Manufacturing & Supply Chain
Supplier Development & Qualification.
We help pharmaceutical, biotech, and medtech companies establish structured supplier qualification programs—from initial evaluation and audits to ongoing performance monitoring.
Why is supplier qualification critical in the life sciences sector?
Suppliers are part of your quality system—and therefore part of your regulatory risk:
- ISO 13485 and GMP require formally qualified suppliers for critical materials
- Undetected quality issues with suppliers lead to production downtime, recalls, and findings
- Single-source dependencies arise because alternative suppliers are not qualified
- Supplier audits are conducted sporadically and without a structured program
Do you have an up-to-date qualification status and a scheduled audit program for all critical suppliers?
Our services.
We develop comprehensive supplier qualification systems and assist with individual qualification processes.
Supplier Evaluation & Qualification Process
Design and implementation of a comprehensive supplier evaluation and qualification process: risk assessment, qualification checklist, quality agreement, and approval and re-qualification cycle.
Supplier Audits & Development Visits
Conducting qualification and surveillance audits at critical suppliers. Audit reports detailing classified findings and CAPA recommendations. Development visits to suppliers with room for improvement.
Supplier Performance Management
Development of a supplier performance rating system: KPIs for delivery quality, on-time delivery, and regulatory compliance. Escalation processes for underperforming suppliers. Systematic trend analysis for early warning.
Alternative Source Qualification
Strategic qualification of alternative and backup suppliers to mitigate single-source risks. Parallel qualification and regulatory change management planning for supplier transitions.
Frequently Asked Questions.
Which suppliers must be certified to ISO 13485?
All external suppliers whose products or services may affect the quality and safety of the final product. This includes material suppliers, contract manufacturers (CMOs), sterilization service providers, CROs, and critical service providers such as calibration service providers.
What is a quality agreement with a supplier?
A Quality Agreement is a binding contract that defines GMP requirements and quality obligations between the manufacturer and the supplier, including product specifications, change notification requirements, audit rights, complaint management, and regulatory obligations.
How often should supplier audits be conducted?
Risk-based: Critical GMP suppliers at least every 1 to 3 years. Non-critical suppliers can be monitored through questionnaire-based assessments. Initial findings and changes in criticality may affect the frequency.
What happens if a supplier performs poorly in an audit?
Depending on the severity of the findings: for critical findings, a temporary suspension of shipments and an immediate CAPA plan. For major findings: a CAPA plan with a deadline, followed by a follow-up audit after implementation. For minor findings: a written request for CAPA, to be reviewed at the next audit.
Related topics.
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