GMP sets minimum requirements for premises, equipment, personnel, documentation, and quality-control processes involved in manufacturing therapeutic goods. The aim is to ensure that products are consistently produced and controlled to the quality standards appropriate for their intended use. In Australia, compliance with GMP is a legal requirement under the Therapeutic Goods Act 1989 (Cth) for manufacturers of goods listed or registered on the Australian Register of Therapeutic Goods (ARTG).
The TGA administers GMP licensing through a system of manufacturer licences and overseas GMP clearances. Domestic manufacturers must hold a valid TGA manufacturing licence; overseas manufacturers supplying the Australian market must demonstrate compliance with GMP standards acceptable to the TGA, which may involve assessment against the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to GMP , the international benchmark Australia formally adopted. Australia became a PIC/S member in 1994, aligning local requirements with those of over 50 participating regulatory authorities worldwide.
For manufacturers of complementary medicines and plant-based products , including those containing cannabinoids , GMP compliance is equally mandatory. Cannabis medicines, classified under Schedule 4 or Schedule 8 of the Poisons Standard depending on their formulation, must be manufactured under TGA-licenced and GMP-compliant conditions. The TGA conducts GMP inspections and can suspend or cancel a manufacturing licence where serious deficiencies are found, which may result in goods being removed from the ARTG or recalled from the market.
GMP should not be confused with product approval. A GMP licence or clearance confirms that a facility meets manufacturing quality standards; it does not constitute approval of any specific product for sale, nor does it imply that a product has demonstrated safety or efficacy for any indication. These are separate regulatory steps under the ARTG evaluation process.
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