At Luina Bio, we are committed to helping your products reach their full potential through rigorous clinical quality assurance, quality control, and regulatory documentation.
Our Quality Assurance department provides and maintains the GMP quality management system while supporting all aspects of the GMP biopharmaceutical manufacturing process. This includes ensuring products meet the highest quality standard, meeting regulatory compliance requirements, and maintaining appropriate regulatory documentation. We operate under and comply with the PIC/S GMP code in all aspects of our manufacturing, materials, storage, packaging, labeling, testing, and shipment.
We have a long and successful track record of inspections of our biopharmaceutical production facility by its clients and different regulatory authorities. Our quality management systems have been audited and certified by the Australian Therapeutic Goods Administration (TGA), as well as our clients’ global audit teams. Independent consultants have also audited Luina Bio to U.S. FDA requirements.
We hold a TGA license for the manufacture of human therapeutic drug substances/APIs from biological and synthetic sources and an APVMA license for the manufacture of immunobiological products. Luina Bio is also licensed to produce materials originating from genetically modified organisms from OGTR and for the import and use of biologic materials from DAF (formerly AQIS).
Along with GMP manufacturing and development support, Luina Bio’s Quality Assurance provides superior document control systems, raw material release, batch release, validated utilities and equipment, a continually monitored facility, and equipment for assurance that our systems are always in control.