On 29 July 2009, the Therapeutic Goods (Manufacturing
Principles) Determination No 1 of 2009 adopted the Guide
to Good Manufacturing Practice - 15 January 2009 as issued by the
Pharmaceutical Inspection Convention and Pharmaceutical Inspection
Co-operation Scheme (PIC/S) to become the new Code
of Good Manufacturing Practice for Medicinal Products (New
GMP). The New GMP became mandatory from 1 July 2010.
The New GMP replaces the previous Australian Code of Good
Manufacturing Practice for Medicinal Products (2002) and the
Australian Code of Good Manufacturing Practice for sunscreen
products (1994). There are currently 35 national authorities
participating in PIC/S. The New GMP is aligned with the PIC/S guide
and harmonises procedures and technical standards with
international inspection standards for the production and testing
of medicinal products, which will allow the TGA to establish mutual
recognition agreements with overseas authorities and help reduce
regulatory compliance burdens.
The most significant changes for manufacturers of medicinal
the requirement to prepare annual Product Quality Reviews
the requirement to use quality risk management
detailed procedures on stability testing
detailed procedures on reference and retention samples,
several changes for the manufacture of sterile medicinal
products are also included in Annex 1.
The New GMP consists of two parts:
Part I - manufacture of finished medicinal products
Part II - manufacture of Active Pharmaceutical Ingredients
The provisions of the New GMP are outlined in annexures as
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This publication is intended as a first point of reference and
should not be relied on as a substitute for professional advice.
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