QA/QC

Quality Policy
It is Selborne's policy to manufacture and supply products that meet or exceed customer expectations in terms of quality and compliance with pertinent regulatory requirements. The Management of the Company is committed to achieving this policy by establishing and maintaining the highest applicable standards of quality in our people, facilities, processes and services. A culture of continuous improvement is to be encouraged among all staff and facilitated through managed control of change.

Quality Systems
Selborne applies the principles of cGMP to all manufacturing activities as defined in the ICH Q7A guidelines (International Conference on Harmonisation - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) and other National/International codes as may be relevant.

To maintain compliance with cGMP and regulatory requirements, Selborne maintains an independent QA/QC department with the following responsibilities:

Quality Control (QC) is responsible for the testing of raw materials, components, intermediates and finished products. QC also has responsibility and authority for the release or rejection of raw materials and components for use in manufacturing. The environmental monitoring program in the production facility is conducted and evaluated by QC.

Quality Assurance (QA) has responsibility and authority in all matters relating to quality control, documentation, internal and external auditing and the release or rejection of finished product.

QA monitors all aspects of the Quality System to ensure that activities are conducted in accordance with standards specified in cGMP codes of practice. QA also ensures that products comply with prescribed specifications at all stages of manufacture.

Continuous Improvement
Selborne seeks to continually improve both the quality of its products and the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results (internal and external), analysis of data, corrective and preventive actions and structured review.

Regulatory Licensing
Selborne is licensed by the Australian Therapeutic Goods Administration (TGA) for the manufacture of antisera in large animals for therapeutic applications.

Selborne also has experience in the submission of applications with other regulatory authorities as applicable to the country of end use.

Selborne holds EDQM Certificates of Suitability with respect to TSE safety for all bovine products.

Animal Products Sourcing
Largely fueled by TSE (Transmissible Spongiform Encephalopathy) concerns, the use of animal sourced materials in the production of human therapeutics is becoming increasingly regulated. Consequently, the availability of key components from safe and reliable sources grows proportionately. This is particularly evident in global, pharmaceutical markets. Therefore, it is Selborne's policy that *all products derived from animal sources with TSE concerns (bovine, ovine and caprine), be limited to collection from countries considered to be TSE free, namely Australia and New Zealand.

Selborne sources its starting materials from closed, dedicated donor groups of animals and from licensed and inspected abattoirs only.

Traceability
In Australia, collection abattoirs are subject to Australian government controls that include anti and post mortem veterinary inspections of all animals. The regulation of Australian abattoirs is tightly controlled and subject to routine inspections by external organisations such as the USDA.

Selborne maintains systems that ensure that all products can be traced back through starting materials to abattoir and date of collection and from there, back to the animals' farm(s) of origin.

Donor Animals
The use of animals for production purposes and associated husbandry issues are carried out in accordance with established animal welfare guidelines.

Donor animals to be used in production are purchased from approved suppliers to provide a traceable history and certify health and vaccination status. Prior to admission to any donor program, all animals are subject to an appropriate quarantine period.

Animals are individually identified with established procedures in place for the routine monitoring of their health, the adequacy of feed and water supplies, and preventative health maintenance treatments. These procedures include the proper handling of sick or dead animals with appropriate hospital and quarantine measures, observation of withholding periods, post mortem requirements and a "look-back" system to establish possible impact on product. Issues relating to animal health, veterinary treatments and paddock inspections are recorded and kept on file.