PV Audits and Training Services
PV audits are a systematic and independent examination to verify the suitability and efficacy of implementation and operation of a PV system, including its quality system. The US Food and Drug Administration (FDA) conducts pharmacovigilance audits to evaluate the quality of the pharmacovigilance activities of pharmaceutical companies. These audits are typically conducted as part of the FDA’s overall compliance and enforcement activities, and may be triggered by a variety of factors, such as adverse event reports, product recalls, or inspection findings.
With a more than a decade experience in working with global clients across USA, Canada, Japan, Europe and APAC, Techsol is a preferred PV audit service provider for many large and small pharmaceutical companies. We have completed over 100+ remote and on-site audits and we have served and maintained long-term relationships with 160+ clients.
Our global audit team with exposure and experiencing in supporting and being audited by global regulatory agencies, audits covering the whole PV system (case intake, adverse events processing and submission, project management, data management, QPPV role and responsibilities, aggregate report writing, signal and risk management, clinical safety, etc.).
How We Can Help
We help sponsor companies with the following types of pharmacovigilance audits.
> Independent PV Process Audits: We support our clients to conduct internal PV audits to assess their core pharmacovigilance processes, team capabilities, training, quality assurance, etc. to identify potential areas of non-compliance and areas for continous improvement.
> PV System Audits: These audits help sponsors to assess regulatory compliance (21 CFR Part 11, EU Annex 11, GDPR, etc.) and audit readiness of different software systems used across their PV business function.
> Mock inspections: Our PV Auditors can support sponsor companies to prepare for a regulatory inspection by conducting a mock audit with a comprehensive assessment of systems, data, people and processes as required by regulatory bodies.
> PV Process and Regulatory Training Services: We have PV domain experts who can deliver a personalized training on pharmacovigilance processes, latest regulatory requirements, procedures involved in agency interactions, best practices to avoid regulatory observations, findings and strategies to achieve, maintain and oversee compliance.
As part of our PV Auditing services, we perform a comprehensive quality, risk and compliance check to verify your organizations’ adherence to different regulatory bodies industry guidances and best practices.
These guidances provide recommendations and expectations for pharmaceutical companies, healthcare providers, and other stakeholders involved in pharmacovigilance activities related to drug safety monitoring, adverse event reporting, safety labeling, safety surveillance, product design, and regulatory submissions. It is always recommended to consult with the FDA website for the most up-to-date information on pharmacovigilance requirements and guidance.
European Medicines Agency (EMA)
- EudraVigilance Business Rules and Validation Procedures
- Guideline on Good Pharmacovigilance Practices (GVP)
- Module I: Pharmacovigilance systems and their quality management
- Module II: Pharmacovigilance system master files
- Module III: Pharmacovigilance inspections
- Module IV: Pharmacovigilance audits
- Module V: Risk management systems
- Module VI: Management and reporting of adverse reactions to medicinal products
- Module VII: Periodic safety update reports
- Module VIII: Post-authorisation safety studies
- Module IX: Signal management
- Module X: Additional monitoring
- Guidelines on Safety Reporting Requirements for Clinical Trials
- Pharmacovigilance Risk Assessment Committee (PRAC) Guidelines and Recommendations
United States Food and Drug Administration (FDA)
- Guidance for Industry: Postmarketing Adverse Event Reporting for Medical Products (2014)
- Guidance for Industry: Pharmacovigilance for Human Prescription Drug and Biological Products — Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling (2014)
- Guidance for Industry: Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff and Industry (2019)
- Guidance for Industry: Formal Dispute Resolution: Appeals Above the Division Level (2013)
- Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (2005)
- Guidance for Industry: Safety Considerations for Product Design to Minimize Medication Errors (2016)
- Guidance for Industry: Safety Reporting Requirements for INDs and BA/BE Studies (2020)
- Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Postmarketing Safety Reports (2021)
International Council for Harmonisation (ICH)
- E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting – provides definitions and reporting standards for adverse events that must be reported expediently.
- E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) – describes the requirements for electronic submission of individual case safety reports (ICSRs) for human pharmaceuticals.
- E2C(R2) Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs – provides guidance on the preparation and submission of periodic safety update reports (PSURs) for marketed drugs.
- E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) – includes requirements for pharmacovigilance and the management of safety data in clinical trials.
- M2(R2) Common Technical Document – provides guidance on the format and content of regulatory submissions for new drugs, including information on pharmacovigilance.
