FDA Pharmacovigilance Inspection Readiness Checklist | Expert Audit Preparation for 21 CFR 314 & 600
GPLACO Solutions provides expert consulting and advisory for FDA Pharmacovigilance inspection readiness references related to GVP (Good Pharmacovigilance Practices) audits, it’s important to understand that the U.S. Food and Drug Administration does not use the term “GVP” (that terminology is used by the European Medicines Agency).
In the US, pharmacovigilance inspections are conducted under FDA post-marketing safety regulations and related guidance documents.
Below are the key regulatory references you should use for FDA Pharmacovigilance Inspection Readiness Services for MAHs, Sponsors & CROs:
🔎 1️⃣ Core US Regulatory References (Post-Marketing Safety)
📘 21 CFR Part 314 – Drugs
21 CFR 314.80 – Postmarketing reporting of adverse drug experiences
21 CFR 314.81 – Other postmarketing reports
21 CFR 314.98 – Postmarketing reports for ANDAs
📘 21 CFR Part 600 – Biologics
21 CFR 600.80 – Postmarketing reporting of adverse experiences
21 CFR 600.90 – Waivers
These are the primary inspectional anchors during FDA PV inspections.
📘 2️⃣ FDA Pharmacovigilance Inspection Readiness Guidance Documents (Critical for Audit Readiness)
Issued by the U.S. Food and Drug Administration:
🔹 Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (2005)
Foundational PV framework in the US.
🔹 Safety Reporting Requirements for INDs and BA/BE Studies
(IND Safety Reporting – 21 CFR 312.32)
🔹 Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines
🔹 Pharmacovigilance Planning
US equivalent concept to EU Risk Management Plans.
🏛 3️⃣ Risk Evaluation & REMS Oversight
📘 21 CFR 314 Subpart I – REMS
Risk Evaluation and Mitigation Strategies
Frequently inspected during FDA PV audits
📑 4️⃣ FDA Inspection & Compliance References
📗 FDA Investigations Operations Manual (IOM)
Used by FDA inspectors during inspections.
📗 FDA Compliance Program Guidance Manual (CPGM)
7348.001 – Postmarketing Adverse Drug Experience Reporting
Primary program used for PV inspections.
🧾 5️⃣ Electronic Reporting Requirements
FAERS (FDA Adverse Event Reporting System)
E2B(R3) format compliance
ESG submission requirements
Here is a comprehensive FDA Pharmacovigilance (PV) Inspection Readiness Checklist aligned with:
U.S. Food and Drug Administration
21 CFR 314.80 / 314.81
21 CFR 600.80
21 CFR 312.32
Compliance Program CPGM 7348.001
✅ FDA PV INSPECTION READINESS CHECKLIST
1️⃣ Governance & Oversight
☐ Defined Pharmacovigilance System
☐ Safety organizational chart
☐ Clear roles & responsibilities
☐ US Agent (if applicable)
☐ Safety governance committee minutes
☐ Management oversight documentation
FDA focus: Who is accountable? How is compliance monitored?
2️⃣ SOPs & Procedures
☐ Global & US-specific PV SOPs
☐ SAE intake and triage process
☐ 15-day Alert reporting SOP
☐ Periodic reporting SOP (PADER)
☐ Literature screening SOP
☐ Signal detection process
☐ REMS management SOP (if applicable)
☐ Vendor oversight SOP
☐ Audit & CAPA management SOP
FDA focus: Are procedures actually followed or just documented?
3️⃣ ICSR Management (21 CFR 314.80 / 600.80)
☐ 15-calendar-day reporting compliance
☐ 30-day follow-up compliance
☐ Duplicate detection process
☐ MedDRA coding quality checks
☐ Narrative medical review documentation
☐ Case quality review process
☐ E2B(R3) compliance
☐ Submission confirmation (ESG receipts)
☐ Reconciliation (clinical, partners, vendors)
FDA focus: Timeliness, completeness, accuracy.
4️⃣ IND Safety Reporting (21 CFR 312.32)
☐ Unexpected serious suspected adverse reactions
☐ 7-day fatal/life-threatening reporting
☐ Unblinding procedures
☐ Aggregate safety evaluation
☐ Data Monitoring Committee oversight
5️⃣ Aggregate Reporting
☐ PADER (Periodic Adverse Drug Experience Reports)
☐ Line listings accuracy
☐ 15-day cases properly included/excluded
☐ Regulatory submission tracking
☐ Benefit-risk evaluation documentation
6️⃣ Signal Detection & Risk Management
☐ Signal detection methodology documented
☐ Frequency of review defined
☐ Statistical tools validation
☐ Signal tracking log
☐ Safety review meeting minutes
☐ Escalation process
☐ Label change decision documentation
FDA focus: Proactive vs reactive system.
7️⃣ REMS (If Applicable)
☐ REMS program documentation
☐ Timely REMS assessment submissions
☐ REMS vendor oversight
☐ REMS audit trail
☐ REMS communication materials
8️⃣ Vendor Oversight
☐ Safety Data Exchange Agreements (SDEA)
☐ Defined reporting timelines
☐ Vendor KPIs
☐ Vendor audit reports
☐ Oversight meeting minutes
☐ Reconciliation documentation
FDA focus: You remain responsible even if outsourced.
9️⃣ Data Integrity & Systems
☐ Validated safety database
☐ Access controls
☐ Audit trail review process
☐ Backup & disaster recovery plan
☐ Change control documentation
☐ Periodic system validation
🔟 Training & Compliance
☐ PV training matrix
☐ Training records
☐ Investigator safety reporting training
☐ Refresher training frequency
☐ Audit findings & CAPA closure
1️⃣1️⃣ Inspection Readiness Logistics
☐ Designated inspection lead
☐ Back-room support team
☐ Document control room setup
☐ SME availability
☐ Mock inspection conducted
☐ Inspection playbook prepared
🚨 Top 10 FDA 483 Risk Areas
Late 15-day reports
Inadequate follow-up attempts
Missing literature cases
Poor signal documentation
Lack of medical review documentation
REMS non-compliance
Vendor oversight gaps
Reconciliation failures
Incomplete audit trails
No documented trend analysis