Manufacturing principles
36 Manufacturing principles
The Minister may, from time to time, determine written principles to be observed in the manufacture of therapeutic goods for use in humans.
The manufacturing principles may relate to:
the standards to be maintained, and the equipment to be used, at premises used for the manufacturing of therapeutic goods for use in humans; or
procedures for quality assurance and quality control to be employed in the manufacturing of therapeutic goods for use in humans; or
the qualifications and experience required of persons employed in the manufacture of therapeutic goods for use in humans; or
the manufacturing practices to be employed in the manufacturing of therapeutic goods for use in humans; or
other matters relevant to the quality, safety and efficacy of therapeutic goods for use in humans that are manufactured in Australia;
and may include codes of good manufacturing practice.
Manufacturing principles are legislative instruments.
Despite subsection 14(2) of the Legislation Act 2003, the manufacturing principles may make provision in relation to a matter by applying, adopting or incorporating, with or without modification, any matter contained in an instrument or other writing as in force or existing from time to time.
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