Good Pharmacovigilance Practice (GVP) audits focus on ensuring that your Pharmacovigilance systems, including those of your suppliers, comply with industry regulations, keeping patient safety at the forefront.

Covered in GVP Audits:

Adverse Event Reporting:

Assessing systems for accurate and timely adverse event reports

Signal Detection:

Evaluate processes for identifying new safety signals.

Risk Management Plans (RMPs):

Ensure RMPs are properly implemented and monitored.

QMS for Pharmacovigilance:

Ensure that your Pharmacovigilance quality management systems comply with GVP standards.

Case Processing and Safety Reports:

Review all processes for case processing and preparation of safety reports.

PV System Master File:

Thoroughly audit master file to ensure completeness and compliance.

PV Agreements:

Ensure that Pharmacovigilance agreements with partners are compliant with regulations.

Good Pharmacovigilance Practice (GVP) Audit Approach

here’s how we handle your Good Pharmacovigilance Practice (GVP) audits:

Thorough Evaluation

We carefully check your Pharmacovigilance processes to make sure they follow global regulations and standards.

Adverse Event Checks

We review how you handle and report any adverse events to maintain patient safety and drug efficacy.

Signal Detection Review

We assess how you find and manage new safety signals and ensure they are streamlined and compliant with guidelines.

Risk Management Review

We examine your Risk Management Plans to see if they are effective and well-implemented.

Quality System Check

We assess your Quality Management System to make sure it supports good Pharmacovigilance practices and continuous improvement.

Regulatory Compliance

We check that you are following all relevant regulatory guidelines and standards.

Actionable Insights

We provide detailed reports with practical recommendations to help you improve any weak areas.

Through these steps, UMED ensures that your direct Pharmacovigilance practices or those of your suppliers are effective, compliant, and focused on keeping patients safe.