Document ID: chunk:federal_register_of_legislation:F2024C00464:reg:4:p1
Version: federal_register_of_legislation:F2024C00464
Segment Type: reg
Provision Reference: reg 4 (pt 1/2)
Character Range: 3083–6170

4  Definitions
Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:
(a) biological;
(b) licence;
(c) manufacture;
(d) manufacturing principles;
(e) medicine;
(f) standard; and
(g) therapeutic goods.
  In this instrument:
Act means the Therapeutic Goods Act 1989.
active pharmaceutical ingredient means any substance or mixture of substances intended to be used in the manufacture of a medicine and that, when used in the manufacture of a medicine, becomes an active ingredient of that medicine.
Note: An active pharmaceutical ingredient is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.
Australian Code of Good Manufacturing Practice means the Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products (Version 1.0, April 2013) published by the Therapeutic Goods Administration, as in force or existing at the commencement of this instrument.
Note: The Australian Code of Good Manufacturing Practice is published on the TGA website at www.tga.gov.au.
blood means whole blood collected from a single human donor and processed either for transfusion or further manufacturing.
blood components means any of the following therapeutic components of blood that can be prepared by centrifugation, filtration or freezing using conventional methodologies in blood establishment:
 (a) red cells;
 (b) white cells;
 (c) platelets;
 (d) plasma;
but does not include haematopoietic progenitor cells.
haematopoietic progenitor cells means self-renewing or multi-potent stem cells, or both, capable of maturation into haematopoietic lineages, lineage-restricted pluri-potent progenitor cells, or committed progenitor cells.
PIC/S means the Pharmaceutical Inspection Co-operation Scheme established in 1995 as an extension to the Pharmaceutical Inspection Convention.
  PIC/S Guide to GMP means the document titled Guide to Good Manufacturing Practice for Medicinal Products (PE 009-16, 1 February 2022) published by PIC/S, as in force or existing at 3 June 2024, and includes the Annexes to that document other than the following:
 (a) Annex 4 (Manufacture of veterinary medicinal products other than immunologicals);
 (b) Annex 5 (Manufacture of immunological veterinary medical products);
 (c) Annex 14 (Manufacture of medicinal products derived from human blood or plasma).
plasma means plasma, separated from human donor blood, intended for a number of purposes including the manufacture of further blood components, the manufacture of which is required to be licensed under Part 3-3 of the Act.
PMF Guideline means the Guideline on the Scientific Data Requirements for a Plasma Master File (PMF) Revision 1 (2006) (EMEA/CHMP/BWP/3794/03 Rev. 1) published by the European Medicines Agency, as in force or existing at the commencement of this instrument.
Note: The PMF Guideline is published on the European