Industries · Pharmaceutical & life sciences · UK
Supplier qualification records,
organised and in date.
Under GMP, supplier qualification is a documented, living record.
Under the framework overseen by the MHRA, the holder of a manufacturing or wholesale authorisation carries direct responsibility for the quality of everything entering its supply chain. EU/UK GMP Chapter 5 is explicit that the selection, qualification, approval and maintenance of suppliers should be documented as part of the pharmaceutical quality system. Qualification is not a one-off procurement decision; it is a documented, evidence-backed, continuously maintained record.
The stakes are patient safety and licence retention, so the paperwork is unforgiving. Every approved supplier needs current evidence on file: valid licences, GMP or GDP certificates, quality agreements, audit reports, CAPA follow-through and re-qualification at risk-based intervals. When an inspection arrives, the difference between a clean outcome and a finding is often simply whether you can produce complete, in-date, traceable documentation on demand.
A tracking layer for qualification and CAPA.
Important: Supplio is not a validated eQMS and does not provide GxP or 21 CFR Part 11 validation, run audits, or replace your quality system. It helps you organise and track the supplier documentation, qualification records and CAPA correspondence a GMP/GDP quality system depends on.
Branded supplier portal
A self-service portal your suppliers log into, carrying your logo, accent colour and welcome message.
Supplier onboarding
Invite a supplier, send them onboarding forms, and review submissions in a queue where you approve or request changes.
Document store with expiry tracking
Store the documents suppliers upload, with expiry dates and automatic reminders as they approach.
Certification tracking
Record each supplier certification with its issuing body, issue and expiry dates, and live status.
Risk register with a 5x5 heatmap
Log supplier risks by likelihood and impact and see them on a clickable 5x5 heatmap.
CAPA with a supplier response loop
Raise a corrective action, assign it, let the supplier respond through the portal, then accept it or send it back.
Contract repository
Store supplier contracts with start, end, notice period and renewal, and get alerted before they expire.
Immutable audit log
Every change is recorded in an immutable, filterable audit log you can export to CSV.
Qualification, agreements and CAPA.
GMP, GDP and MHRA oversight
UK pharmaceutical activity operates under Good Manufacturing Practice for manufacturers and Good Distribution Practice for wholesalers, both enforced by the MHRA through inspection and licensing. GMP Chapter 5 requires you to qualify and maintain suppliers of starting materials and to audit active-substance manufacturers.
- Document supplier selection, qualification, approval and maintenance (GMP 5.27)
- Source only from holders of a valid authorisation, verified against the register
- Ongoing due diligence, including monitoring for non-compliance statements
- Re-qualification set by quality risk management, not a fixed calendar alone
Sources: MHRA GMP/GDP (GOV.UK). Checked 2 July 2026.
Approved supplier lists and quality agreements
Qualification produces two governing artefacts: the approved supplier list, and, for outsourced GMP/GDP activities, a written quality or technical agreement. A supplier should only reach the approved list once assessment, approval and any required agreement are complete.
- Approved status backed by licences, certificates, questionnaires and audits
- Deficiencies identified with corrective actions tracked to closure (GMP 5.29)
- Quality agreements defining responsibilities under GMP Chapter 7
- Re-audit intervals set by quality risk management
Sources: ECA: GMP supplier qualification. Checked 2 July 2026.
Self-inspection, CAPA and document control
A qualified supply base only stays qualified if the quality system keeps checking itself. ICH Q10 treats CAPA as a core pillar of the pharmaceutical quality system, and its logic extends to suppliers: a supplier deviation or failed audit should trigger a documented corrective and preventive action with evidence of effectiveness.
- CAPA structured from problem statement through effectiveness check (ICH Q9/Q10)
- Supplier deviations, complaints and audit findings are recognised triggers
- Document control demands attributable, legible, retrievable records (GMP 4)
- Certificates, licences and agreements kept current, with expiries acted on
Sources: FDA / ICH Q10 CAPA. Checked 2 July 2026.
Pharma supplier qualification, answered.
What is supplier qualification in GMP?+
Can software make us GMP or 21 CFR Part 11 compliant?+
How do I manage CAPA with suppliers?+
What is an approved supplier list and when does a supplier go on it?+
Do I need a quality agreement with every supplier?+
See it against your own suppliers. Prices are on the website, in GBP.
Q1 evidence pack
Suppliers · Compliance · Scope 3
Two weeks from now you could be exporting a board-ready evidence pack instead of patching a v17 spreadsheet. Transparent UK pricing, Stripe-secured, cancel any time.
- UK-built · GDPR & UK DPA 2018
- Transparent GBP pricing · no hidden seats
- Founder-led UK support