Regulatory, ethical and legal issues in biotechnology Semester 2 2012 ChemTech Case study (Draft) Development of an avian flu vaccine for the Australian poultry industry The company ChemTech is a...

A report on the regulatory requirements for the establishment of an influenza vaccine.
Abstract
Regulatory requirements associated with the project of development of recombinant
vaccines for the treatment of respiratory diseases in intensively reared pigs and poultry. The
company’s first project being the development of a recombinant flu vaccine to treat avian
influenza A (AIA) for the poultry industry in Australia requires that all regulations are adhered
to. The company intends to develop the recombinant vaccine in house and outsource vaccine
manufacture to Bioproperties Pty Ltd and field testing in a commercial hatchery Baiada Poultry
under a collaborative research agreement with the Poultry Cooperative Research Centre Poultry
Hub.
A number of standards regulate the operations of laboratories throughout the world to
standardize practices and ensure optimum utilization of resources. Laboratories are required to
provide quality services to their customers while at the same time expected to avoid conflict of
interest. The technical knowledge of the personnel is a requirement and documentation of all
plans and activities is a necessary aspect.
1. Introduction
A number of regulations and standards exist that regulate the activities of laboratories and
therefore these should be adhered to. According to Australian Standard 2005, a laboratory can be
held liable in law and therefore should carry out its calibration and testing activities in
accordance to the international standards. Management system covers all the work that is carried
out in the laboratory and in order to avoid conflict of interest, the activities of personnel should
be clearly defined. The laboratory should have technical as well as managerial personnel who
have the authority and resources to carry out their duties. The laboratory personnel and
management should be free from internal or external pressures both financial and economic that
may have an impact on the results.
The laboratory should protect its customers through policies and procedures. Clearly
define the management structure and organization of the laboratory. The responsibility,
interrelationship and authority of the personnel should be clearly specified. Provide supervision
of calibration staff by a qualified person. Have a technical management with the responsibility of
technical operations. The laboratory should appoint a member of staff into the position of quality
manager and appoint assistants to management. The personnel should be made aware of the
importance and relevance of their activities (Australian Standard 2005).
According to the Australian standard 2005, a laboratory should have a management
system that is appropriate to the scope of activities it undertakes. The policies for the
management system relates to the quality such as quality policy statement. The laboratory shall
have established and maintained procedures that control all documents forming part of the
management system. It is the responsibility of the laboratory to maintain procedures for
reviewing requests contracts and tenders.
Methods to be used for tenders and contracts are documented, understood and define.
The laboratory should also have the resources in order to meet its requirements. Subcontracted
work should be kept with a subcontractor that is competent meaning they must comply with the
international standards. Any subcontracted work should be informed to the customers and
laboratory is responsible for the works of the subcontractor and shall maintain a list of all the
subcontractors.
The Organization for Economic Co-operation and Development (OECD) is an
intergovernmental body that is composed of 29 nations from the industrialized countries in
Europe, North America and the pacific. The members meet to harmonize, coordinate and discuss
issues that are of mutual concern while working together in response to international problems.
The works are carried out by more than two hundred committees that are specialized and
subsidiary groups that are composed of delegates from member countries (OECD series on
principles of good laboratory practice and Compliance monitoring 2007).
The organization is responsible for ensuring chemical safety practiced in the safety
division and environmental health. Safety division and the environmental health periodically
publishes documents that are free of charge in six different series principles of good laboratory
practices and compliance monitoring, testing and assessment, risk management, pesticides,
harmonization of regulatory oversight in biotechnology and chemical accidents (OECD series on
principles of good laboratory practice and Compliance monitoring 2007).
In order to counter schemes of implementation which are different and could cause an
impediment to global trade in chemical, the organization members have pursued good laboratory
practices and test methods that are internationally harmonized. Principles of good laboratory
practices were adopted by the organization in the year 1981. A new expert group was formed in
the years 1995 and 1996 with the mandate of revising and updating the principles (OECD series
on principles of good laboratory practice and Compliance monitoring 2007).
The principles of good laboratory practices have their main purpose being the promotion
of development in quality test data. Test data that is comparable forms the basis for mutually
accepting data among countries. Reliance of test data developed in foreign countries confidently
will reduce chances of duplicating tests and save time and resources. Application of the
principles helps in the creation of technical barriers that hamper trade therefore improving the
protection of the environment and human health (OECD series on principles of good laboratory
practice and Compliance monitoring 2007).
The principles of good laboratory practice are applicable to non clinical safety testing for
test items that are contained in pesticides, veterinary drugs, pharmaceutical products, pesticides,
food additives, industrial chemicals and feed additives. The...