Quality Assurance

The Quality Assurance department at LuinaBio provides and maintains the GMP quality system within LuinaBio and supports all aspects of the GMP biopharmaceutical manufacture to ensure the products meet the highest quality standard and regulatory compliance requirements.

We operate under and comply with the PIC/S GMP code in all aspects of our manufacturing, materials, storage, packaging, labelling, testing and distribution. Our written procedures outline the responsibilities of management and the quality unit in relation to our APIs and medicinal products and we regularly perform self-inspections to ensure continued adhered to the highest quality standard.

At LuinaBio, we are committed to our clients’ success, so it is our mission to help your product reach its full potential with the highest possible quality. LuinaBio has a long and a very successful track record in inspections of its biopharmaceutical production facilities by its clients and different regulatory authorities.

Our quality systems have been audited and certified by the Therapeutic Goods Association (TGA), as well as our clients’ global audit teams. Additionally, independent consultants have audited LuinaBio to USFDA requirements. We have a TGA license for the manufacture of human therapeutic API’s from biological and synthetic sources, and an APVMA license for the manufacture of sterile immunobiological products. LuinaBio is also licensed for the production of products originating from genetically modified organisms from OGTR, and for the import and use of biologic materials from DAF (formerly AQIS).

Along with the highest in manufacturing support and development, LuinaBio provides superior document systems control, raw material release, batch release, validated utilities and equipment and continually monitored facility and equipment for assurance that our systems are in control at all times.


Operating as a CMO demands constant evaluation of our quality systems. To meet the high quality standards required LuinaBio’s Quality Assurance department works closely with LuinaBio’s internal organization and our clients to ensure that each project meets full regulatory compliance. LuinaBio is committed to continuous quality improvements and our goal is to provide biopharmaceutical products to our customers that meet the highest safety and quality standards.


Our experienced quality staff also understands the processes that make our business operate and can identify the critical quality parameters and key performance indicators needed to monitor all aspects of your project. We employ real-time monitoring and controls so you have the confidence that your product is meeting the required standards at all times.