In the life sciences industry, your products are only as reliable as the partners you depend on. Whether you’re sourcing raw materials, reagents, packaging components, or contract manufacturing and testing services, supplier qualification and ongoing monitoring are essential to maintaining quality, compliance, and patient safety.
Both FDA and ISO 13485 require manufacturers to establish and document procedures for selecting, qualifying, and re-evaluating suppliers that affect product quality. In other words, you must demonstrate that your vendors consistently meet your standards, not just once, but over time.
1. Understand the Regulatory Requirements
Key regulations and standards outline supplier control obligations:
– 21 CFR Part 820.50 (FDA QSR) – Requires purchasing controls to ensure that products and services conform to specified requirements.
– ISO 13485:2016 (Clause 7.4) – Mandates a documented process for supplier evaluation, selection, monitoring, and re-evaluation based on their ability to meet requirements.
– ICH Q10 / GMP Guidelines – Expect oversight proportional to supplier risk and criticality.
Regulators often ask for evidence of:
– Approved supplier lists (ASL)
– Qualification records
– Quality agreements
– Periodic re-evaluation results
– Corrective actions for supplier nonconformities
2. Start With Risk-Based Supplier Classification
Not all suppliers pose the same level of risk. Start by categorizing them based on the impact they have on product quality and patient safety.
Example categories:
– Critical Suppliers: Provide components or services directly affecting product quality (e.g., API, sterilization, contract labs).
– Major Suppliers: Indirectly affect product quality or regulatory compliance (e.g., packaging, calibration, utilities).
– Minor Suppliers: Have minimal impact (e.g., office supplies, non-GMP services).
A risk-based approach allows you to tailor qualification depth, monitoring frequency, and auditing effort to each supplier’s criticality.
3. Perform Supplier Qualification
Step 1 – Initial Screening
Collect and review preliminary documentation:
– Business licenses and certifications (ISO 9001, ISO 13485, GMP, GLP)
– Quality manual or summary of QMS
– Product specifications and test methods
– Organizational structure and key contacts
Step 2 – Supplier Questionnaire
Send a Supplier Qualification Questionnaire to assess their quality systems, process controls, and regulatory compliance.
Common sections include:
– Document and record control
– CAPA and deviation handling
– Training and personnel qualifications
– Change control
– Sub-supplier management
– Data integrity and cybersecurity (for software vendors)
Step 3 – On-Site or Remote Audit
Critical or high-risk suppliers should undergo a formal audit before approval. The audit verifies that procedures are implemented effectively and not just described on paper.
Step 4 – Quality Agreement
Formalize expectations with a Quality Agreement that clearly defines:
– Responsibilities for quality assurance and regulatory compliance
– Communication and escalation processes
– Change notification requirements
– Record retention and audit rights
Once approved, the supplier can be added to the Approved Supplier List (ASL) with documentation supporting the decision.
4. Ongoing Supplier Monitoring
Qualification is just the beginning. Continuous monitoring ensures suppliers maintain compliance and performance over time.
Key Monitoring Tools:
– Performance Metrics (KPIs): Track on-time delivery, defect rates, CAPA responsiveness, and audit findings.
– Periodic Re-Qualification: Reassess suppliers at defined intervals based on risk (e.g., every 1–3 years).
– Change Control Review: Require notification of significant changes (process, equipment, location, or ownership).
– Complaint and Deviation Trending: Identify recurring quality issues that could indicate deeper problems.
– Audits and Reviews: Conduct follow-up audits when risk or performance concerns arise.
Best Practice:
Document all evaluations, trend analyses, and decisions in a Supplier Monitoring Log or within your QMS (electronic or paper-based). Regulators expect traceability of every review and justification for supplier status.
5. Manage Supplier Nonconformance
When a supplier fails to meet requirements:
1. Document the issue (e.g., through a Nonconformance or Supplier Corrective Action Request, SCAR).
2. Investigate the root cause collaboratively.
3. Define and verify CAPAs.
4. Re-evaluate supplier risk level.
5. Suspend or remove from the ASL if compliance cannot be restored.
Transparency and consistent communication are critical, both internally and with the supplier, to prevent repeat issues.
6. Integrate Technology for Efficiency
Modern QMS and eQMS platforms streamline supplier management by:
– Automating reminders for re-qualification and audits
– Linking suppliers to deviations, CAPAs, and change controls
– Providing dashboards for supplier KPIs and risk ratings
Systems like MasterControl, TrackWise, or Qualio can centralize all supplier documentation, making FDA or ISO audits far easier to navigate.
How Avendium Can Help
At Avendium, we help life science companies establish and maintain supplier and vendor qualification programs that meet FDA, ISO 13485, and GMP expectations.
Our consultants can:
– Develop or update your Supplier Qualification SOPs and forms
– Perform supplier audits and risk assessments
– Build Approved Supplier Lists and tracking systems
– Draft or review Quality Agreements
– Implement supplier monitoring metrics and reports
Avendium ensures your vendor controls are compliant, efficient, and audit-ready.
Contact us today to learn how we can support your supplier quality management system.