Remote Pharmacovigilance Audits
Remote Pharmacovigilance Audits
- November 23, 2020
- Posted by: Manoj Swaminathan
In the past, Inspections/ audits were synonymous with ‘travel’- both domestic and International, but it is not the norm these days.
In 2020, when the Covid-19 crisis plagued the Pharmaceutical industry, many companies had to compromise on their annual audit plans and schedules. With the BCP measures in place, many companies were able to realize their audit plans, utilizing remote Pharmacovigilance audits. The Remote Audits are also termed as satellite audits or virtual or distant Pharmacovigilance audits.
In 2013, EMA had released the first version of ‘Distant/virtual pharmacovigilance inspections of MAHs during a crisis- Points to consider’, that states the following:
“Under situations such as transport restrictions or situations which give rise to concerns of inspectors’ safety (e.g. pandemics, natural disasters, high criminality areas), distant/virtual inspections could replace onsite inspections.”
Besides, MHRA recommends the following:
“Routine and triggered inspections may be conducted by inspectors remotely. These inspections are conducted through a review of requested documents, including evidence to support pharmacovigilance activities and submissions. The document review is supplemented with telephone interviews with relevant subject matter experts and written responses to specific queries. Logistical aspects of the Inspection, including timings and availability of specific subject matter experts and the QPPV for a telephone interview, are arranged with the inspected organization before the Inspection. An onsite inspection may be triggered following the remote Inspection, should any significant non-compliance or concerns that require further investigation be identified.”
Phases of Remote Pharmacovigilance Audit
2. Technical Preparation
3. Pre-Audit Documentation
4. Preparation – Audit Conduct
5. Audit Conduct, (Connection, Introductory meeting until Close-Out)
6. Reporting and Closure
Technical Preparation is the most critical aspect of a remote audit.
Various options include:
2. Web-based presentation – use of tools such as Webex, Skype, BlueJeans, Zoom, MS-Teams, and others.
4. Virtual Reality (at times used for facility rounds)
5. Combination methods
Some Regulatory Agencies also conduct technical testing 1-2 days before the Inspection, even if their or MAH’s Conferencing System is used during the Inspection.
Advantages of Remote Audit
1. Travel & Accommodation: Cost and time savings. No worries about procuring business/ short stay VISA. No Jet-lag issues
2. Multiple Auditee Sites can be considered at the same time. At times we can even have numerous auditors (and even SME) operating from different sites
3. Rescheduling is less cumbersome – No need to worry about flight cancellations
4. Recording the entire audit is possible (provided we have consented)
5. One can even consider 3-4 hours a day, spread out on multiple days. This is more common in case of Time-Zone issues
1. In my opinion, the greatest obstacle is concerning body language. Based on my experience as an auditor, ‘body language’ has been an essential factor for identifying potential gaps in the Pharmacovigilance Systems
2. At times auditee may lack focus as they may be doing multiple things at the same time, e.g., Checking E-Mails, attending a meeting or even phone calls
3. At times it may also be difficult to follow-up or deep-dive into potential issues identified during the audit
4. Data Integrity compliance may be difficult to assess, e.g., it may be difficult to distinguish between original documents and scanned printed document.
5. Reviewing multiple documents remotely may be a challenge
6. There may be too many pre-inspection/audit document requests
1. Technology – Last-minute IT issues, Internet and connectivity issues
2. May not be approved by some certification and accreditation bodies
3. Trust – At times, auditors develop trust only when it is an onsite one.
Caution to be Exercised (Auditees):
1. Giving access control to auditors
2. Recording audits without any consent
3. Don’t forget to train your team on the use of technology, discipline during the review and if possible, prepare a remote auditing guideline in advance
To conclude, remote audits may be a viable alternative to onsite inspections, although the results may not be comparable.
However, it may be a challenge for companies with not so strong IT departments or infrastructure.
Technical preparation may be a challenge and even cost accretive unless one has the option to lease out for a short duration.
For security reasons, the FDA uses its own IT platforms and equipment to host virtual interactions during remote inspections. As of April 2021, the FDA was using the following conferencing platforms:
• FDA Microsoft Teams
• FDA Zoom for Government
• FDA Adobe Connect
This may vary across regulators, and each may have their own preference.
For companies undertaking a remote audit of their partners, it is advisable to include a brief justification as to why they consider that instance of the remote review to be effective.
As far as regulatory authorities are concerned, one can even expect a surge in regulatory inspections, as an inspector can also consider inspecting more than one site on a single day.