Supplier qualification establishes that a supplier of starting materials, packaging, services or contract work can consistently meet GMP and the buyer’s requirements. It typically combines a risk assessment, questionnaires, document review, on-site or remote audits, test results for initial lots, and a written quality agreement that sets out each party’s responsibilities.
Qualification is not a one-off. Approved suppliers are re-assessed at a frequency based on risk and performance — complaints, rejected lots, audit findings — and the approved supplier list is kept up to date, with suspended or expired sources blocked from use.
Why it matters in GMP
EU GMP Chapter 5 requires starting materials to be purchased only from approved suppliers, and Chapter 7 requires a written contract or quality agreement for outsourced activities. ICH Q10 extends the quality system to outsourced activities and purchased materials, and Revised Schedule M in India makes supplier qualification explicit. Contaminated or falsified materials from unqualified sources have caused serious patient harm.
- Qualify both the supplier and the actual manufacturing site.
- Keep a quality agreement in force for each approved supplier.
- Check approval status every time a purchase order is raised.
How Swat iQua Suite handles it
Swat iQua Suite runs supplier assessments per site, with scheduled assessments created automatically from assessment plans, signatures that cannot be changed and are tied to an assessment version, and performer, reviewer, approver and co-signer kept separate. Qualification scopes and site risk ratings drive audit frequency, and versioned quality agreements are prepared, reviewed and approved. A purchase order line can only use an approved supplier list source that passes the gate on the PO date — including a quality agreement in force.