Australian code of good manufacturing practice for medicinal products
The Australian Code of Good Manufacturing Practice for Medicinal Products (16 August 2002), replaces the Australian Code of Good Manufacturing Practice for Therapeutic Goods - Medicinal Products (August 1990), the Australian Code of Good Manufacturing Practice for Therapeutic Goods - Medicinal Gases (July 1992) and the Investigational Medicinal Products Code of GMP (Annex 13, EC GMP Guide, 1997).
The new Code is based entirely on the international standard entitled Guide to Good Manufacturing Practices for Medicinal Products, version PH 1/97 (Rev. 3), 15 January 2002, published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S). The modifications to that Guide and its adoption as the Australian Code of Good Manufacturing Practice, is done so with the expressed permission of the PIC/S.
The Australian Code of Good Manufacturing Practice for Medicinal Products (16 August 2002) was fully implemented on 21 August 2003 after a 12 month transition period and is the basis for licensing all Australian manufacturers of medicinal products.
The Australian Code of Good Manufacturing Practice for Medicinal Products 2002 will be revoked on 1 July 2010 and will be replaced by the PICS Guide for Good Manufacturing Practice for Medicinal Products 2009, as adopted in Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2009.
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Australian code of good manufacturing practice for medicinal products (pdf,577kb)
Contents
- Introduction
- Interpretation
- Chapter 1 - Quality Management
- Chapter 2 - Personnel
- Chapter 3 - Premises and Equipment
- Chapter 4 - Documentation
- Chapter 5 - Production
- Chapter 6 - Quality Control
- Chapter 7 - Contract Manufacture and Analysis
- Chapter 8 - Complaints and Product Recall
- Chapter 9 - Self Inspection
- Annexes
- Annex 1 Manufacture of sterile medicinal products
- Annex 2 Manufacture of biological medicinal products for human use
- Annex 3 Manufacture of radiopharmaceuticals
- Annex 4 [Manufacture of veterinary medicinal products other than immunologicals] *This PIC/S Annex is not adopted by the Australian Code of Good Manufacturing Practice for Medicinal Products, 16 August 2002.
- Annex 5 [Manufacture of immunological veterinary medical products] *This PIC/S Annex is not adopted by the Australian Code of Good Manufacturing Practice for Medicinal Products, 16 August 2002.
- 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 14 [Manufacture of products derived from human blood or human plasma] *This PIC/S Annex is not adopted by the Australian Code of Good Manufacturing Practice for Medicinal Products, 16 August 2002.
- Annex 15 Qualification and validation
- Annex 16 [Qualified person and batch release] *This Annex is specific to the EU GMP Guide and has not been adopted by Australia.
- Annex 17 Parametric release
- Annex 18 [GMP Guide for active pharmaceutical ingredients] *Australia has adopted the ICH GMP Guide for APIs as a Manufacturing Principle.
- Glossary