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.
Selborne applies the principles of cGMP to all manufacturing activities as defined in the ICH Q7 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. 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 and internal and external auditing. QA also has responsibility and authority for the release or rejection of intermediate and finished product and raw materials and components for use in manufacturing.
QA monitors all aspects of the Quality System to ensure that activities are conducted in accordance with standards specified in cGMP codes of practice.
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.
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.
Collection abattoirs are subject to government controls that include anti and post mortem veterinary inspections of all animals. The regulation of abattoirs is tightly controlled and subject to routine inspections by external audit.
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.