Our Quality Management System
At Smart MCs, quality is embedded into every stage of our operations. We have established a traceable, risk-based Quality Management System designed to support consistent manufacturing of microcarriers for use in regulated cell culture and biomanufacturing environments.
- Commitment to consistent, high-quality product manufacturing and service provided
- Focus on reproducibility, traceability, and risk-based quality controls
- Products designed to support use in regulated cell culture environments including animal & human vaccine, stem cell, viral vector and cultured meat biomanufacturing.
- ISO9001:2015 Certified
- GMP Compliant as Ancillary product
- State-of-the-art Manufacturing Plant Under ISO7 Cleanrooms
Smart MCs Microcarriers are produced under a quality system certified under ISO9001:2015 as a provider of ancillary materials and components for cell-based biomanufacturing, ensuring lot-to-lot consistency and traceability throughout the manufacturing process.
- Certified to ISO 9001 Quality Management System standards
- Quality processes audited and maintained through regular reviews
- Continuous monitoring of quality performance and improvement actions
- Ongoing monitoring of quality performance and key quality metrics
- Corrective and preventive actions implemented to drive continual improvement
- Customer feedback incorporated into process and product enhancements
- Quality systems and manufacturing controls aligned with GMP expectations
- Manufactured as GMP-compatible ancillary materials in line with USP <1043> expectations for cell, gene, and tissue-engineered products
- End-to-end traceability maintained for raw materials and approved suppliers, supported by documented qualification processes and trained personnel operating under controlled quality procedures
- Processes designed to support use in regulated cell culture environments including animal & human vaccine, stem cell, viral vector and cultured meat biomanufacturing.
- Products supplied for research, process development, and manufacturing workflows
- Each production batch assessed against predefined specifications and acceptance criteria prior to release
- Formal batch review and documented release completed before distribution
- Testing performed and a Certificate of Analysis can is provided for each batch, including assessment of endotoxin levels, bioburden or sterility, pathogen risk, and material safety or toxicity, as applicable
- Manufacturing operations based in Sydney, Australia
- Manufacturing conducted within an ISO Class 7 cleanroom designed to control particulate and contamination risk
- Support provided for customer quality assessments and supplier questionnaires
- Customer audits supported under mutual confidentiality agreements
- Dedicated quality and technical support available to address customer requirements