Quality Auditing & Surveillance
Remote Inspections / Distant Assessments
In light of the current travel restrictions and risk to public health posed by the COVID-19 pandemic, the HPRA initiated a process to conduct inspections remotely via distant assessment. The requirement to conduct a distant assessment will be determined on a case-by-case basis. Notifications will be sent in advance of the distant assessment in the same way as for an on-site inspection. The distant assessment process will, in general, follow a similar format to that for an on-site inspection and will commence with an opening meeting and conclude with a closing meeting via videoconference or alternative remote communication platform.
The communication platform used will be particularly important to facilitate the smooth running of the distant assessment. The sites hosting the distant assessment will be requested to propose a suitable communications platform and this will be agreed with the Inspector in advance of the distant assessment. The process will require electronic copies of documents and other information to be provided to the Inspector for review. Consideration should be given to the use of platforms which provide for live sharing of documents and videos, in addition to the use of cameras to allow for a virtual review of physical facilities, equipment and manufacturing operations, where applicable.
To avoid delays during distant assessment, companies will be requested to make certain documentation available prior to the commencement of the distant assessment. Documentation requirements will be specified in the pre-distant assessment notification. In certain circumstances, a distant assessment on its own may not be sufficient to enable a decision to be made regarding the level of compliance with GxP requirements and, as such, an on-site inspection may be performed at the earliest possible time. It is envisaged that this would generally focus on areas of the site that could not be inspected remotely and/or areas requiring further follow-up resulting from the distant assessment.
In certain circumstances, a hybrid approach may be adopted, in that a distant assessment and on-site inspection of limited duration are conducted in conjunction with each other. In these circumstances, COVID-19 protocols and associated arrangements will be discussed and agreed with the company in advance.
Companies can involve colleagues from within their wider organisation in the distant assessment but we would ask that they refrain from bringing international colleagues to the site to support the inspection.
About Quality Auditing and Surveillance
The HPRA carries out audits of medical device manufacturers on a regular basis. The type of audits that are conducted are as follows:
- Proactive post-market surveillance audits
- 'For cause' post-market surveillance audits
- Custom-made medical device audits
- Other audits pertaining to the register of medical devices
For more details on the type of audits please see:
The aim of these audits is to ensure that the medical device manufacturer is complying with the 'Essential Requirements' and schedules of the Medical Device Directives and related Statutory Instruments.
Another key area in which the HPRA is involved in is the surveillance of the medical device market to identify issues and trends in order to highlight priority areas for the medical devices market.
If you wish to obtain further information on auditing activities please contact a member of the audit team at email@example.com