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 Products -- Medicinal Gases (July 1992) and investigational
medicinal Code of Good Manufacturing Practices (Appendix 13, Guide to
good manufacturing practice EC, 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 Program
of Cooperation (PIC / S). The amendments to the Guide and its adoption
as the Australian Code of Good Manufacturing Practices, is made with
the express authorization of PIC / S.
The Australian Code of
Good Manufacturing Practice for Medicinal Products (16 August 2002) had
been fully implemented on 21 August 2003 after a period of 12 months of
transition and is the basis for licensing of all Australian
manufacturers of medicines.
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 Products -- Medicinal Gases (July 1992) and investigational
medicinal Code of Good Manufacturing Practices (Appendix 13, Guide to
good manufacturing practice EC, 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 Program
of Cooperation (PIC / S). The amendments to the Guide and its adoption
as the Australian Code of Good Manufacturing Practices, is made with
the express authorization of PIC / S.
The Australian Code of
Good Manufacturing Practice for Medicinal Products (16 August 2002) had
been fully implemented on 21 August 2003 after a period of 12 months of
transition and is the basis for licensing of all Australian
manufacturers of medicines.
