Virtual (or Remote) QP Audits have become a key tool in supplier qualification and health authority inspection programs in the Pharma industry during the pandemic.

The regulatory authorities have published guidance on how they will perform their inspections by virtual/ remote audits or distant assessments during this restrictive period.

There are several elements to delivering a successful virtual audit.

Firstly, it is important to perform a risk assessment to assess the risks of postponing or performing a virtual audit as part of your supplier qualification or re-qualification program. The assessment should consider the compliance status, audit objectives, the available technology and complexity/accessibility of the processes used at the facility.

Audit Preparation:

Preparation is key to delivering a successful audit.  The agenda should be agreed well in advance including the scope of the audit, what documents will be shared prior to the audit and what documents will be shared during the audit, what IT platforms will be used, the timing of opening/closing meetings and interviews with SMEs and how the virtual facility tour will be handled. Ideally the virtual tour should be via real time video, but alternatives such as paper-based (slide deck describing the facility/equipment together photographs and plant layouts) or pre-recorded videos of the relevant areas and processes can also be used.  Allow sufficient time to complete the agenda. A benefit of virtual audits is that they do not need to be planned on consecutive days and can be planned over several part days if time zones or schedules do not allow full days.

It is important to test the IT platforms and broadband strength to ensure there are no glitches and that the auditor and auditee have full accessibility.

Regulations for Pharmaceuticals Post Brexit

Audit Execution:

If the audit is well planned, invites are issued in advance for all key meetings and expectations are clear for both parties, then the audit execution should flow well.

The opening and closing meetings should be held as normal but via the video conferencing tool selected.

The audit should be conducted as per the agreed agenda, allowing time for requested documents to be uploaded to the pre-defined shared drive. Remember that for organizations that have a paper-based system, consideration should be given to the practicalities of scanning and uploading records. Allow off-line time for the auditor to review the documents provided, and any questions or requests for additional information can be made remotely to the auditee. In some cases, documents may not be uploaded for review due to confidentiality issues, and in this case the documents can be viewed using a shared screen tool.

Audit Close and reporting for a virtual audit is the same as for an on-site audit.  The closing meeting should be used to provide immediate feedback to the audit team re the findings and allow time for clarification. The audit report should clearly document the process used to execute the remote audit, including the detail of how the virtual plant tour was facilitated as well as detailing the audit in sufficient detail to allow the reader to confirm the outcome of the audit.

For additional information please find references below;

http://www.hpra.ie/homepage/medicines/regulatory-information/manufacturers/inspections-relating-to-manufacturing-authorisations

https://www.ema.europa.eu/en/documents/scientific-guideline/guidance-related-gmp/gdp-pmf-distant-assessments_en.pdf

https://mhrainspectorate.blog.gov.uk/2020/03/23/mhra-good-practice-gxp-inspections-during-the-covid19-outbreak/

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/remote-interactive-evaluations-drug-manufacturing-and-bioresearch-monitoring-facilities-during-covid

If you would like to get in touch with MIAS Pharma, please email info@miaspharma.com or call us on +353 (1) 846 3605.