TGA GMP Insights: Forum Registrations Now Open

Registrations for the TGA GMP Forum on 19 – 20 November 2024 are now open. The Forum will be held at the Melbourne Convention & Exhibition Centre (MCEC). 

Members can Register for the Forum here

The ticket price is $690.00 (inc. GST) and includes a 2-day program, catering and a ticket to the Networking Night. Single day passes will not be offered. 

The TGA has published the draft program, providing delegates with an overview of the sessions to be held over the two days.  

Topics include the implementation of PIC/S version 16, the countdown to version 17 and Annex 1, TGA inspection trends, and other key reforms underway in GMP Clearance and Recalls.  

The GMP Forum is a fantastic opportunity to engage directly with the regulator outside of an inspection or evaluation. The Forum will be of interest to industry personnel involved in the manufacture and supply of medicines and biological products, including: 

  • Australian manufacturers and sponsors of complementary medicines; 
  • Medicine professionals in quality assurance, quality control, validation, regulatory affairs, and recall co-ordination roles; and 
  • Regulatory agents and consultants.  

Attendees will have the opportunity to connect and learn variety of plenary sessions, 
break-out sessions, workshops, exhibition stations and an evening networking event. 

Member Insight – TGA GMP Inspections; GMP Deficiencies 

TGA inspections continue via remote, hybrid and on-site means, however, more on-site inspections are being performed. The next parcel of overseas on-site inspections for 2024 is being finalised.  

TGA’s resumption of on-site inspections for China is currently being discussed in conjunction with DFAT. 

To speed up all inspections, the TGA are introducing surveillance inspections for some manufacturers as well as extending the validity of GMP certificates. Read more here

CMA is continuing discussions with TGA on practical implementation of Annex 16 for the complementary medicines industry, especially clause 1.4.2. Read more here

Since the beginning of the year, the following types of GMP deficiencies are being reported: 

Listed medicines  

  • Previously identified deficiencies are not being adequately addressed 
  • Data integrity issues 
  • Lack of analytical and microbiological validation of finished products 
  • PQR grouping not always justified, not conducted on time as per the procedure  
  • Some deviation investigations lack depth hence and the root cause is not determined 
  • Identification tests do not meet pharmacopeia monographs’ requirements 

Sterile and Non-sterile medicines (including Listed medicines) 

  • Failure to define GMP computerized systems and contract arrangements of computer service suppliers. 
  • Inadequate identification of cross-contamination and application of appropriate controls. 
  • The management of deviations and CAPAs are not fully effective. 

For feedback or questions on any of the above, please contact technical@cmaustralia.org.au .

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