This blog highlights how we ensure PV Quality Assurance through comprehensive PV audits, vendor qualifications, and risk management strategies that are meticulously crafted to not only meet regulatory standards but also drive continuous improvement in pharmacovigilance operations.
In today’s highly regulated pharmaceutical landscape, the need for a robust Pharmacovigilance (PV) system is paramount. Lambda Therapeutic Research’s PV Quality Assurance framework focuses on optimizing safety processes, maintaining compliance, and ensuring patient safety through meticulous auditing. Here’s how our comprehensive PV audits, vendor qualifications, and risk management strategies are designed to meet regulatory standards while fostering continuous improvement.
PV System and Process Audits
Our PV audits focus on critical processes that form the foundation of a robust safety system. These include:
- XEVMPD: Ensuring compliance with the Extended EudraVigilance Medicinal Product Dictionary regulations.
- ICSR Management: Ensuring individual case safety reports (ICSRs) are correctly processed and submitted in compliance with global regulations.
- Literature Monitoring: Systematic review of medical and scientific literature to identify new safety signals or adverse events.
- Aggregate Reports: Oversight of periodic safety update reports (PSURs) and development safety update reports (DSURs).
- Risk Management Plan (RMP): Evaluation of risk minimization measures and their effectiveness.
- Signal Management: Detection, assessment, and mitigation of potential safety risks.
- Medical Information Call Center (MICC): Audit of call center processes to ensure that adverse events are properly identified and reported.
- Triage Process: Ensuring efficient classification and prioritization of incoming safety data.
- Pharmacovigilance System Master File (PSMF): Maintaining a comprehensive overview of the PV system.
Vendor Qualification and Re-qualification Audits:
Lambda conducts rigorous audits for vendor qualifications to ensure compliance with Good Pharmacovigilance Practices (GVP):
- QPPV and Local Responsible Person: Qualification and audit of Qualified Persons for Pharmacovigilance (QPPV) and local PV representatives.
- Local Literature Monitoring: Verification of regional literature monitoring systems for adverse event identification.
- Procurement of Full-Text Articles: Auditing the sourcing of full-text medical articles for accurate literature surveillance.
- Language Translation Vendors: Ensuring the reliability of vendors responsible for translating safety information.
MAH Affiliates and Business Partner Audits
We also audit Marketing Authorization Holders (MAHs) and business partners to ensure alignment with regulatory standards:
- Distributors and Marketing Partners: Assessing the compliance of distributors with PV requirements.
- Licensing Partners: Auditing the relationship between Reference Member State (RMS) and Concerned Member State (CMS) in the European Union.
- Affiliates/Local Offices: Evaluating the local implementation of global PV systems by affiliates.
CSV & IT Quality Assurance
Technology forms the backbone of modern PV systems, and Lambda ensures that IT vendors meet regulatory standards:
- Safety Database Vendors: Validating the systems used for managing safety data.
- Infrastructure and IT Service Providers: Auditing IT infrastructure for reliability, security, and compliance.
- IT Security and Data Backup Systems: Ensuring data security, backup, and disaster recovery measures are in place.
- GxP Systems Validation: Ensuring compliance of electronic systems with GxP (Good Practice) guidelines.
- Electronic Records/Signatures: Auditing systems for managing electronic records and signatures to ensure data integrity.
- Telecommunication Services: Ensuring that telecommunications systems used for PV are compliant and secure.
Inspection & Audit Readiness
Being prepared for external inspections is a vital aspect of any PV system. We expertly provide comprehensive support during audits and inspections, offering expert consultancy and tailored training to ensure readiness and compliance. Additionally, we conduct thorough pharmacovigilance gap analyses to identify any shortcomings in existing PV systems, followed by detailed recommendations for corrective actions to achieve full regulatory compliance.
Capabilities and Experience
With years of experience and a team of seasoned professionals, Lambda offers a robust PV Quality Assurance framework that spans from vendor audits to IT systems validation. Our deep understanding of regulatory requirements ensures that we provide comprehensive audit services designed to identify risks and implement effective corrective actions.
| Area of PV Auditing | Total Audit Experience |
|---|---|
| MAH affiliates/local offices | 53 |
| Licensing Partners (RMS-CMS relationship) | 13 |
| Distributors/Marketing Partners | 62 |
| PV System and Process Audits | 88 |
| Local Responsible Person and Literature Monitoring | 27 |
| CSV and IT | 17 |
| Telecommunication Service (MICC) | 3 |
| Translation/Full-Text Article Services | 4 |
Process Flow: PV Audits Management
Our audit process is designed to be systematic and comprehensive, ensuring no aspect of PV systems goes unchecked.
- Risk assessment with Key Risk factors
- Identification of key risk factors
- Risk-based approach for planning the audit
- Yearly assessment of key risk factors for prioritization and re-prioritization of Audits
- Audit Planning
- Strategic level audit planning results in an audit strategy (long-term approach)
- Tactical level audit planning in an audit programme, setting audit objectives
- Audit conduct
- Audit agenda
- Pre-audit document request
- Auditing
- Opening meeting
- Collecting information
- Audit findings
- Audit conclusion
- Closing meeting
- Audit Report
- Summarized the details in the designed form (i.e., Templates, checklist and framework)
- Audit observation details with its grading
- Audit communication and reporting
- Audit response and CAPA review
- CAPA tracking
- Follow up & Audit and CAPA closure
- Audit Certificate
Our PV Quality Assurance processes provide a structured, risk-based approach to auditing. Comprehensive Processes, ranging from vendor qualification to IT systems validation, ensure that our clients maintain compliance with global regulations while safeguarding patient safety. By leveraging our extensive experience and meticulous auditing practices, we help pharmaceutical companies maintain their commitment to the highest standards in pharmacovigilance.
Extensive Experience:
Lambda Therapeutic Research provides comprehensive drug safety & pharmacovigilance services, encompassing all clinical and post-marketing phases. Our well-established PV framework ensures thorough safety monitoring and regulatory compliance for both clinical and commercial products, offering end-to-end support across the entire life cycle of medicinal products.
