Quality Assurance and Quality Control (QA/QC)
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 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
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
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.
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
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
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.
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
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.