Contents
- Part 1—Preliminary
- Part 2—Manufacturing principles
- 6 Manufacturing principles—therapeutic goods other than blood, blood components, haematopoietic progenitor cells etc.
- 7 Manufacturing principles—therapeutic goods that are blood, blood components, haematopoietic progenitor cells and biologicals that do not contain live animal cells, tissues or organs
- Part 3—Application
- Schedule 1—Manufacturing Principles
Part 1—Preliminary
3 Authority#
This instrument is made under section 36 of the Therapeutic Goods Act 1989.
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:
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 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.
(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.
relevant officer means an officer of the Therapeutic Goods Administration.
Therapeutic Goods Administration or TGA means that part of the Department known as the Therapeutic Goods Administration.
Part 2—Manufacturing principles
6 Manufacturing principles—therapeutic goods other than blood, blood components, haematopoietic progenitor cells etc.#
The manufacturing principles in Part 1 of Schedule 1 are to be observed in the manufacture of therapeutic goods, including active pharmaceutical ingredients and sunscreens, for use in humans, other than the therapeutic goods specified in paragraphs 7(a) to (d).
7 Manufacturing principles—therapeutic goods that are blood, blood components, haematopoietic progenitor cells and biologicals that do not contain live animal cells, tissues or organs#
The manufacturing principles in Part 2 of Schedule 1 are to be observed in the manufacture of the following therapeutic goods for use in humans:
(a)biologicals that do not comprise or contain:
(i)live animal cells; or
(ii)live animal tissues; or
(iii)live animal organs;
(b)blood;
(c)blood components;
Note 1: The manufacturing principles to be observed in the manufacture of biologicals that comprise or contain live animal cells, tissues or organs are those set out in Part 1 of Schedule 1 (and not those set out in Part 2 of Schedule 1).
Note 2: Plasma is a blood component, see section 4 for definitions of blood components and plasma.
Part 3—Application
8 Application#
(1)In this section:
amending determination means the Therapeutic Goods (Manufacturing Principles) Amendment (PIC/S Guide) Determination 2025.
sterile therapeutic goods means therapeutic goods that are:
(a)sterile medicines; or
(b)sterile active pharmaceutical ingredients.
(2)The amendment of this instrument made by item 1 in Schedule 1 to the amending determination applies to the manufacture of therapeutic goods that occurs on or after 1 September 2025.
(3)Despite subsection (2), the amendment of this instrument made by item 1 in Schedule 1 to the amending determination, only to the extent that the amendment has the effect of incorporating clauses 2.1, 2.3, 7.14 and 9.31 of Annex 1 to the PIC/S Guide to GMP, applies to the manufacture of sterile therapeutic goods that occurs on or after 1 March 2026.
Schedule 1—Manufacturing Principles
Note: See sections 6 and 7.
Part 1—Therapeutic goods other than blood, blood components, haematopoietic progenitor cells etc.
(1) The manufacture of therapeutic goods to which this Part applies must comply with applicable procedures and requirements in the PIC/S Guide to GMP.
(a) the manufacturer demonstrates, to the satisfaction of a relevant officer, that the failure to adopt that procedure or requirement:
(i) will not increase the risk that the therapeutic goods manufactured will, or could, cause harm or injury to any person, or will, or could, potentially have the effect of causing or contributing to such harm or injury; and
(ii) will not increase the risk of those therapeutic goods failing to comply with an applicable standard or relevant condition of registration, listing or inclusion; and
(iii) will not depart from any applicable record keeping requirements contained in the PIC/S Guide to GMP; or
(b) where an alternative to the procedure or requirement set out in the PIC/S Guide to GMP has been adopted—the manufacturer demonstrates, to the satisfaction of a relevant officer, that:
(i) the alternative will not increase the risk that the therapeutic goods manufactured will, or could, cause harm or injury to any person or will, or could, potentially have the effect of causing or contributing to such harm or injury; and
(ii) the alternative will not increase the risk of those therapeutic goods failing to comply with an applicable standard or relevant condition of registration, listing or inclusion; and
(iii) will not depart from any applicable record keeping requirements contained in the PIC/S Guide to GMP.
(3) The reference to “applicable procedures and requirements” in subsection (1) does not include a procedure or requirement specified in an Annex to the PIC/S Guide to GMP that is identified as voluntary.
Part 2—Therapeutic goods that are blood, blood components, haematopoietic progenitor cells and biologicals that do not contain live animal cells, tissues or organs
(1) The manufacture of therapeutic goods to which this Part applies must comply with applicable procedures and requirements in the Australian Code of Good Manufacturing Practice.
(2) Where the Australian Code of Good Manufacturing Practice provides that a procedure or requirement ‘should’ be followed, the manufacture of therapeutic goods in Australia must follow the procedure or requirement in order to comply with the Australian Code of Good Manufacturing Practice.
(6) The failure of a manufacturer of therapeutic goods to which this Part applies, to follow an applicable procedure or requirement set out in the Australian Code of Good Manufacturing Practice will constitute a failure to comply with the Australian Code of Good Manufacturing Practice unless, in relation to that particular procedure or requirement:
(a) the manufacturer demonstrates, to the satisfaction of a relevant officer, that the failure to adopt that procedure or requirement:
(i) will not increase the risk that the therapeutic goods manufactured will, or could, cause harm or injury to any person, or will, or could, potentially have the effect of causing or contributing to such harm or injury; and
(ii) will not increase the risk of those therapeutic goods failing to comply with an applicable standard or relevant condition of registration or inclusion; and
(iii) will not depart from any applicable record keeping requirements contained in the Australian Code of Good Manufacturing Practice; or
(b) where an alternative to the procedure or requirement set out in the Australian Code of Good Manufacturing Practice has been adopted—the manufacturer demonstrates, to the satisfaction of a relevant officer, that:
(i) the alternative will not increase the risk that the therapeutic goods manufactured will, or could, cause harm or injury to any person, or will, or could, potentially have the effect of causing or contributing to such harm or injury; and
(ii) the alternative will not increase the risk of those therapeutic goods failing to comply with an applicable standard or relevant condition of registration or inclusion; and
(iii) will not depart from any applicable record keeping requirements contained in the Australian Code of Good Manufacturing Practice.
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