Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2002
MP1/2002 - Manufacturing principle for active pharmaceutical ingredients (APIs)
Published in the Commonwealth of Australia Gazette, No. GN 21, 29 May 2002
In June 2001, the Therapeutic Goods Committee recommended that the International Conference on Harmonisation (ICH) Guideline Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients be adopted as a Manufacturing Principle for the auditing and licensing of manufacturers of APIs in Australia. The application of MP1/2002 to overseas manufacturers of APIs used in therapeutic goods supplied to Australia will continue to apply only to prescription medicines evaluated by the Drug Safety and Evaluation Branch of the TGA.
The Guideline was gazetted as a Manufacturing Principle on 29 May 2002.
Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2002
COMMONWEALTH OF AUSTRALIA
Therapeutic Goods Act 1989
Therapeutic Goods (Manufacturing Principles) Determination No 1 of 2002
MP1/2002
I, PATRICIA MARY WORTH, Parliamentary Secretary to the Minister for Health and Ageing for the purposed 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 active pharmaceutical ingredients for medicines for use in humans.
Dated this third day of April 2002
Patricia Mary Worth
Parliamentary Secretary to the Minister for Health and Ageing
Citation
- This Determination may be cited as the Therapeutic Goods (Manufacturing Principles) Determination No 1 of 2002.
Commencement
- This Determination commences on the date it is gazetted in the Commonwealth Gazette.
[Note: See Acts Interpretation Act 1901, ss.46A and 48]
Interpretation
- In this Determination, unless the contrary intention appears:
"Active Pharmaceutical Ingredients" means any substance or mixture of 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.
"Determination" means the Therapeutic Goods (Manufacturing Principles) Determination No 1 of 2002.
"ICH" means the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceutical for Human Use.
"the Code" means the entire document (including the "Glossary") entitled the "ICH Harmonised Tripartite Guideline, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients", as at the date of this Determination, and;
- developed by the appropriate ICH Expert Working Group and recommended by the ICH Steering Committee for adoption by the regulatory bodies of the European Union, Japan and the USA; and
- published by the ICH Secretariat, c/o IFPMA, 30 rue de St. Jean, PO BOX 758, 1211 Geneva 13 Switzerland and available from www.ifpma.org/ich5q.html; and
- modified as follows:
- the term "Guide", wherever appearing in the Code, including in the title of the Code, is replaced by the term "Code";
- the term "guidance" in line 1, paragraph 1 of subsection 1.1 is replaced by the words "a Code";
- delete the following words appearing in the second paragraph of subsection 1.1 of the Code:
"In this Guide the term "should" indicated recommendations that are expected to apply unless shown to be inapplicable or replaced by an alternative demonstrated to provide at lease an equivalent level of quality assurance",
and replace with the following words:
"In this Code the term "should" means "must" and the activities, descriptions or specifications accompanied by the word "should" are intended to be mandatory, unless the manufacturer is able to demonstrate that the activity, description or specification is inapplicable or can be replaced by an alternative which must be demonstrated to provide at least an equivalent level of quality assurance"; - delete the fourth paragraph of subsection 1.3 and replace with the following paragraph:
"Section 19 contains requirements that only apply to the manufacture of API's used in the production of drug (medicinal) products specifically for clinical trials (investigational medicinal products)";
and - The words "guidance in this document" appearing in the second last paragraph of subsection 1.3 of the Codes is replaced with the word "Code".
"medicine" has the same meaning as "medicine" in subsection 3(1) of the Therapeutic Goods Act 1989.
Each of the terms "medicinal products", "drug products" or "drug (medicinal) products" referred to in the Code or this Determination means "medicine".
Compliance with the Code for Active Pharmaceutical Ingredients
- Active pharmaceutical ingredients, up to the point immediately prior to these ingredients being rendered sterile, for use in medicines described in Parts 1, 2 and 3 of Schedule 10 of the Therapeutic Goods Regulations must be manufactured in compliance with this Determination.
- The manufacture and supply of sterile active pharmaceutical ingredients must comply with both the Australian Code of Practice for Medicines and this Determination.
- This Determination covers active pharmaceutical ingredients that are manufactured by chemical synthesis, extraction, cell culture/fermentation, by recovery from natural sources, or by any combination of these processes.