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MP1/2018 Determinations/Health as amended, taking into account amendments up to Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019
Administered by: Health
General Comments: For transitional provisions relating to the repeal of this determination, see sections 8 and 9 of the Therapeutic Goods (Manufacturing Principles) Determination 2020.
Registered 15 Apr 2019
Start Date 31 Mar 2019
Date of repeal 01 Jul 2020
Repealed by Therapeutic Goods (Manufacturing Principles) Determination 2020
Table of contents.

Therapeutic Goods (Manufacturing Principles) Determination 2018

MP1/2018

made under subsection 36(1) of the

Therapeutic Goods Act 1989

Compilation No. 1

Compilation date:                          31 March 2019

Includes amendments up to:         Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019

 

 

About this compilation

This compilation

This is a compilation of the Therapeutic Goods (Manufacturing Principles) Determination 2018 that shows the text of the law as amended and in force on 31 March 2019 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

  

  

  


Contents

Name of determination                                                                                                                  1

Application                                                                                                                                       1

Interpretation                                                                                                                                   1

Division 1 –Therapeutic Goods including, Active Pharmaceutical Ingredients (API) and Sunscreens, but not Blood, Blood Components, Biologicals (except things that comprise or contain live animal cells, tissues or organs), Plasma, Haematopoietic Progenitor Cells or Therapeutic Devices;                          4

Division 2 – Manufacturing principles for Blood, Blood Components, Biologicals (except things that comprise or contain live animal cells, tissues or organs), Plasma and Haematopoietic Progenitor Cells        5

Division 3 – Therapeutic Devices                                                                                                                  7

Endnotes                                                                                                                        8

Endnote 1—About the endnotes                                                                                                                     8

Endnote 2—Abbreviation key                                                                                                                       9

Endnote 3—Legislation history                                                                                                                  10

Endnote 4—Amendment history                                                                                                                 11

 


Name of determination

1.      This Determination is the Therapeutic Goods (Manufacturing Principles) Determination 2018.

Application

3.      The manufacturing principles applicable to specific therapeutic goods are set out in the following Divisions:

a.         Division 1 – Therapeutic Goods including, Active Pharmaceutical Ingredients (API) and Sunscreens, but not Blood, Blood Components, Biologicals (except things that comprise or contain live animal cells, tissues or organs), Plasma, Haematopoietic Progenitor Cells or Therapeutic Devices;

b.         Division 2 – Blood, Blood Components, Biologicals (except things that comprise or contain live animal cells, tissues or organs), Plasma and Haematopoietic Progenitor Cells;

c.         Division 3 – Therapeutic Devices

Note: The manufacturing principles applicable to therapeutic goods that are things that comprise or contain live animal cells, tissues or organs are those set out in Division 1, and not those set out in Division 2.

Interpretation

4.      In this Determination, unless the contrary intention appears:

active pharmaceutical ingredients (API) means any substance or mixture of substances intended to be used in the manufacture of a medicine and that, when used in the production of a medicine, becomes an active ingredient of that medicine.  These substances are 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.

AS ISO 13485-2003 means the document entitled “AS ISO 13485-2003 Medical devices – Quality management systems – Requirements for Regulatory purposes published by the International Standards Organisation.

biological has the same meaning as in the Act.

blood means whole blood collected from a single human donor and processed either for transfusion or further manufacturing.

blood components means therapeutic components of blood (red cells, white cells, platelets, plasma) that can be prepared by centrifugation, filtration and freezing, but not including haematopoietic progenitor cells.

EN 556 means the document entitled EN 556:1994 “Sterilization of medical devices – requirements for medical devices to be labelled ‘Sterile’, published by the European Standards Committee (CEN) Central Secretariat.

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.

medicine has the same meaning as in the Act.

plasma means plasma, separated from human donor blood, intended for a number of purposes including the production of further blood components, the production of which is  required to be licensed under Chapter 3, Part 3-3 of the Act.

Register has the same meaning as in the Act.

standard has the same meaning as in the Act.

the Act means the Therapeutic Goods Act 1989, as amended from time to time.

the Australian Code of Good Manufacturing Practice means the document titled: “Australian Code of Good Manufacturing Practice for Human Blood, Blood Components, Human tissues and Human cellular therapy products” dated April 2013 and published by the TGA on its website.

 the PIC/S Guide to GMP means the document titled “Guide to Good Manufacturing Practice for Medicinal Products”, PE 009-13, published by the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S) dated 1 January 2017, except for the following Annexes of that document:

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).


