GXP Solutions | Good Pharmacovigilance Practices (GVP)

What is a Good Pharmacovigilance Practices (GVP) Audit?

GVP Audits can be performed remote or on-site. Pharmacovigilance (PV) audits verify, by examination and evaluation of objective evidence, the appropriateness and effectiveness of the implementation and operation of a pharmacovigilance system, including its quality system for pharmacovigilance activities.

Purpose of GVP Auditing

The main goal of GVPs is to promote safe and effective medication. Most countries have their own agencies that lay out GVP regulation and ensure that all pharmaceutical companies comply with the practices. So, aside from ensuring the safety of products, GVPs are also important in complying with relevant rules and regulations.

Types of GVP Auditing

Business License Partner
PV LOC/Affiliate Audits
Service Provider/Vendor Audits
- Case processing
- Literature search
- Call center/Medical Information
- Translation
- Archiving
- Clinical safety activities at CROs
- Regulatory Intelligence Service
- Market Research/PAP/PSP
- Aggregate Reporting
- Specialty Pharmacies
Internal PV System and Process Audits
- SOP Management
- Training
- Pharmacovigilance System Master File (PSMF)
- Expanded Access Program
- Adverse Event Reporting
- Internal Aggregate Reporting
- Signal Detection
- PV Agreements
- Investigator Initiated Studies (IIS)
- Company core data sheet (CCDS) Development
- Reference Safety Information Systems (package insert, SmPC, etc.)
- REMS / Risk Management Plan (RMP)
- DSUR/PBRER
Animal Health PV
Clinical Drug Safety PV
PV Inspections (Include Agencies)
Medical Device Safety
PV Audits in Japan
Gap Analysis
QMS Projects

Importance of GVP Auditing

Good Pharmacovigilance Practices (GVPs) are a quality standard for monitoring the safety of medicines. GVPs are important for many reasons, including:

Promoting safe and effective medication: GVPs ensure that pharmaceutical products are safe and effective to use.
Complying with rules and regulations: GVPs are important for ensuring that pharmaceutical companies comply with relevant rules and regulations.
Protecting patients: GVP audits ensure that pharmaceutical companies adhere to regulatory requirements, continually assess drug safety, and take appropriate measures to protect patients from harm.
Improving the safety and efficacy of pharmaceutical products: GVP audits identify potential issues and improve the overall safety and efficacy of pharmaceutical products.