- E19 Optimization of Safety Data Collection – provides guidance on the optimization of safety data collection in clinical trials.
- E20 Development Safety Update Report (DSUR) – provides guidance on the preparation and submission of DSURs, which summarize the cumulative safety data for a drug during its development.
- E21 Pharmacogenomics – provides guidance on the use of pharmacogenomic data in drug development and pharmacovigilance.
- E22 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs – provides guidance on the evaluation of the potential for non-antiarrhythmic drugs to cause QT/QTc interval prolongation and cardiac arrhythmias.
- E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting – provides guidance on the reporting of adverse events for drugs that have been approved for marketing.
During a pharmacovigilance audit, the FDA may review a range of documents and data related to the company’s pharmacovigilance activities, such as:
- Standard operating procedures (SOPs) and work instructions related to pharmacovigilance
- Adverse event reports and related documentation, such as case processing forms and medical reviews
- Risk management plans (RMPs) and related documents
- Safety data exchange agreements (SDEAs) with partners or vendors
- Training records for pharmacovigilance personnel
- Inspection findings and corrective and preventive action (CAPA) plans
- Any other relevant documentation related to pharmacovigilance activities.
The FDA may also conduct interviews with pharmacovigilance personnel and other stakeholders to gather additional information and clarify any issues that arise during the audit.
The purpose of a pharmacovigilance audit is to assess the effectiveness of a company’s pharmacovigilance system and ensure compliance with relevant regulations and guidelines. The FDA may issue observations or warning letters based on the findings of the audit, and may require the company to take corrective action to address any deficiencies identified during the audit.
The European Medicines Agency (EMA) performs pharmacovigilance audits to ensure that marketing authorization holders (MAHs) and sponsors are complying with their pharmacovigilance obligations. These audits are conducted in accordance with the relevant European Union (EU) legislation, including the pharmacovigilance legislation and the good pharmacovigilance practices (GVP).
EMA conducts different types of audits, including:
Routine pharmacovigilance inspections: These are conducted to assess the quality and completeness of pharmacovigilance systems and processes implemented by MAHs and sponsors. These audits aim to ensure that MAHs and sponsors have effective pharmacovigilance systems in place to monitor and manage the safety of their medicinal products.
For-cause pharmacovigilance inspections: These are conducted in response to specific concerns or issues related to the safety of a medicinal product. These audits are triggered by factors such as safety signals, product quality issues, or complaints received from healthcare professionals or patients.
Follow-up pharmacovigilance inspections: These are conducted to assess the adequacy and effectiveness of corrective and preventive actions (CAPAs) taken by MAHs and sponsors following a previous pharmacovigilance inspection.
The frequency of these audits depends on the risk level of the medicinal product and the performance of the MAH or sponsor in meeting their pharmacovigilance obligations. High-risk medicinal products may be audited more frequently than low-risk products. Additionally, the frequency of audits may be increased if issues are identified during previous inspections or if there are concerns regarding the safety of a medicinal product
Performing a mock pharmacovigilance regulatory audit involves a thorough examination of a pharmaceutical company’s pharmacovigilance system to ensure compliance with regulatory requirements. Here are some of the activities we perform during a mock pharmacovigilance regulatory audit:
Plan the audit: Define the scope of the audit and identify the relevant regulatory requirements to be assessed. Determine the audit timeline and the resources required to complete the audit.
Review the pharmacovigilance system: Obtain and review the pharmacovigilance system documentation, including policies, procedures, and standard operating procedures. Evaluate the adequacy and effectiveness of the system and its compliance with regulatory requirements.
Conduct interviews: Interview relevant personnel, including the pharmacovigilance responsible person, the Qualified Person for Pharmacovigilance (QPPV), and other staff involved in pharmacovigilance activities. Gather information on how the pharmacovigilance system is implemented in practice.
Assess compliance: Evaluate the company’s compliance with regulatory requirements related to pharmacovigilance, such as signal detection, management of adverse events, and regulatory reporting obligations. Identify any areas of non-compliance and recommend corrective actions.
Draft a report: Prepare a report summarizing the findings of the audit, including any areas of non-compliance and recommendations for corrective actions. Provide a rating or a scorecard that reflects the overall performance of the pharmacovigilance system.
Follow up: Follow up with the company to ensure that corrective actions are implemented, and monitor their ongoing compliance with regulatory requirements.