 

Technical Master File, for a therapeutic good, means:

a.       compilations of scientific and technical data provided by a manufacturer which include a description of the steps of manufacture that is consistent with the description of steps of manufacture identified in the document entitled "Guideline for the Preparation of Technical Master Files for Blood, Blood Components and Haematopoietic Progenitor Cells", published by the TGA on its website; and

b.      detailed scientific and technical data or information that must satisfy the Secretary that:

                                            i.      the blood or blood components, manufactured using the steps of manufacture mentioned in paragraph (a), will meet Therapeutic Goods (Standard for Blood and Blood Components) (TGO 102) Order 2019; or

                                          ii.      the haematopoietic progenitor cells derived from cord blood manufactured using the steps of manufacture mentioned in paragraph (a) will meet the standard set out in the Therapeutic Goods Order No. 94 (Standard for Haematopoietic Progenitor Cells derived from Cord Blood) 2017; and

                                        iii.      donor selection, testing and the process for minimising infectious disease transmission via therapeutic goods that are human blood and blood components will meet the requirements of Therapeutic Goods Order No. 88 - Standards for donor selection, testing and minimising infectious disease transmission through therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products.

Therapeutic device has the same meaning as in the Act.

TGA means the Therapeutic Goods Administration, a business unit of the Department of Health.


a.        

Division 1 –Therapeutic Goods including, Active Pharmaceutical Ingredients (API) and Sunscreens, but not Blood, Blood Components, Biologicals (except things that comprise or contain live animal cells, tissues or organs), Plasma, Haematopoietic Progenitor Cells or Therapeutic Devices;

Note: The manufacturing principles applicable to therapeutic goods that are things that comprise or contain live animal cells, tissues or organs are those set out in Division 1, and not those set out in Division 2.

(1)          This Division applies to the manufacture of therapeutic goods including API and Sunscreens, other than:

(a)      blood and blood components, plasma and haematopoietic progenitor cells;

(b)     biologicals (except things that comprise or contain live animal cells, tissues or organs);

(c)      therapeutic devices;

(2)          Subject to subclauses (3) and (4), manufacturers in Australia of therapeutic goods that are covered by this Division must follow the procedures and requirements set out in any Part of the PIC/S Guide to GMP, including any Annexes to the PIC/S Guide to GMP that applies to the particular goods being manufactured. 

(3)          Where the PIC/S Guide to GMP provides that a procedure or requirement ‘should’ be followed, manufacturers of therapeutic goods in Australia must follow that 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 the TGA, that the failure to adopt that procedure or requirement:

                                                  i.      will not increase the risk that the goods produced as a result 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; and

                                                ii.      will not increase the risk of the therapeutic goods in question failing to comply with, where applicable both the standard for that therapeutic good and the conditions of the listing or registration for that therapeutic good; and

                                              iii.      will not depart from  the record keeping requirements contained in the PIC/S Guide to GMP; or

(b)     where an alternative procedure to the procedure or requirement set out under an applicable Part of, or Annex to, the PIC/S Guide to GMP has been adopted, the manufacturer demonstrates, to the satisfaction of the TGA, that:

                                                  i.      the alternative procedure will not result in the production of therapeutic goods that could increase the risk of harm or injury to any person or will or could  potentially have the effect of causing or contributing to such harm; and

                                                ii.      the alternative procedure will not increase the risk of the therapeutic goods in question failing to comply with, where applicable, both the standard for that therapeutic good and the conditions of the listing or registration; and

                                              iii.      will not depart from the record keeping requirements contained in the PIC/S Guide to GMP.

(4)          For the purposes of subclause (2), the word “applies” does not include the application, to particular therapeutic goods being manufactured, of an Annex that is stated in the PIC/S Guide to GMP to be ‘voluntary’.

 

Division 2 – Manufacturing principles for Blood, Blood Components, Biologicals (except things that comprise or contain live animal cells, tissues or organs), Plasma and Haematopoietic Progenitor Cells

(5)          This Division applies to the manufacture of blood, blood components, biologicals (except things that comprise or contain live animal cells, tissues or organs), plasma and haematopoietic progenitor cells.

(6)          A manufacturer of blood, blood components, plasma or haematopoietic progenitor cells must lodge a Technical Master File with, an application for a licence under Chapter 3, Part 3-3 of the Act.

(7)          Blood, blood components, plasma and haematopoietic progenitor cells must be manufactured:

(a)    in compliance with applicable requirements of the Australian Code of Good Manufacturing Practice; and

(b)   in a manner consistent with the relevant Technical Master File lodged for the goods with the TGA by the manufacturer.

(8)          Biologicals (except things that comprise or contain live animal cells, tissues or organs) must be manufactured in compliance with applicable requirements of the Australian Code of Good Manufacturing Practice.

(9)          Where the Australian Code of Good Manufacturing Practice provides that a procedure or requirement ‘should’ be followed, manufacturers of therapeutic goods in Australia must follow that procedure or requirement in order to comply with the Australian Code of Good Manufacturing Practice.

(10)      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 European Agency for the Evaluation of Medicinal Products document entitled "Guideline on the scientific data requirements for a plasma master file (PMF) EMEA/CPMP/BWP/3794/03, revision 1(2006)" has been submitted to the Secretary by the licensee of the relevant blood processing plant; and

(b)   the Secretary has advised the licensee of the plant that, based upon the plasma master file submitted for those goods, and having taken into account the plant's processes, the plasma from the source outside Australia will not contaminate the Australian product with any blood borne pathogens.

