Our GVP Auditing Services

Good Pharmacovigilance Practice ensures that the safety of medicines is monitored throughout their lifecycle. Once a product is on the market, pharmacovigilance systems must detect, assess, understand, and prevent adverse effects. GVP audits verify that these systems are functioning correctly and that safety data is reliable. GxP Cellators provides GVP auditing services for marketing authorization holders, pharmacovigilance service providers, and companies with safety obligations. Our auditors understand the regulatory requirements and the practical realities of managing safety data at scale.

Global Regulatory Frameworks for GVP

EMA GVP Modules

The European Medicines Agency publishes Good Pharmacovigilance Practice modules that set out requirements for pharmacovigilance systems in the EU. Module I covers Pharmacovigilance systems and their quality systems. Module II covers Pharmacovigilance system master file. Module V covers Risk management systems. Module VI covers Collection, management and submission of reports. Module VIII covers Post authorization safety studies. Module IX covers Signal management. Module XV covers Safety communication. Module XVI covers Risk minimization measures.

Summary of Key EMA GVP Modules:

Module I: Pharmacovigilance systems and quality systems
Module II: Pharmacovigilance system master file
Module V: Risk management systems
Module VI: Collection and submission of reports
Module VIII: Post authorization safety studies
Module IX: Signal management
Module XV: Safety communication
Module XVI: Risk minimization measures

FDA Pharmacovigilance Requirements

The FDA regulates pharmacovigilance through requirements for postmarketing reporting of adverse drug experiences. 21 CFR 314.80 covers postmarketing reporting of adverse drug experiences. 21 CFR 314.98 covers postmarketing reports for approved applications. 21 CFR 600.80 covers biological products. Safety reporting timelines require 15 days for serious unexpected events. Periodic safety reports are required at defined intervals.

Summary of Key FDA Pharmacovigilance Requirements:

21 CFR 314.80 for postmarketing reporting
21 CFR 314.98 for postmarketing reports
21 CFR 600.80 for biological products
15 day reporting for serious unexpected
Periodic safety reports required

Health Canada Pharmacovigilance Requirements

Health Canada regulates pharmacovigilance through the Food and Drug Regulations and the Canada Vigilance Program. The Food and Drug Regulations cover post market reporting. The Canada Vigilance Program covers adverse reaction reporting. Risk management plans are required for certain products.

Summary of Key Health Canada Pharmacovigilance Requirements:

Food and Drug Regulations for post market reporting
Canada Vigilance Program for adverse reaction reporting
Risk management plans required

MHRA Pharmacovigilance Requirements

The MHRA regulates pharmacovigilance in the United Kingdom through UK specific requirements. UK pharmacovigilance requirements post Brexit include the Yellow Card Scheme for adverse reaction reporting, risk management plans, and periodic safety update reports.

Summary of Key MHRA Pharmacovigilance Requirements:

UK pharmacovigilance requirements post Brexit
Yellow Card Scheme for reporting
Risk management plans required
Periodic safety update reports required

WHO Pharmacovigilance Guidelines

The World Health Organization publishes pharmacovigilance guidelines that serve as an international reference. This includes the WHO Programme for International Drug Monitoring and guidelines on safety monitoring of medicinal products.

Summary of Key WHO Pharmacovigilance Guidelines:

International reference for pharmacovigilance
WHO Programme for International Drug Monitoring
Guidelines on safety monitoring

ICH Guidelines

The International Council for Harmonisation publishes guidelines that support pharmacovigilance activities. ICH E2A covers Clinical safety data management. ICH E2B covers Data elements for transmission of individual case safety reports. ICH E2C covers Periodic safety update reports. ICH E2D covers Post approval safety data management. ICH E2E covers Pharmacovigilance planning.

Summary of Key ICH Guidelines:

ICH E2A: Clinical safety data management
ICH E2B: Data elements for ICR transmission
ICH E2C: Periodic safety update reports
ICH E2D: Post approval safety data management
ICH E2E: Pharmacovigilance planning

Audit Types We Provide

Pharmacovigilance System Audits

We audit the overall pharmacovigilance system to verify that it meets regulatory requirements. This includes quality system for pharmacovigilance, organizational structure and responsibilities, personnel qualifications and training, standard operating procedures, documentation and record keeping, and compliance monitoring and CAPA.

Summary of Pharmacovigilance System Audits:

Quality system for pharmacovigilance
Organizational structure and responsibilities
Personnel qualifications and training
Standard operating procedures
Documentation and record keeping
Compliance monitoring and CAPA

Pharmacovigilance System Master File Audits

We audit the Pharmacovigilance System Master File to verify that it is complete and current. This includes PSMF content and maintenance, annexes and supporting documents, change control and version management, and availability to authorities upon request.

Summary of Pharmacovigilance System Master File Audits:

PSMF content and maintenance
Annexes and supporting documents
Change control and version management
Availability to authorities

Individual Case Safety Report Audits

We audit the processing and reporting of individual case safety reports. This includes case intake and data entry, case processing and medical review, coding and MedDRA terminology, follow up procedures, submission timelines and compliance, and electronic submission gateway compliance.

