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 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.
So what is the TGA’s commitment?
The TGA has committed to meet the following timelines, subject to the co-operation of all parties.
|Application type outcomes||Measurement||Target timeframe|
|New Australian Licence Application||Application to Inspection Report||< 3 months|
|Variation to the scope, premises or conditions of licence (not requiring onsite assessment)||Application to Licence Issue||< 3 months|
|Re-inspection of Australian licensed premises||Inspection due date to Inspection report||< 6 months|
|GMP certificate or notarised copy of License||Application to Issue||< 15 working days|
|New Certificate of GMP Compliance – Initial inspection||Application to Inspection Report||< 6 months|
|Certificate of GMP Compliance – Re-inspection||Inspection due date to Inspection Report||< 6 months|
If any deficiencies are identified, the licence(s) will be withheld until there is a satisfactory resolution, again increasing the timeframe. The TGA have issued a list of these deficiencies that could hold up the issue of your licence, and you can read more about them at this blog.Each of these timeframes are measured from the time that the application is ‘effective’ and can be progressed by the TGA and assume that the sites are ready for inspection. If they are not ready, the application may be rejected meaning that the proposed timeframes could be extended.
Our advice is to take detailed minutes during the TGA GMP inspection, enter these deficiencies into your CAPA system and start working on the root cause, correcting the issue as soon as possible.
For more information, visit the TGA Website.
You might also be interested in these other blogs:
As a TGA GMP consultant, I’m often asked… “Do you have any examples of Critical and Major deficiencies?”
As a TGA GMP consultant, I’m often asked: “How frequently will I be inspected?”