Australian code of good manufacturing practice for medicinal products

5 July 2010

On 29 July 2009, the Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2009 adopted the PIC/S Guide to Good Manufacturing Practice - 15 January 2009, PE 009-8, to be the Code of GMP, except for its Annexes 4, 5 and 14 which are not adopted by Australia.

This updated Code replaces the Australian Code of Good Manufacturing Practice for Medicinal Products (16 August 2002) as well as the Australian Code of Good Manufacturing Practice for sunscreen products (1994).

For both transitions, a one year transition period was applied, ending at 1 July 2010. As per 1 July 2010 the 2002 Code and the sunscreens code are revoked.

The 2009 Code consists of two parts and fifteen annexes. Part I is applicable to the manufacture of finished medicinal products and Part II is applicable to the manufacture of active pharmaceutical ingredients (APIs). Part II is identical to the ICH GMP Guide for APIs, which was already determined as a standard in the previous Manufacturing Principle.

The Annexes are applicable to the manufacture of finished medicinal products, as well as to the manufacture of APIs where relevant. The following Annexes are adopted:

• Annex 1: Manufacture of sterile medicinal products
• Annex 2: Manufacture of biological medicinal products for human use
• Annex 3: Manufacture of radiopharmaceuticals
• Annex 6: Manufacture of medicinal gases
• Annex 7: Manufacture of herbal medicinal products
• Annex 8: Sampling of starting and packaging materials
• Annex 9: Manufacture of liquids, creams and ointments
• Annex 10: Manufacture of pressurised metered dose aerosol preparations for inhalation
• Annex 11: Computerised systems
• Annex 12: Use of ionising radiation in the manufacture of medicinal products
• Annex 13: Manufacture of investigational medicinal products
• Annex 15: Qualification and validation
• Annex 17: Parametric release
• Annex 19: Reference and retention samples
• Annex 20: Quality risk management

Australia has not adopted the PIC/S Guide's Annexes 4 and 5 on the manufacture of veterinary medicines and 14 on products derived from human blood or human plasma. The PIC/S Guide does not include Annexes 16 and 18 as these are specific to the EU GMP Guide.

The TGA has previously published guidelines for the interpretation of the 2002 Code of GMP for complementary medicines manufacture and for medicinal gases manufacture. These documents are currently under revision and updated versions are expected to be available here shortly.