BY SIEGFRIED SCHMITT, VICE PRESIDENT – TECHNICAL, REGULATORY & ACCESS, PAREXEL
As global regulatory agencies are preparing to return to on-site inspections1, industry needs to be ready. With the continued threat of COVID-19, the way inspections will be performed and hosted will be significantly different from the pre-pandemic situation. In most cases, Inspections are expected to be a combination of on-site activities and virtual assessments, where inspectors may communicate with staff partly face-to-face and via electronic media, facilities will get looked at in person and also via photographic or video means. As already experienced, some inspectors may be on site, whilst others may participate remotely.
In some instances, access within the facilities is restricted (following government and company rules for distancing) and international travel is also curtailed, which makes it difficult for inspectors to be physically present during an inspection. Some agencies have therefore published guidance that details their expectations of the site2, which includes pre-recorded videos of the site and operations, and remote read-only logins to the QMS databases for inspectors’ use, to name but a few.
These remote inspections are not entirely comparable with “paper audits”, they are in fact much more demanding as they make maximum use of electronic tools. Few companies have had experience yet with such preparations, or even going through an actual inspection. It is extremely beneficial to learn from the experience of those few, e.g. what went well and where did the unexpected happen? For example, delays due to low bandwidth could be interpreted as wilfully slowing (i.e. delaying) the inspection.
Preparing for the new reality
This is new territory, and some companies may not be prepared from a procedural and a technical standpoint. Companies will need to consider how to host these inspections and identify secure and capable communication and data exchange tools.
As with all inspections, we must consider people, processes, documented evidence and technology. Staff will be trained in answering inspectors’ questions in face-to-face situations but may demonstrate different behaviour when interacting via video link. It is a new situation and it requires a lot of practice. For example, important nonverbal cues may be missed, or one may not be able to see what documents the inspector is looking at, whilst being questioned. There may be additional requirements to work outside normal working hours to accommodate the inspectors’ time zone.
The traditional setup with front and back office will likely be challenged as not all staff can be on site or work close together (as was standard practice). The normal process of photocopying documents will change to scanned documents and making them available through shared repositories. This can be a significant task, e.g. when large files like executed batch records have to be scanned. Much more information will have to shared electronically prior to the inspection (transmittal of files - watermarked as confidential), during the inspection (direct access for the inspectors) and post inspection (there is no longer a “the inspectors have left the site” situation). It is the responsibility of the inspected company to provide the technology that enables the inspection and there is no harmonisation amongst the agencies (one video platform may work for one agency, but not another).
Expertise to help you succeed
Parexel has developed tried and tested methodologies for scenarios that range from entirely virtual (desktop) inspections, hybrid models and for completely on-site visits. Our services include:
- Quality System Reviews: challenging the procedures and processes for adequacy and compliance
- Training in behaviour and execution: presenting in person or via telecommunication are very different
- Performing mock inspections (from completely remote to hybrid to full on-site): challenging the technological means, the behaviour under social distancing rules, the responsiveness of staff and the quality of data and information provided
We help companies implement the most current industry best practices. Our consulting services are delivered by 1000+ consulting experts, including 80+ former regulators/inspectors on staff from FDA, MHRA, EMA and NMPA.
Prepare for success, be ready for the “new normal”.