Therapeutic Goods Act 1989
 
Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2007
MP1/2007
 
I, ROHAN HAMMETT, delegate of the Minister for Health and Ageing for the purpose of section 36 of the Therapeutic Goods Act 1989 and acting under subsection 36(1) of that Act, determine the following principles to be observed in the manufacture of therapeutic goods for use in humans.
 
Dated      12th December       2007
 
Signed
DR  ROHAN HAMMETT
Delegate of the Minister for Health and Ageing
 
Citation
1. This Determination may be cited as the Therapeutic Goods (Manufacturing Principles) Determination No 1 of 2007.
Commencement
2. This Determination commences the day after it is registered in the Federal Register of Legislative Instruments.
[Note: see Legislative Instruments Act 2003 section 12.]
Revocation
3. This Determination revokes the following instruments:
 
·        Therapeutic Goods (Manufacturing Principles) Determination number 1 of 1999 published in the Commonwealth of Australia Gazette, No.GN 37, 15 September 1999
·        Therapeutic Goods (Manufacturing Principles) Determination No.1 of 2000, published in the Commonwealth of Australia Special Gazette, No. S 518, 28 September 2000
·        Therapeutic Goods (Manufacturing Principles) Determination No.2 of 2002, published in the Commonwealth of Australia Gazette, No. GN 34, 28 August 2002.
Introduction
4. The manufacturing principles applicable to specific therapeutic goods are set out in the following Divisions:
(a) Division 1 – Medicines
(b) Division 2- Blood, blood components, haematopoietic progenitor cells and tissues
(c) Division 3 – Other therapeutic goods not covered by Divisions 1 to 2.
Interpretation
5. In this Determination, unless the contrary intention appears:
"active pharmaceutical ingredients" means any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. 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.
"blood" means whole blood extracted from human donors.
"blood components" means therapeutic components that have been manufactured from blood including red cells, white cells, platelets and plasma, except for products produced through fractionation of plasma.
"EN 556" means the document entitled EN 556: 1994 "Sterilization of medical devices -requirements for medical devices to be labeled 'Sterile', published by the European Standards Committee (CEN) Central Secretariat.
“haematopoietic progenitor cells” means primitive pluripotent haematopoietic progenitor cells capable of self-renewal as well as maturation into any of the haematopoietic lineages, including committed and lineage-restricted progenitor cells.
"medicine" has the same meaning as "medicine" in subsection 3(1) of the Therapeutic Goods Act 1989.
"plasma" means plasma, separated from human donor blood, intended for a number of purposes including the production of further blood components required to be licensed under Chapter 3, Part 3-3 of the Act.
"Sunscreen Code of GMP" means Chapters 1 to 9 inclusive, and the glossary of the document entitled "Australian Code of Good Manufacturing Practice for Therapeutic Goods -Sunscreen Products", published by the Commonwealth Department of Human Services and Health in February 1994.
"sunscreen products" means the goods mentioned in Item 7, Part 1 of Schedule 4 to the Therapeutic Goods Regulations 1990.
"the Act" means the Therapeutic Goods Act 1989.
"The Australian Code of GMP for Human Blood and Tissues" means the document entitled "The Australian Code of Good Manufacturing Practice for Human Blood and Tissues" published by the Commonwealth Department of Health and Aged Care and dated 24 August 2000.
"the Code" means the document entitled "Australian Code of Good Manufacturing Practice For Medicinal Products" dated 16 August 2002, the availability of which was gazetted on 21 August 2002 in the Commonwealth Gazette.
"Technical Master File”, for a therapeutic good, means:
compilations of scientific 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 Therapeutic Goods Administration, a division of the Commonwealth Department of Health and Ageing, on its website ; and detailed technical and scientific 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 Order No. 74 - Standard for Blood Components; or
(ii)                the haematopoietic progenitor cells derived from cord blood manufactured using the steps of manufacture mentioned in paragraph (a) will meet Therapeutic Goods Order No. 75 – Standard for Haematopoetic Progenitor Cells derived from Cord Blood.
Note  Therapeutic Goods Orders 74 and 75 are registered on the Federal Register of Legislative Instruments – see http:www.frli.gov.au.
Division 1- Manufacturing principles for all medicines
6.       The following manufacturing principles under this Division apply to the manufacture of all medicines, except:
active pharmaceutical ingredients; sunscreens products;  blood, blood components, plasma and haematopoietic progenitor cells; and human tissue.
Compliance with the Code in the manufacture of medicines
 
7.       Medicines to which this Division applies must be manufactured in compliance with the Code.
Division 2 - Manufacturing principles to be observed in the manufacture of  blood, blood components, plasma, haematopoietic progenitor cells, and tissues for use in humans.
8.       A manufacturer of blood, blood components, plasma and haematopoietic progenitor cells must lodge a Technical Master File with an application for a licence under Chapter 3, Part 3-3 of the Act;
9.       Blood, blood components, plasma and haematopoietic progenitor cells must be manufactured:
(a)      in compliance with the Australian Code of GMP for Human Blood and Tissues and
(b)      in a manner consistent with the relevant Technical Master File lodged by the manufacturer.
10           Human tissues must be manufactured in compliance with the Australian Code of GMP for Human Blood and Tissues.
12.     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” 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, based upon the plasma master file, and having taken into account the plant's processes, that the plasma from the source outside Australia will not contaminate the Australian product with any blood borne pathogens.
 
Division 3 – Manufacturing principles for other products not covered by Divisions 1 and 2
Compliance with a quality assurance system
13.     In this Division, the following therapeutic goods must be manufactured in compliance with an approved quality assurance system as follows:
(a)     for a therapeutic device, other than human tissues or a device incorporating human tissue:
                                          i.            if the therapeutic device must be listed on the Australian Register of Therapeutic Goods, 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 on the Australian Register of Therapeutic Goods, it must be manufactured in compliance with AS ISO 13485-2003; and
                                       iii.            if the therapeutic device is labeled 'Sterile', it must also be manufactured in compliance with EN 556.
(b)     a sunscreen product must be manufactured in compliance with the Sunscreen Code of GMP.