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News & Press: News

Impact Statement Australian Therapeutic Goods Administration (TGA) – Remote inspections

16 July 2020   (0 Comments)
Posted by: Tamsin Marshall
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Background

Following the suspension of on-site inspections during the COVID -19 pandemic, TGA developed new arrangements to allow continued and flexible oversight of licenced domestic manufacturers by performing remote GMP inspections.
The domestic program demonstrated that it would be possible to replicate this approach for overseas medicine and biological manufacturers. However, it is recognised that broadening this program may bring additional challenges and the same number of manufacturers cannot be inspected using this approach.

 

Timing

From July 2020, TGA will begin the remote GMP inspections program for some overseas manufacturers.
Sponsors who have submitted Certification (CE) applications or whose manufacturer has been identified as requiring a remote GMP inspection will be contacted to register their interest in participating.

 

Specific Requirements

In the past companies have at times found the remote inspection process somewhat onerous and with a greater potential for misunderstandings arising than during a conventional on-site inspection. TGA has set out certain requirements for a designated “Remote inspection host” and for “remote inspection preparation”

 

Remote inspection host

An authorised responsible person should be nominated by the manufacturer to be the Remote Inspection Host. This authorised person must have the required authority and IT support to ensure a smooth remote inspection process can take place.


TGA Inspection staff will use the Remote Inspection Host as their point of contact for all communication in relation to the remote inspection for the site.


The TGA will send a pre-inspection checklist to the manufacturing site, to be completed by the Remote Inspection Host within 2 weeks of receipt of the document. This checklist will assist in determining if an overseas manufacturing site is ready for a remote inspection and will enable the manufacturer to commence preparation for the remote inspection.


The Remote Inspection Host must return the pre-inspection checklist requested documentation in the timeframes set by the Lead Inspector. These documents must be available in an electronic 'read only' format and in English.

 

Remote inspection preparation

To prepare for a remote inspection the manufacturer should organise to have pre-recorded videos of the site and operations so that the inspectors can be presented with a virtual tour of GMP relevant areas.


If the manufacturer has electronic systems for QMS databases such as complaints, deviations, OOS/OOT and other GMP relevant areas then it is requested to organise guest remote read only logins to the QMS databases for inspectors’ use at the time of inspection.


The TGA will conduct the inspection in English. The manufacturer must have interpreters available, for each inspector on the Inspection Team, who have both excellent technical knowledge and English skills.


The manufacturer must have the ability to participate in and/or host virtual communication on a suitable and agreed IT platform, with timely IT support during the remote inspection. This should include the ability to live stream video if required.


Where time zone differences need to be taken into consideration staff including subject matter experts should be made available at the pre-agreed real-time communication timeslots.


The manufacturer should address any other requests during the remote inspection in a timely manner to ensure a smooth process flow.


Any information requested by inspector’s post-inspection should be provided by the manufacturer within the requested timeframes.
See:- https://www.tga.gov.au/gmp-approach-overseas-manufacturers-medicines-and-biologicals-during-covid-19-pandemic and https://www.tga.gov.au/tga-expectations-overseas-manufacturing-sites-hosting-remote-inspections-during-covid-19-pandemic


PHSS Observation

As usual from TGA a very clear definition of their requirements. Companies may however find some of the requirements quite challenging / onerous.
During the current pandemic, the likely hood of remote inspections is liable to increase and if found successful could be adopted as more of a routine than we are used to at the moment.


As we all become more used to remote working, companies may also begin adopting such practices for their internal and supplier GMP audits.


BE PREPARED

 

Click here to download document
Prepared by Malcolm Holmes (PHSS Management Committee Regulatory Specialist)
15th July 2020


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