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TGA expectations for overseas manufacturing sites hosting remote inspections during the COVID-19 pandemic
The COVID-19 pandemic has had a significant impact on regulatory bodies and business organisations around the world. Travel restrictions and ensuring a safe working environment for all staff currently prevents face-to-face on-site overseas GMP inspections from being conducted.
Industry and regulatory bodies need to work together to help maintain appropriate regulatory oversight of GMP activities to ensure the continued quality, safety efficacy and continuity of supply of therapeutic products and services to protect patients.
Following the publication of the GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic, below is further information designed to assist manufacturers who may undergo a remote inspection.
The TGA expects all organisations manufacturing therapeutic goods to maintain GMP compliance to ensure the ongoing protection of public health.
Manufacturers have the responsibility of ensuring an effective Quality Management System (QMS) is in place and adequately resourced, taking into account any impacts from the pandemic. The QMS should be reviewed using risk management principles in order to identify any hazards from the direct or indirect impact of the pandemic and implement a risk management plan to mitigate or minimise any identified risks.
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 inspectors post-inspection should be provided by the manufacturer within the requested timeframes.