The Therapeutic Goods Administration (TGA) launched the Medical Device Single Audit Program (MDSAP) pilot program, starting from January 2014, together with Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, and the US Food and Drug Administration (USFDA). The TGA and MDSAP participation The MDSAP is designed to ensure a single audit of a medical…
EU guidelines A number of EU guidelines have been proposed for adoption or non-adoption by the TGA. These are now open for comment until 19 August 2013. The guidelines in question are listed below: Guideline on quality aspects on the isolation of candidate influenza vaccine viruses in cell culture. Guideline on the requirements for quality documentation…
In April 2013, the Australian Therapeutic Goods Administration released the first version of its much anticipated Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products. These requirements commenced on 31st May 2013 with a 12-month grace period requiring full compliance by 31st May 2014. Within…
TGA adoption of PIC/S GMP Guide for Medicinal Products Which version of the PIC/S GMP Guide does the TGA refer to? PIC/S Version 14, PIC/S Version 15, or PIC/S Version 16? PIC/S GMP Guide PE 009-15 (PIC/S Version 15) was published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S) in May 2021. This version (Version 15)…
TGA REFORMS – HISTORICAL DOCUMENT (blog originally published 21 May 2013): The TGA has released an exposure draft of a Regulation Impact Statement (RIS) on proposed changes to premarket assessment requirements for medical devices. The RIS is in response to the earlier consultation document on device reforms, released in January. The RIS provides details on…
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…
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….
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…
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