PHARMALANE UK stands out for its unwavering commitment to quality and excellence in pharmacovigilance. Our commitment to patient safety and regulatory compliance is unbeatable. As a part of our dedication to maintaining the highest standards of pharmacovigilance, we conduct thorough Good Pharmacovigilance Practices (GPvP) audit Services for our clients.
Our GPvP audit services cover a wide range of activities, including comprehensive evaluations of pharmacovigilance systems and thorough assessments of the site against the regulatory requirements. Drawing on our extensive industry expertise and global expertise, we offer valuable insights that promote ongoing enhancement. Our team of experienced professionals is dedicated to conducting rigorous audits that surpass industry standards, ensuring that our clients’ pharmacovigilance systems are both resilient and effective.
COMPLIANCE AUDIT: To verify that pharmacovigilance practices and processes comply with regulatory requirements and industry standards. Review adherence to local and global regulations, such as ICH E2E, GVP guidelines, and specific regional requirements.
SYSTEM AUDIT: Evaluate the overall effectiveness and robustness of the pharmacovigilance system. Assess data management, risk assessment procedures, signal detection, and reporting
PV SYSTEMS AND PROCESS AUDITS: Auditing critical areas such as the Qualified Person for Pharmacovigilance (QPPV) and Local Responsible Person (LRP) roles, global safety databases, case management for SUSARs and ICSRs. Our services also include thorough assessments of aggregate reporting processes for PSURs and DSURs, as well as risk management, signal detection, and medical coding.
THIRD-PARTY AUDITS: Auditing commercial partners, service providers, and other vendors are also offered; our consultancy services extend to audit program management, risk-based audit planning, inspection readiness training, and mock inspections. We conduct gap analyses, support QMS development, and manage CAPA (Corrective and Preventive Actions) and EC (Escalation) processes to ensure your systems are fully prepared and compliant.
PROCESS AUDIT: Examine specific pharmacovigilance processes and their efficiency. Focus on processes such as adverse event reporting, data entry and processing, and case management.
VENDOR AUDIT: Assess the pharmacovigilance practices of third-party vendors or service providers. Ensuring that outsourced pharmacovigilance activities are compliant with the company’s standards and regulatory requirements.
REGULATORY INSPECTION PREPARATION AUDIT: Prepare a company for an upcoming regulatory inspection by identifying potential issues and ensuring readiness. This includes mock inspections and comprehensive reviews to address any gaps before an actual regulatory inspection.
PERIODIC AUDIT: Provide ongoing assurance that pharmacovigilance practices remain effective and compliant over time. This can be conducted at regular intervals to review and update pharmacovigilance practices and systems.
So, what are you waiting for, please contact us now for any of the related support you may need and we are happy to help!
Our Audit Report Package is very thorough and includes all of the following which is sufficient enough to qualify the supplier: