3 Parts of a Comprehensive GCP Quality Audit

Independent evaluations of activities, processes and products are essential to any organization concerned with quality management, especially those involved with pharmaceuticals and drug development.

When it comes to clinical research, independent GCP audits provide an important glimpse into the quality of the research being conducted while assessing the effectiveness of the standard operating procedures guiding your work.

Clinical trial audits are typically carried by a team of specialist consultants from an independent third party sponsor to ensure objectivity in the audit’s two main goals:

1. Making sure the rights of your trial subjects are respected throughout the process, and
2. Ensuring all data gathered during the trial is reliable

Audits of clinical trials can be performed at any phase of the trial, even during development.

A thorough GCP Audit is typically broken into three distinct parts:

1: Auditing investigator sites participating in the clinical trial

This kind of auditing accomplishes two things:

1. Identifying site-specific problems that can be addressed on a case-by-case basis, and
2. Highlighting systemic issues that can damage the quality of the trial as a whole

Whether issues are small and localized or large and systemic, both can throw the results of a clinical trial into question. Taking a representative sample audit of investigator sites can prompt both corrective and preventative actions to fix any issues before they impact the quality of your results.

2: Auditing third party service providers

Sometimes those you outsource to end up outsourcing the work to others when it falls outside their area of expertise. Since you’re ultimately responsible for the quality of the clinical trial you conduct, ensuring your network of service providers is adhering to rigorous standards is crucial.

Routine audits of service providers by an independent team make certain those you’re leveraging are meeting the standards needed to comply with regulatory requirements.

3: Auditing specific systems

Similar to how a site audit can hone in on a specific investigator site, a systems audit can assess whether a particular activity is compliant.

Even when a specific system is meeting all requirements, an audit can reveal areas of improvement in order to streamline processes and procedures.

A comprehensive systems audit reviews the standard operating procedures currently in use, compiles information from those implementing the procedures and samples the data being collected to make sure the system is compliant.

What happens following a GCP Quality Audit?

After an audit is completed, an in-depth report is compiled detailing all of the observations collected during the assessment.

Your auditor will then put together a corrective and preventative action plan (CAPA) which clearly outlines a timeline for actions and a list of those responsible for carrying them out.

Things to keep in mind when working with an independent FDA compliance consulting and auditing service:

1. Audits are a snapshot, not a full report of your trial from beginning to end. While GCP and other GxP audits are essential for ensuring quality, they should be one part of a larger quality management process.
2. If you’ve planned audits into your trial, you may be required to prove you completed them. Audits usually aren’t requested by regulatory inspectors, but if you’ve planned them into your clinical trial, you may need to provide evidence that they were completed.
3. Audits are becoming increasingly complicated. As clinical trials increasingly use investigator sites located outside of the United States, auditors are facing steep challenges to make sure these remote audits are thorough and reliable. Work with a regulatory and compliance service that has the global reach capable of handling GCP audits worldwide.

Want to learn more about GxP Auditing? Click here to read our free whitepaper: GxP Audits Overview.

Looking for a GxP auditing and remediation service with intimate knowledge of the FDA’s current inspection techniques and expectations? We provide comprehensive FDA compliance consulting, auditing and remediation support to ensure no significant FDA-483 observations or Warning Letters are issued by the FDA.

Click here to learn more about our GxP Auditing and Remediation services or contact us today to get started.