Good Pharmacovigilance Practice (GVP) audit
Good Pharmacovigilance Practice, sometimes referred to as Good Vigilance Practice, involves the continual monitoring of drug safety and efficacy in use in the EU primarily. This includes collecting and analyzing data on adverse events and drug interactions, counterfeit drugs, drugs misuse/ abuse, as well as evaluating the effectiveness of drug use in different patient populations.
Scope of Good Pharmacovigilance Practice
Implemented as a regulatory requirement by European Medicine Agency (EMA) for the EU market, GVP compliance is required for any pharmaceutical companies that produce, sell pharmaceutical products such as vaccines, OTCs and general medicines.
GVP is adopted also by Canada. US FDA also shares GVP information from EMA to increase collaboration, but GVP is not a mandatory requirement in the States.
Requirements of Good Pharmacovigilance Practice
Designed to protect public’s health after new drugs entering the markets, GVP contains 16 Modules that cover different areas of vigilance on pharmaceutical products. In general, these Modules are around
- Identification fo safety signals
- Pharmacoepidemiologic assessment and safety signal interpretation
- Pharmacovigilance plan development
- Compliance with legal requirements
- Pharmacovigilance audits and risk management systems
- Collaboration and transparency
Good Pharmacovigilance Practice audit by Eurofins
As a regulatory requirement in the EU, pharmaceutical companies can work with Eurofins to run on-site GVP audit and show your compliance effectively. With our knowledge of other markets, we can deliver GVP audits that respond to the local regulatory requirements.
At the audit, our well-trained GVP auditors will conduct document review, interviews with laboratory personnel, and observe laboratory procedures to examine if there is any gaps between facility performance and GVP requirement. When the audit is completed, an audit report with detailed findings will be sent to the facilities, and facilities are expected to close any CAPAs.
Why choose Eurofins for your GVP audit?
We possess over 25 years of experience in the pharmaceutical and healthcare industry, supporting customers around the world on their compliance journeys. Our global network of auditors allows us to respond to your requests swiftly with travel costs and time minimised. As integrity and confidentiality matter, we uphold high level of impartiality in all the audit work we deliver.
In addition to on-site audit services, thanks to our expertise, we can deliver training and advisory services to better support customers who need extra help in reaching compliance goals. Shared GxP audits and purchase of GxP audit reports are both available online to offer fast and streamlined experience.
When working with us, our professional and customer-centric teams assist you along your GMV audit, and provide your GMP audit reports on time.
Auditing activities are compliant with EU, US, Canadian, Australian, Brazilian and Japanese regulation.
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