Aligned with national and international standards, Luina Bio’s total quality management system ensures that quality is embedded in their processes, products and services
As one of Australia’s most experienced CDMOs, Luina Bio offers a range of services including the production of cGMP material for preclinical studies and clinical trial material batches for Phase 1, 2 and 3 clinical studies. The company has actively invested in the resources and technologies necessary for ensuring that it is not only up to date but that it is “top-of-the-line.”
Based in Brisbane, Luina Bio’s manufacturing follows international cGMP guidelines set out in the Pharmaceutical Inspection Co-operation Scheme’s Guide to Good Manufacturing Practice for Medicinal Products Part II (PIC/S 009-8). The facility holds an Australian Therapeutic Goods Administration (TGA) license and is routinely audited by the TGA and the company’s clients as part of its due diligence and regulatory compliance.
The TGA license also demonstrates that the company follows the International Conference on Harmonisation (ICH) Technical Requirements for the Registration of Pharmaceuticals for Human Use and is recognized by other PIC/S member countries.
In alignment with TGA ICH guidelines, the critical elements of quality management principles are:
- Quality should be the responsibility of all persons involved in manufacturing.
- Each manufacturer should establish, document, and implement an effective system for managing quality that involves the active participation of management and appropriate manufacturing personnel.
- The system for managing quality should encompass the organisational structure, procedures, processes and resources, as well as activities necessary to ensure confidence that the API will meet its intended specifications for quality and purity. All quality-related activities should be defined and documented.
- There should be a quality unit(s) that is independent of production and that fulfills both quality assurance (QA) and quality control (QC) This can be in the form of separate QA and QC units or a single individual or group, depending upon the size and structure of the organization.
- The persons authorised to release intermediates and active pharmaceutical ingredients (APIs) should be specified.
- All quality-related activities should be recorded at the time they are performed
- Any deviation from established procedures should be documented and explained. Critical deviations should be investigated, and the investigation and its conclusions should be documented
- No materials should be released or used before the satisfactory completion of evaluation by the quality unit(s) unless there are appropriate systems in place to allow for such use (e.g. release under quarantine as described in Section 10.20 or the use of raw materials or intermediates pending completion of evaluation)
- Procedures should exist for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g. quality related complaints, recalls, regulatory actions, etc.)
In addition to a TGA license for the manufacture of human therapeutic APIs from biological and synthetic sources, the Luina Bio facility operates under the following licenses:
- Australian Pesticides and Veterinary Medicines Authority (the veterinary equivalent of the TGA) license for the manufacture of sterile immunobiological products
- Office of the Gene Technology Regulator license for the production of products from genetically modified organisms
- Australian Quarantine and Inspection Service license for import and use of biologic materials
Luina Bio prides itself on providing a quality manufacturing service. It operates under a total quality assurance system in alignment with the above national and international standards, providing clients with the assurance that their products are being manufactured under the most appropriate conditions, using the most up to date equipment and practices.