TGA announces changes in the manufacturing principles

In Australia, the TGA announced a significant change on 29 July 2009. New principles are 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 brings Australian manufacturing requirements into line with current international practices by adopting the Guide to Good Manufacturing Practice for Medicinal Products 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 and the API inspection pilot project between the TGA, FDA and EMEA.

The TGA's adoption of harmonised international standards helps to minimise the regulatory burden on Australian companies seeking to compete in the global economy and preserves Australia's equivalence with its regulatory partners under the provisions of several Mutual Recognition Agreements for GMP inspections and certifications.

The most significant changes in this update to the Manufacturing Principles relate to product quality reviews and sterility requirements in Annex 1.

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Product quality reviews

Product quality reviews will involve periodic assessment of past reviews, in-process controls, failed batches, deviations and non-conformities, process or equipment changes, marketing authorisation variations, stability results, complaints and recalls and technical agreements to identify improvements.

Sterility requirements

Annex 1 relating to the manufacture of sterile medicinal products reflects changes to particle count limits, airflow monitoring in Grade A processing areas, protective clothing requirements, limits to aseptic process media fills and capping and crimping aseptically filled vials.

Stability requirements

The PIC/S Guide also includes explicit requirements for monitoring product stability over the shelf life of a product and permits the voluntary use of risk management tools to demonstrate compliance with the Guide.

The 2009 PIC/S Guide is available here.