Good Pharmacovigilance Practice (GVP) Audit
Pharmacovigilance regulations mandate Marketing Authorisation Holders (MAHs) to conduct audits of their pharmacovigilance systems, incorporating risk-based assessments of their quality frameworks.
As outlined in Good Pharmacovigilance Practice (GVP) Module I, a GVP audit is a structured, rigorous, independent and documented process aimed at gathering and objectively evaluating evidence to determine the fulfilment of audit criteria. This process contributes to enhancing risk management, control and governance procedures.
Pharmacovigilance audit tasks involve scrutinising the implementation and operation of a pharmacovigilance system, including its quality framework for pharmacovigilance activities, by assessing objective evidence.
If you’re looking to outsource your GVP audits, we are a trusted partner with a track record of conducting audits for numerous domestic and international clients.
Trusted by top-tier teams worldwide
Our Good Pharmacovigilance Practice auditing services include:
- Pharmacovigilance system audits
- Partners and distributors
- Medical Information
- Call centres
- Market Research Programmes (MRP)
- Patient Support Programmes (PSP)
- Compassionate Use Programmes (CUP)
- Speciality pharmacy
- Risk Evaluation Mitigation Strategies (REMS)
- Qualified Person for Pharmacovigilance (QPPV) and Local Safety Officers (LSO)
- Affiliates and local operating companies
- Internal process
- Patient support programmes
- Post-Authorisation Safety Studies (PASS)
Our Global Reach
We take pride in our extensive global audit network and are committed to utilising local auditors based in-country.
This approach offers several key benefits: local auditors possess in-depth knowledge of regional regulations, communicate effectively in the local language, and help reduce travel expenses for our clients. We have successfully provided support in all the regions highlighted on the map below.
FAQs on Audits
We provide a modern approach to auditing that offers full transparency. We aim to make the process as simple to understand as possible and are always on hand to answer any questions you might have.
Here are some of the questions we get asked most often.
Yes, our team can provide comprehensive CAPA (Corrective and Preventive Action) Management support.
Our modern and flexible approach ensures effective handling of CAPA processes, helping not only address and prevent any non-conformities but also contribute towards the continual improvement of both quality and compliance.
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