As a TGA GMP consultant, I’m often asked: “How frequently will I be inspected?”
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As a TGA GMP consultant, I’m often asked: “How frequently will I be inspected?”

Many manufacturers want to know how often they will be inspected – which can be a complex question to answer. The TGA employs a risk-based approach to the frequency of manufacturer inspections, in addition to numerous other factors. How does the TGA determine inspection frequency? The TGA uses inspection frequency matrices to guide the frequency…

As a TGA GMP consultant, I’m often asked: “How long does it take to get a TGA manufacturing licence?”
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As a TGA GMP consultant, I’m often asked: “How long does it take to get a TGA manufacturing licence?”

If I had a dollar for every time I was asked this question, I could retire! Thankfully, the TGA issued their commitment to timeframes on the 1st of May 2013. These are the TGA’s performance targets and are subject to cooperation of the TGA GMP inspector, manufacturer, sponsor and in some cases, international regulatory authorities….

As a TGA GMP consultant, I’m often asked… “Do you have any examples of Critical and Major deficiencies?”
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As a TGA GMP consultant, I’m often asked… “Do you have any examples of Critical and Major deficiencies?”

There can often be some confusion between the terms ‘Critical’ and ‘Major’ deficiency. On the 1st May 2013, the TGA helped to answer this question by issuing a list of typical inspection deficiencies and their risk categorisation! This is of immense help to the industry. Critical deficiency A critical deficiency is a deficiency which has…

Medical Device Reforms – Navigating the Impact of EU Reforms on the Reclassification of select Medical Devices in Australia
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Medical Device Reforms – Navigating the Impact of EU Reforms on the Reclassification of select Medical Devices in Australia

Recognising the impact of the European Union (EU) reforms from the overhaul of medical device directives (MDD) and in vitro device directives (IVD) to regulations (MDR/IVDR), Australia’s therapeutic goods regulator, the Therapeutic Goods Administration (TGA) have proactively engaged in public consultations to align Australian medical device regulations with the new EU framework.  Consultations commenced in…

Description of a possible joint regulatory scheme for therapeutic products under ANZTPA

Description of a possible joint regulatory scheme for therapeutic products under ANZTPA

In June 2011, the Australian and New Zealand Governments announced their agreement to proceed with a joint scheme for regulation of therapeutic products (that is, medicines, medical devices, biological and others) to be administered by the Australia New Zealand Therapeutic Products Agency (ANZTPA). The new Agency will replace the Australian Therapeutic Goods Administration (TGA) and…