Quality in Contract Custom Biomanufacturing

Quality in Contract Biomanufacturing

Luina Bio services are bound by our team’s commitment to offering the best solution for the client. Our team finds innovative ways of solving problems. We do this by utilizing our extensive experience in development of cGMP manufacturing process and subsequent production.

Luina Bio takes pride in providing a quality manufacturing service to an international standard. Luina Bio has a total quality assurance system developed and inspected in accordance with local and international requirements.

The Luina Bio facility follows the international GMP guidelines as set out in the (PIC/S) “Guide to Good Manufacturing Practice for Medicinal Products Part II (PIC/S 009-8). Australia is also a founding member state of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) resulting in Australian Therapeutics Goods Administration (TGA) guidelines being adopted internationally. As such our TGA license indicated that we follow the International Conference on Harmonisation (ICH) Technical Requirements for the Registration of Pharmaceuticals for Human Use and our TGA license is recognized by other PIC/S member countries. Also our facility is audited routinely by the TGA and by our clients as part of their due diligence and regulatory compliance.

Besides a license from the TGA for the manufacture of human therapeutic API’s (active pharmaceutical ingredients) from biological and synthetic sources, the LuinaBio  facility also has the following licences:

  • APVMA (Veterinary equivalent of the TGA) licence for manufacture of sterile immunobiological products.
  • OGTR licence for the production of products from genetically modified organisms.
  • AQIS facility licence for import and use of biologic materials.

According to the TGA (Australia’s Therapeutic Goods Administration) and ICH Guidelines, key 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 fulfils 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 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.).

With the above guidelines and internationally recognized licenses in place, Luina Bio offers our clients the confidence that their product is being manufactured under the most appropriate conditions. You can also be assured that Luina Bio offers the most up to date practices because our scientist not only get the job done but also show initiative such as offering suggestions for improving processes.

Luina Bio’s quality unit is staffed with individuals that also understand processes. We therefore are capable of identifying critical quality parameters (CPPs) and key performance indicators (KPIs), and employ real-time monitoring and controls across the manufacturing process.

Contact Us

Email: enquiries@luinabio.com.au
Website: http://www.luinabio.com.au/

 

Tags:
Categories: Quality

Leave a comment