Summary of Individual Case Safety Report Audits:

Case intake and data entry
Case processing and medical review
Coding and MedDRA terminology
Follow up procedures
Submission timelines and compliance
Electronic submission gateway compliance

Signal Detection and Management Audits

We audit signal detection and management processes to verify that safety signals are identified and managed appropriately. This includes signal detection methodologies, signal validation and prioritization, signal assessment and evaluation, signal management documentation, and communication of safety signals.

Summary of Signal Detection and Management Audits:

Signal detection methodologies
Signal validation and prioritization
Signal assessment and evaluation
Signal management documentation
Communication of safety signals

Risk Management Plan Audits

We audit risk management plans to verify that they meet regulatory requirements. This includes RMP content and updates, safety specifications, pharmacovigilance plans, risk minimization measures, and effectiveness evaluation.

Summary of Risk Management Plan Audits:

RMP content and updates
Safety specifications
Pharmacovigilance plans
Risk minimization measures
Effectiveness evaluation

Periodic Safety Report Audits

We audit periodic safety reports to verify that they are complete and submitted on time. This includes PSUR/PBRER content and format, data analysis and benefit risk assessment, submission timelines, and regulatory authority responses.

Summary of Periodic Safety Report Audits:

PSUR/PBRER content and format
Data analysis and benefit risk assessment
Submission timelines
Regulatory authority responses

Post Authorization Safety Study Audits

We audit post authorization safety studies to verify that they are conducted according to protocol and regulatory requirements. This includes PASS protocol and design, study conduct and monitoring, data analysis and reporting, and publication and communication.

Summary of Post Authorization Safety Study Audits:

PASS protocol and design
Study conduct and monitoring
Data analysis and reporting
Publication and communication

Vendor and Service Provider Audits

We audit pharmacovigilance service providers to verify that they meet regulatory requirements. This includes PV service provider qualification, quality agreements and responsibilities, subcontractor management, and oversight and performance monitoring.

Summary of Vendor and Service Provider Audits:

PV service provider qualification
Quality agreements and responsibilities
Subcontractor management
Oversight and performance monitoring

Signal Detection Technology Audits

We audit the technology platforms used for signal detection and safety data management. This includes safety database validation, signal detection software validation, data mining methodologies, and access controls and audit trails.

Summary of Signal Detection Technology Audits:

Safety database validation
Signal detection software validation
Data mining methodologies
Access controls and audit trails

Who We Work With and Our Partners

Clients We Serve

We serve marketing authorization holders, pharmaceutical companies, biotechnology companies, pharmacovigilance service providers, contract research organizations, medical device companies, vaccines manufacturers, and generic drug companies.

Summary of Clients We Serve:

Marketing authorization holders
Pharmaceutical companies
Biotechnology companies
Pharmacovigilance service providers
Contract research organizations
Medical device companies
Vaccines manufacturers
Generic drug companies

Our Partners

We collaborate with pharmacovigilance software vendors, MedDRA and coding services, training providers, regulatory consultants, translation services, and medical writing services.

Summary of Our Partners:

Pharmacovigilance software vendors
MedDRA and coding services
Training providers
Regulatory consultants
Translation services
Medical writing services

Our GVP Audit Process

Phase	Activities	Output
Planning	Scope, PV system review	Audit plan
Document review	SOPs, PSMF, procedures	Pre audit analysis
On site	Interviews, system review	Working notes
Case review	ICSR sampling, data verification	Findings
Close out	Classification and CAPA discussion	Draft findings
Report	Final report with prioritized actions	Audit report
Follow up	CAPA verification and closure	Closure letter

Summary of GVP Audit Process:

Planning: scope, PV system review
Document review: SOPs, PSMF, procedures
On site: interviews, system review
Case review: ICSR sampling, data verification
Close out: classification and CAPA
Report: final report with prioritized actions
Follow up: CAPA verification and closure

Why Choose GxP Cellators for GVP Auditing

Auditors with pharmacovigilance and safety experience
Coverage of EMA GVP modules, FDA, Health Canada, MHRA, WHO, and ICH requirements
Strong focus on signal detection and risk management
Practical support for PSMF and RMP compliance
Reports designed for safety and quality teams
Full confidentiality for safety data

Summary of Why Choose GxP Cellators:

Auditors with pharmacovigilance experience
Coverage of EMA GVP modules, FDA, Health Canada, MHRA, WHO
Coverage of ICH requirements
Strong focus on signal detection
Practical support for PSMF and RMP
Reports for safety and quality teams
Full confidentiality

Contact Us for GVP Auditing Support

If you need to audit your pharmacovigilance system, assess signal detection, or prepare for an inspection, our GVP auditing team can help. Contact us to discuss your safety data and compliance needs.

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Source: GxP Cellators GxP Auditing page