What the QP Actually Does

In EU/UK clinical trials, a QP isn’t a formality—they’re the legal authority who certifies that each batch of IMP meets GMP standards and matches what’s documented in the regulatory file. Without their approval, product doesn’t move. Simple as that.

Their role extends well beyond batch sign-off. The QP:

• Verifies GMP compliance: Every document, from batch records to CoAs, must be reviewed and reconciled before product release.

• Certifies each batch: If even one data point is off, the QP has the power—and obligation—to hold the batch.

• Conducts audits and oversight: Vendors, manufacturers, and labs must meet QP expectations. If they’re not audit-ready, they’re a liability.

• Assesses risk across the supply chain: The QP’s proactive reviews can flag misalignments early, preventing rescue shipments or regulatory delays.

Why It Matters (A Lot More Than You Think)

Late QP engagement is one of the top reasons for Phase I shipment delays. Sponsors often wait until product is ready to release, only to find out documentation is incomplete, labeling doesn’t match, or vendor qualifications weren’t up to spec.

Each of those missteps = weeks lost and six-figure damage in expedited logistics, rework, or protocol amendments.

Now flip that: when a QP is involved early, they set expectations, align vendors, and build a certification-ready workflow into your operations. That doesn’t just protect your trial—it accelerates it.

Best Practices Worth Adopting

• Engage QPs early. Ideally before tech transfer or packaging starts. They’ll guide documentation and reduce surprises during release.

• Build audit-readiness into SOPs. If your packaging vendor or depot can’t pass a QP audit, they shouldn’t be on the team.

• Make documentation frictionless. A well-organized document trail is the fastest path to batch certification.

Bottom Line

The QP isn’t just there to check a box. They safeguard trial timelines, budget integrity, and patient access. Early engagement and tight alignment with your QP can save months—and hundreds of thousands of dollars—in avoidable disruption.

If you’re building out a global trial strategy, the smartest move you can make is designing it with the QP in mind from day one.