Labelling, Packaging, Distribution and Warehousing
Manufacturing in a cGMP compliant manner is only one aspect of the services LuinaBio provides to clients. Maintaining compliance throughout the lifecycle of a product, from receipt of the raw materials to final distribution, is also handled as per regulatory standards.
LuinaBio provides investigational product manufacturing, labelling, packaging, warehousing and distribution services for companies and research institutes undertaking clinical trials.
Our staff can assist with the review and preparation of labels and ancillary labels that comply with APVMA, TGA and MEDSAFE requirements. We have an on-site labelling machine and printer capable of multilingual labeling, re-labeling, over-labelling and shelf life extensions under cGMP standards.
Our GMP and GCP manufacturing and warehousing facilities in Queensland manufacture, warehouse and distribute clinical supplies for use in Australia and New Zealand.
Our temperature controlled storage facilities are validated and monitored 24/7 and include:
• Temperature controlled warehouse at 22˚C ± 2˚C
• Refrigerated warehouse at 2˚C-8˚C
• Freezers (-20˚C, -80 ˚C)
Our warehouse allows for a dedicated and secure quarantine area of clinical trial supplies while awaiting local ethics approvals and enables faster distribution to clinical sites locally, interstate and internationally (NZ) for trial start-up.
We can manage distribution in Australia and New Zealand through a network of high quality carriers and QP release for supply to Europe. Our mutual qualification with ABF (www.abf-pharma.com) allows for expedited import/export from/to EU/US for API and finished products with established relevant permits (DAF, Restricted Substances, Controlled substances, etc.)
Our services include a range of permit applications (DAF, Drugs of Addiction etc.) and review of stability data, temperature logs and certificates of analysis prior release of product or on receipt of overseas shipments. We have established recall procedures for traceability and accountability even after products leave our facility.