GVP Pharmacovigilance Audits & Due Diligence for MAHs, Sponsors and CROs

Why Vendor Qualification, PV QMS, and Pre-Outsourcing Readiness Decide Regulatory Outcomes

Who this is for:

• A Marketing Authorisation Holder (MAH)

• A Sponsor outsourcing pharmacovigilance

• A Biotech scaling globally

• Preparing for FDA, EMA, MHRA, TGA inspections

👉 Engage GPLACO SOLUTIONS for risk-based GVP audits and PV due diligence that regulators appreciate.

Why GVP Pharmacovigilance Audits Are No Longer Optional

Regulators no longer ask whether you outsourced pharmacovigilance.
They ask:

• How did you qualify the vendor?

• How do you control them?

• Can you prove ongoing oversight?

Under:

• EU GVP Module I & IV

• FDA 21 CFR 314 / 600

• MHRA PV inspections

• TGA & APAC regulatory frameworks

👉 The MAH remains fully accountable, even if 100% of PV is outsourced.

This is where GVP audits and due diligence become business-critical.

Vendor Qualification: The #1 Failure Point in PV Inspections

Most critical inspection findings stem from poor vendor qualification, not poor vendors.

Regulators expect evidence of:

• Risk-based vendor selection

• Documented qualification audits

• Defined PV responsibilities

• Ongoing performance monitoring

Common regulatory findings:

• “Vendor audit not performed prior to outsourcing”

• “No documented vendor qualification rationale”

• “Inadequate oversight of third-party PV activities”

How to Choose the Right Pharmacovigilance Vendor (Regulatory View)

Forget marketing brochures. Regulators look for proof, not promises.

Key vendor qualification criteria:

• Proven experience with US FDA / EMA / MHRA

• Clear understanding of GVP Modules

• Robust PV QMS

• Inspection history and CAPA maturity

• Scalable operations across regions (EU, US, APAC)

Critical question regulators silently ask:

“Would this vendor survive an inspection without the MAH stepping in?”

If the answer is no — you carry the risk.

GVP Audits: What Authorities Expect to See

Types of PV audits regulators expect:

• Vendor qualification audits

• Routine oversight audits

• For-cause audits

• Pre-inspection readiness audits

Audit scope must cover:

• ICSR intake, triage, processing, and submissions

• Signal detection & management

• Risk Management Plans (RMPs)

• Aggregate reporting (PSUR / PBRER / DSUR)

• Data integrity & compliance controls

A checkbox audit fails. Risk-based audits pass.

Establishing a Robust PV QMS (Local & Global)

A PV QMS is not documentation — it is governance.

Regulators expect:

• Clear SOP hierarchy (Global → Regional → Local)

• Defined MAH vs Vendor responsibilities

• Escalation pathways

• Deviation & CAPA management

• Inspection readiness built into daily operations

For global organizations:

• Local QMS must align with global standards

• Country-specific deviations must be justified

• Vendor SOPs must map to MAH SOPs

👉 If SOPs exist only “for audit”, inspectors will find it.

Before Outsourcing PV: Regulatory Due Diligence Checklist

This is where most organizations fail before outsourcing.

Pre-outsourcing PV checklist (inspection-ready):

Governance

• Defined MAH accountability

• PV System Master File (PSMF) impact assessment

• Qualified Person for Pharmacovigilance (QPPV) alignment

Vendor Readiness

• Completed qualification audit

• Risk classification of vendor activities

• Inspection history review

Contracts & Agreements

• PV Agreement aligned with GVP Module I

• Clear safety data exchange timelines

• Escalation & breach management clauses

Operational Controls

• Oversight KPIs and metrics

• Quality review mechanisms

• Business continuity & disaster recovery

Documentation

• Audit reports and CAPAs

• SOP mappings

• Training records

If this checklist is incomplete, do not outsource yet.

Due Diligence for M&A, Licensing, and Asset Acquisition

PV due diligence is now a deal-breaker.

Regulators and investors assess:

• Historical compliance risks

• Open CAPAs and unresolved findings

• Vendor dependency risks

• Inspection exposure post-acquisition

A weak PV system can:

• Delay deal closure

• Reduce asset valuation

• Trigger post-approval commitments

Why Organizations Engage GPLACO SOLUTIONS

At GPLACO SOLUTIONS, we do not sell templates — we build inspection-proof systems.

Our GVP audit & due diligence expertise includes:

• 200+ global PV & GVP audits delivered

• MAH, vendor, and partner audits

• FDA, EMA, MHRA, TGA aligned frameworks

• Risk-based vendor qualification models

• PV QMS design for global and APAC operations

Outcome:
✔ Zero critical findings
✔ Regulatory-defensible oversight
✔ Confident outsourcing decisions

When Should You Act?

You need GVP audit & due diligence support if:

• You are outsourcing PV

• You manage multiple vendors

• You are preparing for inspection

• You are entering new markets

• You are undergoing M&A or licensing

Waiting until inspection notice is already too late.

👉 Engage GPLACO SOLUTIONS for risk-based GVP audits and PV due diligence that regulators respect.