(11)      The failure of a manufacturer in Australia of therapeutic goods, to which this Division applies, to follow a particular procedure or requirement set out in an applicable Part of 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 the TGA, that the failure to adopt that procedure or requirement:

                                       i.      will not increase the risk that the goods produced as a result 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; and

                                     ii.      will not increase the risk of the therapeutic goods in question failing to comply with, where applicable, both the standard for that therapeutic goods and to the conditions of registration for that therapeutic good; 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 procedure to the procedure or requirements set out under and applicable part of the Australian Code of Good Manufacturing Practice has been adopted, the manufacturer demonstrates, to the satisfaction of the TGA, that:

                                       i.          the alternative procedure will not increase the risk that the goods produced as a result 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; and

                                     ii.          the alternative procedure will not increase the risk of the therapeutic goods in question failing to comply with, where applicable, both the standard for the goods and any conditions of registration that apply to the goods; and

                                 iii.          will not depart from the record keeping requirements contained in the Australian Code of Good Manufacturing Practice.

Division 3 – Therapeutic Devices

(12)      In this Division, the following therapeutic devices must be manufactured in compliance with an approved quality assurance system as follows:

(a)  for a therapeutic device, other than a device incorporating human tissue

                                       i.          if the therapeutic device must be listed in the Register, it must be manufactured in compliance with AS ISO 13485-2003 other than clause 7.3 (Design and Development); or,

                                     ii.          if the therapeutic device must be registered in the Register , it must be manufactured in compliance with AS ISO 13485-2003; and

                                   iii.          if the therapeutic device is labelled ‘Sterile’, it must also be manufactured in compliance with EN 556.


 

Endnotes

Endnote 1—About the endnotes

The endnotes provide information about this compilation and the compiled law.

The following endnotes are included in every compilation:

Endnote 1—About the endnotes

Endnote 2—Abbreviation key

Endnote 3—Legislation history

Endnote 4—Amendment history

Abbreviation key—Endnote 2

The abbreviation key sets out abbreviations that may be used in the endnotes.

Legislation history and amendment history—Endnotes 3 and 4

Amending laws are annotated in the legislation history and amendment history.

The legislation history in endnote 3 provides information about each law that has amended (or will amend) the compiled law. The information includes commencement details for amending laws and details of any application, saving or transitional provisions that are not included in this compilation.

The amendment history in endnote 4 provides information about amendments at the provision (generally section or equivalent) level. It also includes information about any provision of the compiled law that has been repealed in accordance with a provision of the law.

Misdescribed amendments

A misdescribed amendment is an amendment that does not accurately describe the amendment to be made. If, despite the misdescription, the amendment can be given effect as intended, the amendment is incorporated into the compiled law and the abbreviation “(md)” added to the details of the amendment included in the amendment history.

If a misdescribed amendment cannot be given effect as intended, the abbreviation “(md not incorp)” is added to the details of the amendment included in the amendment history.

Endnote 2—Abbreviation key

 

ad = added or inserted

o = order(s)

am = amended

Ord = Ordinance

amdt = amendment

orig = original

c = clause(s)

par = paragraph(s)/subparagraph(s)

C[x] = Compilation No. x

    /sub‑subparagraph(s)

Ch = Chapter(s)

pres = present

def = definition(s)

prev = previous

Dict = Dictionary

(prev…) = previously

disallowed = disallowed by Parliament

Pt = Part(s)

Div = Division(s)

r = regulation(s)/rule(s)

ed = editorial change

reloc = relocated

exp = expires/expired or ceases/ceased to have

renum = renumbered

    effect

rep = repealed

F = Federal Register of Legislation

rs = repealed and substituted

gaz = gazette

s = section(s)/subsection(s)

LA = Legislation Act 2003

Sch = Schedule(s)

LIA = Legislative Instruments Act 2003

Sdiv = Subdivision(s)

(md) = misdescribed amendment can be given

SLI = Select Legislative Instrument

    effect

SR = Statutory Rules

(md not incorp) = misdescribed amendment

Sub‑Ch = Sub‑Chapter(s)

    cannot be given effect

SubPt = Subpart(s)

mod = modified/modification

underlining = whole or part not

No. = Number(s)

    commenced or to be commenced

 

Endnote 3—Legislation history

 

Name

Registration

Commencement

Application, saving and transitional provisions

Therapeutic Goods (Manufacturing Principles) Determination 2018

4 Dec 2017 (F2017L01574)

1 Jan 2018

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

25 Mar 2019 (F2019L00389)

31 Mar 2019

 


 

Endnote 4—Amendment history

 

Provision affected

How affected

s 2........................................

rep LA s 48D

s 4........................................

am F2019L00389