EMA vs. FDA Virtual GCP Auditing Guidance: What You Need to Know

August 24, 2020

In response to the COVID-19 pandemic, global regulatory authorities adopted a pragmatic virtual auditing approach. This approach includes the flexibility and procedural simplifications to maintain clinical trial integrity and compliance to good clinical practice (GCP) requirements, while ensuring the safety of trial participants and staff.

Prior to COVID-19, despite the digital nature of today’s world, the move to remote GCP audits and inspections remained behind the curve due to confidentiality and credibility concerns. This is now rapidly changing.

EMA vs. FDA Virtual GCP Auditing Guidance: The Rising Need for Virtual Auditing

Today, increasingly more clinical trial participants are being positioned in various locations across the globe.  In addition, the number of Sponsors outsourcing what were previously considered core functions continues to increase.  As clinical trials continue to increase in complexity, the need for effective oversight by Sponsors is more crucial than ever before.  Further complicating the matter is the drive to contain pharmaceutical development costs, which can result in shrinking budgets, reduced resources, and increased employee workloads.

These factors, along with the COVID-19 crisis, have brought a new perspective toward virtual audits and inspections by life sciences firms.

Companies are now seeing firsthand that with cloud-based computing and storage, video conferencing, screen-sharing, as well as other IT advancements, remote audits can be an efficient and effective substitute for on-site audits.

EMA and FDA Clinical Trial Guidance During COVID-19

The European Medicines Agency (EMA) and Food and Drug Administration (FDA) recently published several guidance documents regarding the conduct of clinical trial monitoring, auditing, and inspections during this pandemic period. These guidance documents have allowed all of us who work under these regulations to adapt as well. ProPharma Group’s experienced consultants are able to instantaneously adjust to the virtual auditing model, providing our clients with continuous compliance support with the requirements for self-check and monitoring oversight of clinical trials.

Both EU and US guidance prioritize trial integrity, participant safety, and privacy and maintenance of data quality as key considerations when transitioning from on-site to remote. These guidance documents advocate the use of both on-site and centralized (remote) monitoring of investigational sites as part of the Sponsor’s oversight program.

The regulatory agencies have halted on-site clinical inspections for much of the duration of the outbreak. Clinical trial compliance checks are still required, and to make them feasible, authorities in the EU and US have moved to virtual inspections and assessments.

According to EU and US guidelines, virtual auditing may be applied to all types of clinical audits. The major exception to this approach is the investigator site remote audit, especially in Europe as the EMA considers them not feasible due to local legal requirements concerning accessibility and data protection. To overcome this restriction with investigator sites, ProPharma Group offers its clients a variety of experts geographically located throughout the EU who can provide more regional and on-site support. Similarly, the EMA is currently relying on the local competent authorities of member states to perform on-site inspections using a risk-based assessment.

In contrast, FDA has been performing clinical and investigator site inspections virtually for “mission critical inspections”, while postponing other less critical inspections. Therefore, Sponsors must always be inspection ready.

Furthermore, both EMA and FDA guidelines on remote auditing foresee an impact on planned audits, and recognize that any adaptation in the planning and conduct of audits should be aligned with a risk-based assessment where all decisions are duly documented as part of a prioritization strategy. By immediately activating ProPharma Group’s business continuity plans, our consultants enabled a smooth transition to this new worldwide landscape which allowed us to support our clients and meet their auditing commitments.

Reduce Your Inspection Risk with ProPharma Group

ProPharma Group’s auditing experts are experienced in designing audit strategies that incorporate flexibility with technology tools to exceed your expectations regarding the outcome of the virtual audit process. In addition, we know how important it is to maintain a quality management system, and we can offer a range of right-sized auditing services to meet your needs.

ProPharma Group’s consultants are ready to support your company and recommend alternative approaches to systems that have been impacted by the COVID-19 pandemic, such as remote audits for the short or long-term, ensuring independent and objective evaluation of the regulatory requirements are maintained. ProPharma Group experts can help identify gaps in your documentation and processes, create action plans to mitigate noted deficiencies, and ensure inspection readiness for whenever normal operations resume.

Once the pandemic is contained, we can provide a follow up on-site audit on a risk-based schedule. In addition to being cost efficient, the adapted schedule may also free your in-house resources for other tasks deemed critical during the period of the pandemic crisis.

To learn more about ProPharma Group’s virtual audit services, contact us today.



March 5, 2014

Ready for cGMP Validation: Gate Seven of the Nine Gate Transfer Process

Today, Bob Beall is back with the next gate in the Nine Gate Transfer Process. If you have missed any of the previous steps in this process, you can review them here: Gate 1: Assessment Gate 2:...

Ullustration showing transparent panels in a workflow

April 2, 2014

Process Validation: Gate Eight of the Nine Gate Transfer Process

Today we have the next phase of the Nine Gate Transfer Process: Gate 8 Process Validation. To review the previous steps before continuing, examine Gates 1-7 here: Gate 1: Assessment Gate 2:...

Post-Validation: Gate Nine of the Nine Gate Transfer Process

As the pharmaceutical supply chain evolves, at some point product/technology transfers will become part of the improvement process. When transferring production from site to site, an array of complex...