Therapeutic Goods (Manufacturing Principles) Determination No

Therapeutic Goods Act 1989

Therapeutic Goods (Multi-Site Manufacturing Licences) Guidelines of 2010

I, MICHEL LOK, delegate of the Secretary to the Department of Health and Ageing for the purpose of section 38A of the Therapeutic Goods Act 1989 and acting under that section of that Act, make these guidelines setting out the circumstances in which a manufacturing licence may cover two or more manufacturing sites.

Dated 15 March 2010

(signed by)

MICHEL LOK

Delegate of the Secretary to the Department of Health and Ageing

1. Citation

These Guidelines may be cited as the Therapeutic Goods (Multi-Site Manufacturing Licences) Guidelines of 2010.

2. Commencement

These Guidelines commence on the day after they are registered in the Federal Register of Legislative Instruments.

[Note: see Legislative Instruments Act 2003 section 12.]

3. Interpretation

(1) In this Determination, unless the contrary intention appears:

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;

finished product means a therapeutic good other than a medical device that has undergone all stages of production, including packaging in its final container;

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;

in-process materials means a therapeutic good other than a medical device that consists of partly processed starting material which must undergo further manufacturing steps before it becomes a final therapeutic product or bulk medicine;

licence means a licence under Part 3-3 of the Act;

licence variation means a variation of the licence in accordance with section 40B of the Act;

medical device has the same meaning as in section 3 of the Act;

medicine has the same meaning as in section 3 of the Act;

packaging materials means any material that will be used in the packaging of medicinal products, excluding any outer packaging or container required solely to transport or ship the medicinal products.

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;

quality system means the organisational structure, responsibilities, procedures, instructions, processes and resources for implementing quality management;

starting materials means:

(a) in relation to therapeutic goods other than medical devices and blood, blood components, plasma, haematopoietic progenitor cells or human tissue – any substance used in the production of a therapeutic good, but excluding packaging materials;

(b) in relation to blood, blood components, plasma, haematopoietic progenitor cells or human tissue – any material employed in the manufacture which may contact or be included in the finished product including the donation;

supply has the same meaning as in section 3 of the Act;

the Act means the Therapeutic Goods Act 1989;

therapeutic goods has the same meaning as in section 3 of the Act;

TGA means the Therapeutic Goods Administration, a division of the Department of Health and Ageing.

(2) A reference to “secondary packaging” in relation to goods is a reference to the packing of the goods in packaging not intended to be in direct contact with the goods.

4. Manufacture of therapeutic goods other than medical devices and blood, etc.

(1) For the manufacture of a particular kind of therapeutic good (other than medical devices and blood, blood components, plasma, haematopoietic progenitor cells or human tissue) a licence may cover two or more manufacturing sites where all of the following criteria are satisfied:

(a) steps of manufacturing for that kind of therapeutic good are performed at one site, and any additional site or sites are used either for:

(i) the storage of packaging materials, starting materials or in-process materials in relation to that kind of therapeutic good or the storage of the finished product; or

(ii) the storage of packaging materials, starting materials or in-process materials in relation to that kind of therapeutic good or the storage of the finished product; and

(A) the undertaking of steps of manufacturing consisting of the secondary packaging of that kind of therapeutic good; or

(B) releasing for supply those materials or the finished product,

or both; and

(b) the manufacturing steps carried out in all the manufacturing sites on the licence will be within the defined scope of a single quality system; and

(c) the TGA is satisfied that all the sites covered by the licence can be audited within the relevant on-site audit period and that once an on-site audit has commenced, the total travel time between all the sites will not exceed 60 minutes.

(2) The holder of a manufacturing licence for the manufacture of a particular kind of therapeutic good (other than medical devices and blood, blood components, plasma, haematopoietic progenitor cells or human tissue) where the steps of manufacturing for that kind of therapeutic good are performed at a site to which the licence relates may seek a variation of the licence to add one or more additional manufacturing sites where:

(a) the additional site or sites are to be used either for:

(i) the storage of packaging materials, starting materials or in-process materials in relation to that kind of therapeutic good or the storage of the finished product, or

(ii) the storage of packaging materials, starting materials or in-process materials in relation to that kind of therapeutic good or the storage of the finished product; and

(A) the undertaking of steps of manufacturing consisting of the secondary packaging of that kind of therapeutic good; or

(B) releasing for supply those materials or the finished product,

or both; and

(b) the manufacturing steps carried out in all the manufacturing sites on the licence will be within the defined scope of a single quality system; and

5. Manufacture of blood, blood components, plasma, haematopoietic progenitor cells or human tissue

(1) For the manufacture of blood, blood components, plasma, haematopoietic progenitor cells or human tissue, a licence may cover two or more manufacturing sites where all of the following criteria are satisfied:

(a) steps of manufacturing for that kind of therapeutic good are performed at one fixed site; and

(b) any additional mobile (non-fixed) site or sites are used for the collection of blood or blood components; and

(c) any additional fixed site or sites are used for the storage of starting materials or in-process materials in relation to that kind of therapeutic good or the storage of the finished product; and

(d) the manufacturing steps carried out in all the manufacturing sites on the licence will be within the defined scope of a single quality system; and

(e) the TGA is satisfied that all the sites covered by the licence can be audited within the relevant on-site audit period and that once an on-site audit has commenced, the total travel time between all the fixed sites will not exceed 60 minutes.

(2) The holder of a manufacturing licence for the manufacture of a particular kind of therapeutic goods being blood, blood components, plasma, haematopoietic progenitor cells or human tissue where steps of manufacturing for that kind of therapeutic good are performed at a site to which the licence relates may seek a variation of the licence to add one or more additional manufacturing sites where:

(a) any additional mobile (non-fixed) site or sites are used for the collection of blood or blood components; and

(b) any additional fixed site or sites are used for the storage of starting materials or in-process materials in relation to that kind of therapeutic good or the storage of the finished product; and

(c) the manufacturing steps carried out in all the manufacturing sites on the licence will be within the defined scope of a single quality system; and

(d) the TGA is satisfied that all the sites covered by the licence can be audited within the relevant on-site audit period and that once an on-site audit has commenced, the total travel time between all the fixed sites will not exceed 60 minutes.