Challenges of Advanced Therapy Medicinal Products (ATMPs)
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Marketing Authorization Holders need to fulfil their responsibilities to perform regular risk-based audit(s) of their pharmacovigilance system (i.e. auditing of their affiliates and partners). In addition, vendor qualification audits need to be conducted on demand.
Our Pharmacovigilance audits obtain evidence and evaluate the evidence objectively to determine the extent to which the audit criteria are fulfilled and contribute to corrective and preventative actions (CAPA) ensure the improvement of risk management, control, and governance processes.
We apply our broad and long-term experience, as well as global network to fulfil the requested support regarding the planning Pharmacovigilance audits at various levels (strategic, tactical, and operational).
- Support for defining and implementing risk-based audit strategy / process
- PV System / Process gap analysis and pre-inspection support
- Conduct PV audits on behalf of the company:
- System audits at headquarter level
- Affiliate audits
- License partner and distributor audits
- Vendor and service provider audits
- Process and document audits (g. Pharmacovigilance System Master File (PSMF), Risk Management Plan (RMP), Periodic Safety Update Report (PSUR), QPPV Oversight)
- Prepare of audit plans, conduct of the audits and provision of detailed audit reports
- Provide flexible allocation of auditors based on annual audit program and risk-based audit strategy according to GVP requirements
- Ensure adherence to the annual audit program
- Conduct ad-hoc and triggered audits upon request
- Perform compliance monitoring and reporting to QPPV and QA department regarding timely CAPA implementation and audit results
- Support for implementation of company procedure(s) on auditing and CAPA management
- Support for follow-up activities of audits or Health Authorities inspections, i.e. the management of corrective and preventive actions (CAPAs)
PharmaLex offers customized Pharmacovigilance Auditing service based on audit scope and complexity:
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What our clients say
I just wanted to relay our sincere thanks to you and the team for two really excellent days training. It was well organized and structured to cover regulatory expectations, GMP principle and routine work challenges of industry. The presenters and moderator were highly skilled in this area to accommodate any queries raised during the training session and were well able to keep the team engaged even in remote/virtual training session. The design of training slides was impressive and the use of technology to make virtual training was remarkable.
Lorraine Henry
Compliance Lead, Qualified Person, Amneal Ireland Limited
Compliance Lead, Qualified Person, Amneal Ireland Limited
Rina and the team were brought in to help support us during the PMCPA complaint process and subsequent audits. Their expertise and approachability made this difficult process smooth. True professionals and a pleasure to work with!
Astellas
Head of Ethics and Compliance, Astellas Pharma Europe
Head of Ethics and Compliance, Astellas Pharma Europe