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Therapeutic Goods Regulation: Complementary Medicines Auditor General Audit Report No 3

Therapeutic Goods Regulation: Complementary Medicines Auditor General Audit Report No 3

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Therapeutic Goods Regulation: Complementary Medicines Auditor General Audit Report No 3 - 2011-12
Therapeutic Goods Regulation: Complementary Medicines Auditor General Audit Report No 3 - 2011-12

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Published by: PaulGallagher on Aug 31, 2011
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8.

Good Manufacturing Practice (GMP) is a set of manufacturing
principles and procedures which, when applied by manufacturers,
helps to ensure a high level of quality of manufacture of therapeutic
products.

9.

The definition of ‘manufacture’ within the context of GMP is to
produce therapeutic goods and to engage in any part of the process in
the production of the goods, such as bringing the goods to their final
state, engaging in the assembling, packaging, labelling, storage,
sterilising, testing or releasing for supply of the goods, or of any
component or ingredient of the goods as part of that process.396 Within
this definition, GMP applies to manufacturers of finished medicinal
products, the raw materials that constitute them, and those involved in
packaging a product.

Australian requirements

10.

The Act requires manufacturers of therapeutic goods in Australia to
hold a licence. It also allows the minister, from time to time, to
determine written principles to be observed in the manufacture of
therapeutic goods for humans.397 In practice, to obtain a licence, a
manufacturer must demonstrate compliance with requirements defined
in principles called ‘Good Manufacturing Practice’.

11.

In 2002, the Australian Government announced that the principles of
GMP would be aligned to standards established by an international
body, the Pharmaceutical Inspection Convention/Pharmaceutical
Inspection Cooperation Scheme (jointly referred to as ‘PIC/S’). The TGA

396

TGA, Good Manufacturing Practice for Therapeutic Goods, 31 July 2009, available from
[accessed 8 August 2011].

397

Therapeutic Goods Act 1989, s. 36(1).

ANAO Audit Report No.3 2011–12
Therapeutic Goods Regulation: Complementary Medicines

164

is currently one of 39 international regulatory authorities participating
in the PIC/S.398

12.

Since 2002, the Australian GMP requirements have been realigned with
amendments to the PIC/S (in 2002, 2007 and 2009). Most recently, on
29 July 2009, a further amendment took place whereby a one year
transition period was applied, ending on 1 July 2010, after which point
the 2002 medicinal products and 1994 sunscreens codes were
revoked.399

13.

The PIC/S GMP standards seek to ‘further facilitate the removal of
barriers to trade in medicinal products, to promote uniformity in
licensing decisions and to ensure the maintaining of high standards of
quality assurance in the development, manufacture and control of
medicinal products’.400

14.

GMP applies to both Australian and overseas manufacturers.
Recognised compliance with GMP obtained through successfully
completing a GMP audit. Once a therapeutic good is included on the
ARTG, the manufacturer undergoes periodic audits against GMP
requirements to ensure they maintain compliance. Failure to do so can
result in removal of the product from the ARTG or other regulatory
action. The Act provides for criminal offences and civil penalties for
breach of manufacturing principles.

15.

The TGA’s Office of Manufacturing Quality (OMQ) is responsible for
conducting GMP audits. When it is satisfied that GMP requirements
are met, a delegate of the Secretary, DoHA, issues GMP licences for
Australian therapeutic goods manufacturers or GMP clearances to an
overseas manufacturer. Currently, Australia recognises GMP clearances
issued by foreign regulators. This is based on the adoption of PIC/S by
those regulators, and associated agreements and memoranda of
understanding between Australia and the respective countries.

398

Pharmaceutical Inspection Co-operation Scheme, Welcome to the PIC/S Website, available from
[accessed 8 August 2011].

399

Before July 2009, Australia had its own Codes of GMP for manufacture of medicinal products and
sunscreens: the Australian Code of Good Manufacturing Practice for Medicinal Products (16 August
2002) and the Australian Code of Good Manufacturing Practice for Sunscreen Products (1994).

400

PIC/S, Guide to Good Manufacturing Practice for Medicinal Products: PE 009-9 (Intro), 2009, available
from [accessed 8 August 2011].

ANAO Audit Report No.3 2011–12
Therapeutic Goods Regulation: Complementary Medicines

164

is currently one of 39 international regulatory authorities participating
in the PIC/S.398

12.

Since 2002, the Australian GMP requirements have been realigned with
amendments to the PIC/S (in 2002, 2007 and 2009). Most recently, on
29 July 2009, a further amendment took place whereby a one year
transition period was applied, ending on 1 July 2010, after which point
the 2002 medicinal products and 1994 sunscreens codes were
revoked.399

13.

The PIC/S GMP standards seek to ‘further facilitate the removal of
barriers to trade in medicinal products, to promote uniformity in
licensing decisions and to ensure the maintaining of high standards of
quality assurance in the development, manufacture and control of
medicinal products’.400

14.

GMP applies to both Australian and overseas manufacturers.
Recognised compliance with GMP obtained through successfully
completing a GMP audit. Once a therapeutic good is included on the
ARTG, the manufacturer undergoes periodic audits against GMP
requirements to ensure they maintain compliance. Failure to do so can
result in removal of the product from the ARTG or other regulatory
action. The Act provides for criminal offences and civil penalties for
breach of manufacturing principles.

15.

The TGA’s Office of Manufacturing Quality (OMQ) is responsible for
conducting GMP audits. When it is satisfied that GMP requirements
are met, a delegate of the Secretary, DoHA, issues GMP licences for
Australian therapeutic goods manufacturers or GMP clearances to an
overseas manufacturer. Currently, Australia recognises GMP clearances
issued by foreign regulators. This is based on the adoption of PIC/S by
those regulators, and associated agreements and memoranda of
understanding between Australia and the respective countries.

398

Pharmaceutical Inspection Co-operation Scheme, Welcome to the PIC/S Website, available from
[accessed 8 August 2011].

399

Before July 2009, Australia had its own Codes of GMP for manufacture of medicinal products and
sunscreens: the Australian Code of Good Manufacturing Practice for Medicinal Products (16 August
2002) and the Australian Code of Good Manufacturing Practice for Sunscreen Products (1994).

400

PIC/S, Guide to Good Manufacturing Practice for Medicinal Products: PE 009-9 (Intro), 2009, available
from [accessed 8 August 2011].

Appendix 1

ANAO Audit Report No.3 2011–12
Therapeutic Goods Regulation: Complementary Medicines

165

16.

The Act requires overseas manufacturers that supply therapeutic goods
to Australia to meet at least an equivalent standard of GMP as
Australian manufacturers. To avoid the need for an international
on‐site audit by the TGA, sponsors may submit an acceptable form of
evidence of the standard of manufacture for assessment (GMP
clearance) before or when applications are lodged for
listing/registration of medicines.401

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