Overview:
During the duration of the COVID-19 pandemic, the TGA will only use remote and hybrid inspections to minimize potential impacts from an on-site inspection on industry staff while continuing governance of GMP at licensed domestic manufacturing sites. Routine on-site inspections will recommence at an appropriate time when the pandemic restrictions are lifted.
GMP Inspection Process:
The scope and inspection methodology will remain the same as on-site audit however, the time of the audit might have a longer timeline. If major/critical non-compliance are observed during the inspections the timelines may be extended or may even include an on-site component at a later date.
This process will utilize a risk-based model to evaluate the various options available for inspections on a case-by-case basis, in consultation with relevant staff at each specific manufacturing site.
There are no changes to GMP Clearance where current evidence is available. There is also no change to the existing MRA pathway and sponsors are encouraged to continue to submit their renewal applications using the existing evidence available.
Preparing for Remote inspection:
To prepare for a remote inspection the manufacturer should organize:
- 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.
- To make available for inspector’s use a guest remote read only logins for electronic systems for QMS databases such as complaints, deviations, OOS/OOT and other GMP relevant areas, when requested.
- The TGA will conduct the inspection in English. The manufacturer must have interpreters available.
- 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.
- Plan accordingly for time zone differences consideration to ensure subject matter experts should are made available at the pre-agreed timeslots.
- Prepare any information requested by inspector’s post-inspection should be provided by the manufacturer within the requested timeframes.
Regulatory Corner:
On July 1, 2020 New Manufacturing principles were adopted by the TGA the PIC/S Guide to GMP PE009-14.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations. To learn more, please contact us at info@globalregulatorypartners.com