Lifecycle
Cyclotek’s manufacturing operations are supported by our TGA licensed Quality Management System, validated processes and ongoing quality oversight.
Radiopharmaceutical manufacturing requires discipline at every stage. Cyclotek’s quality management system supports consistent production in accordance with applicable regulatory requirements.
From synthesis and quality control testing through to batch release and distribution, every product is managed through defined procedures, documented controls and independent quality review before clinical supply.
Regulatory Compliance
Operations are licensed and governed under applicable Australian and New Zealand regulatory frameworks, with oversight from relevant health authorities.
GMP-Controlled Manufacturing
Manufacturing activities are conducted through controlled processes designed to support quality, consistency and compliance.
Quality Assurance & Batch Release
Each product is subject to defined testing, documentation and quality review before release for clinical distribution.
Qualification & Validation
Validated Systems and Production Methods
Cyclotek applies formal qualification and validation processes to confirm that equipment, processes and control systems perform as intended before routine production. Ongoing monitoring, periodic review and revalidation help ensure continued performance following system changes, upgrades or evolving regulatory requirements.
Traceability & Record Control
Traceability, Documentation and Record Control
Cyclotek’s manufacturing operations are supported by robust documentation and traceability systems. Batch records, test results, quality approval, and manufacturing documentation are maintained to support regulatory compliance, audit readiness and complete product traceability across the network.
