Manufacturing principles - new/amended requirements
29 September 2009
On 29 July 2009 the TGA National Manager determined new principles to be observed for manufacturers of medicinal products (including active pharmaceutical ingredients and sunscreen products) under Section 36(1) of the Therapeutic Goods Act 1989.
Therapeutic Goods (Manufacturing Principles) Determination No 1 of 2009 <http://www.tga.gov.au/legis/mp0901.htm> brings Australian manufacturing requirements into line with current international practices by adopting the PIC/S Guide for Good Manufacturing Practice for Medicinal Products - 15 January 2009 <http://www.tga.gov.au/manuf/picsgmpmed.htm> issued by the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) in January 2009. The PIC/S Guide also incorporates the ICH Harmonised Tripartite Guideline Good Manufacturing Practice for Active Pharmaceutical Ingredients.
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This document identifies the major changes associated with the adoption of the 2009 PIC/S Guide compared to the current Australian Code of Good Manufacturing Practices for Medicinal Products, 2002.