Manufacturing & Supply Chain
Compliant Procurement Excellence.
We optimize procurement processes for life sciences companies—from supplier selection and qualification to quality agreements and GMP-compliant tender and contract management.
What compliance risks arise in regulated procurement?
In the life sciences sector, procurement is not merely an operational function—it is critical from a regulatory standpoint:
- Changing suppliers without a comprehensive change control process can result in GMP findings
- The absence of or inadequacy in quality agreements with critical suppliers is a common audit finding
- Procurement decisions are made purely on the basis of cost—without assessing supply chain compliance risks
- Shortcomings in the supplier audit program: critical suppliers are not audited, or are audited too infrequently
Do you have current quality agreements and conduct regular supplier audits for all of your critical suppliers?
Our services.
We incorporate regulatory requirements into efficient procurement processes.
Procurement Process Design & SOP Development
Design of comprehensive, GMP-compliant procurement processes: requirements definition, request for proposals, supplier selection, risk assessment, and change control when switching suppliers. SOPs for all process steps.
Quality Agreements & Contract Management
Drafting and reviewing quality agreements (QA) with critical suppliers: responsibilities, GMP requirements, communication obligations, change notification, and audit rights. → [Supplier Development](/expertise/supplier-development-qualification)
Supplier Risk Assessment & Categorization
Risk-based categorization of the supplier portfolio: critical, important, and standard suppliers. Risk-based approach to audit frequency and monitoring intensity in accordance with GMP requirements.
Procurement KPI System & Process Metrics
Development of an operational procurement performance system: on-time delivery, quality metrics, supplier evaluations, and regulatory compliance scores. A foundation for data-driven procurement decisions.
Frequently Asked Questions About Compliant Procurement.
What is a Quality Agreement (QA) with suppliers?
A Quality Agreement is a contractually agreed-upon document between the client and the supplier that defines their respective quality and GMP responsibilities. It governs: GMP standards, change notification requirements, audit rights, complaint procedures, traceability, and nonconformity management.
Which suppliers need a quality agreement?
All suppliers that provide GMP-relevant materials or services: active pharmaceutical ingredients (APIs), excipients, primary packaging, sterilization service providers, CDMOs, testing laboratories, and suppliers of critical components. IT service providers for GMP systems may also be subject to QA.
How often should supplier audits be conducted for critical suppliers?
There is no fixed frequency specified by regulation—the requirement is risk-based. Typically: critical suppliers (API, CDMOs) every 1–2 years; key suppliers every 2–3 years; standard suppliers less frequently or only on a questionnaire basis. The FDA and EMA expect a documented, risk-based audit program.
What is the difference between supplier qualification and supplier development?
Supplier qualification is the initial assessment and approval of a new supplier for GMP-compliant use. Supplier development is the ongoing support and development of the supplier to improve its performance and compliance capabilities. → [Supplier Development](/expertise/supplier-development-qualification)
Related topics.
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