Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2000 (Cth)

COMMONWEALTH OF AUSTRALIA

Therapeutic Goods Act 1989

Therapeutic Goods (Manufacturing Principles)

Determination No 1 of 2000

MP1/2000

I, TERRY SLATER, delegate of the Minister for Health and Aged Care for the purpose of section 36 of the Therapeutic Goods Act 1989 and acting under subsection 36(1) of that Act:

(a)AMEND the Therapeutic Goods Manufacturing Principles No.1 of 1999 by:

(i)   deleting the following definitions:

“Human Tissues Code of GMP”; and

“Blood and Blood Components Code of GMP”

from Clause 4, “Definitions”, of those Manufacturing Principles; and

(ii)  deleting subclauses 5(1) and (3) of those Manufacturing Principles;  AND

(b)DETERMINE the following principles to be observed in the manufacture of all blood and blood components for use in humans.

Dated this            22nd day of September 2000  

Terry Slater

Delegate of the Minister for Health and Aged Care

Citation

1. This Determination may be cited as the Therapeutic Goods (Manufacturing Principles) Determination No 1 of 2000;

Commencement

1. This Determination commences on the date it is gazetted.

[Note: see Acts Interpretation Act 1901, s.46A and s.48.]

Interpretation

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

“the Act” means the Therapeutic Goods Act 1989;

“Blood” means whole blood extracted from human donors.

“Blood components” means therapeutic components that have been manufactured from blood (including red cells, white cells, stem cells, platelets and  plasma), except for products produced through fractionation of plasma

“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 Part 4 of the Act;

“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;

“Therapeutic Goods Order No.66” is the standard determined by the Minister for the purposes of subsection 10(1) of the Act and gazetted on 24 August 2000.

“Technical Master Files” are:

(a)    compilations of scientific data provided by a manufacturer which include a description of the steps in 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 Components”, published by the Commonwealth Department of Health and Aged Care in the Commonwealth Gazette on 23 August 2000; and

(b) detailed technical and scientific data or information that must satisfy the Secretary that the blood or blood components manufactured, using the steps of manufacture described in paragraph (a) above, will meet with Therapeutic Goods Order No. 66.

Compliance with a Quality Assurance System

1. A manufacturer of blood or blood components must lodge a Technical Master File with an application for a licence under Part 4 of the Act;

1. Blood and blood components and plasma must be manufactured:

(i)in compliance with The Australian Code of GMP for Human Blood and Tissues and

(ii)in a manner consistent with the relevant  Technical Master Files lodged by the manufacturer.

1. Human tissues must be manufactured in compliance with the Australian Code of GMP for Human Blood and Tissues.