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Determinations/Health as made
This instrument determines the manufacturing principles to be observed in the manufacture of therapeutic goods for the purposes of section 36 of the Therapeutic Goods Act 1989. It repeals and replaces the Therapeutic Goods (Manufacturing Principles) Determination 2018.
Administered by: Health
Registered 30 Jun 2020

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods (Manufacturing Principles) Determination 2020

I, Tracey Duffy, as delegate of the Minister for Health, make the following determination.

Dated 30 June 2020

Tracey Duffy

First Assistant Secretary

Medical Devices and Product Quality Division

Health Products Regulation Group

Department of Health

 


Contents

Part 1—Preliminary                                                                                                     1

1  Name........................................................................................................................................ 1

2  Commencement........................................................................................................................ 1

3  Authority.................................................................................................................................. 1

4  Definitions................................................................................................................................ 1

5  Repeals..................................................................................................................................... 3

Part 2—Manufacturing principles                                                                              4

6  Manufacturing principles—therapeutic goods other than blood, blood components, haematopoietic progenitor cells etc.  4

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..................................................... 4

Part 3—Transitional                                                                                                     4

8  Definitions................................................................................................................................ 4

9  Transitional............................................................................................................................... 5

Schedule 1—Manufacturing Principles                                                                      6

Part 1—Therapeutic goods other than blood, blood components, haematopoietic progenitor cells etc.                                                                                                                         6

Part 2—Therapeutic goods that are blood, blood components, haematopoietic progenitor cells and biologicals that do not contain live animal cells, tissues or organs              7

Schedule 2—Repeals                                                                                                     9

Therapeutic Goods (Manufacturing Principles) Determination 2018                                          9

 

 


Part 1—Preliminary

1  Name

                   This instrument is the Therapeutic Goods (Manufacturing Principles) Determination 2020.

2  Commencement

             (1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument

The day after this instrument is registered.

 

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

             (2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

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:

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 Guide to Good Manufacturing Practice for Medicinal Products (PE 009-14, 1 July 2018) published by PIC/S, as in force or existing at the commencement of this instrument, 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).

Note:          The PIC/S Guide to GMP is published on the PIC/S website at https://picscheme.org and reproduced on the TGA website at www.tga.gov.au.

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 Medicines Agency website at www.ema.europa.eu.

relevant officer means an officer of the Therapeutic Goods Administration.

technical master file, in relation to the manufacture of therapeutic goods that are blood, blood components or haematopoietic progenitor cells, means:

                     (a)  compilations of scientific and technical data provided by a manufacturer, including a description of the steps of manufacture that is consistent with the TMF Guideline; and

                     (b)  detailed scientific and technical data or information that must satisfy a relevant officer that:

                              (i)  in relation to the manufacture of blood or blood components—the therapeutic goods conform to TGO 102;

                             (ii)  in relation to the manufacture of haematopoietic progenitor cells derived from cord blood—the therapeutic goods conform to TGO 94;

                            (iii)  in relation to the manufacture of blood, blood components, or haematopoietic progenitor cells—the therapeutic goods conform to TGO 88.

TGO 88 means the Therapeutic Goods Order No. 88  Standards for donor selection, testing, and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products.

Note:          TGO 88 is published on the Federal Register of Legislation at www.legislation.gov.au.

TGO 94 means the Therapeutic Goods Order No. 94 (Standard for Haematopoietic Progenitor Cells derived from Cord Blood) 2017.

Note:          TGO 94 is published on the Federal Register of Legislation at www.legislation.gov.au.

TGO 102 means the Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019.

Note:          TGO 102 is published on the Federal Register of Legislation at www.legislation.gov.au.

Therapeutic Goods Administration or TGA means that part of the Department known as the Therapeutic Goods Administration.

TMF Guideline means the Guideline for the Preparation of Technical Master Files for Blood, Blood Components and Haematopoietic Progenitor Cells (Third Edition, 2008), published by the Therapeutic Goods Administration, as in force or existing at the commencement of this instrument.

Note:          The TMF Guideline is published on the TGA website at www.tga.gov.au.

5  Repeals

                   Each instrument that is specified in Schedule 2 is repealed as set out in the applicable items in that Schedule.

Part 2—Manufacturing principles

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;

                     (d)  haematopoietic progenitor cells.

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—Transitional

8  Definitions

                   In this Part:

former instrument means the instrument specified in Schedule 2, as in force immediately before the commencement of this instrument.

Transition Notice means Transition to new GMP requirements for medicinal products (Version 1.0, June 2020), published by the Therapeutic Goods Administration, as in force or existing at the commencement of this instrument.

Note:          The Transition Notice is published on the TGA website at www.tga.gov.au.

transition period means the period beginning on the commencement of this instrument and ending on 30 June 2021, during which the manufacturer must transition to the manufacturing principles determined under this instrument in accordance with the Transition Notice.


 

9  Transitional

                   Despite the repeal of the former instrument made by section 5, the manufacturing principles determined under that instrument may be observed by a manufacturer in relation to the manufacture of therapeutic goods mentioned in section 6 for the transition period.

 


 

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.

             (2)  Where the PIC/S Guide to GMP provides that a procedure or requirement ‘should’ be followed, the manufacture of therapeutic goods must follow the procedure or requirement in order to comply with the PIC/S Guide to GMP 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, 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.

             (3)  An application for a licence to carry out steps in the manufacture of blood, blood components or haematopoietic progenitor cells must include a technical master file in relation to those goods (the relevant technical master file).

             (4)  Blood, blood components and haematopoietic progenitor cells must be manufactured in a manner consistent with the relevant technical master file.

             (5)  A blood processing plant that processes plasma collected from donors in Australia for products that are, or will be, used in Australia (the Australian product) may only be used to process plasma collected from a source outside Australia if, for that source:

                     (a)  a plasma master file prepared in accordance with the requirements of the PMF Guideline has been submitted to a relevant officer by the licence holder of the blood processing plant; and

                     (b)  a relevant officer has advised the licence holder of the plant that, based on the plasma master file submitted for those goods, and having taken into account the processes of the plant, the plasma from the source outside Australia will not contaminate the Australian product with any blood borne pathogens.

             (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.


 

Schedule 2—Repeals

Note:       See section 5.

Therapeutic Goods (Manufacturing Principles) Determination 2018

1  The whole of the instrument

Repeal the instrument.