PROC – Procurement Business Process
The Procurement (PROC) business process governs the sourcing, purchasing, and supply coordination of materials, components, and services required to support GMP operations, while ensuring supplier qualification, authorization, and traceability requirements are met prior to receipt.
Procurement Operating Model
The Procurement Operating Model below illustrates how approved suppliers and authorized materials are sourced, ordered, and coordinated to support downstream receiving, Material Readiness, and batch manufacturing activities.
Approved supplier list (ASL)
Material and service requirements
Demand forecasts / production plans
Supplier approval, quality agreements, and scope authorization
Issuance of purchase orders for approved materials and services
Order confirmation, delivery scheduling, and change management
Maintenance of purchasing records and supplier traceability
Authorized purchase orders
Qualified suppliers and materials
Traceable procurement records supporting receipt
Procurement activities are completed prior to material receipt. Physical custody and GMP control of materials begins only upon receipt into Warehousing and subsequent Material Readiness activities.
Process Interfaces & Boundaries
- Upstream: Business planning & demand forecasting
- Downstream: Warehousing (WH) and Material Readiness (MR) – receipt and readiness execution
- Governance: QMS defines supplier qualification and purchasing controls; Procurement executes sourcing activities
Quality Control Requirements Applicable to Procurement
Procurement is classified as a QC-Enabling Domain. Procurement activities support execution of defined Quality Control Requirements under the authority of Quality Control Operations (QCO) and in accordance with the Quality Control Requirements Index (QC-REQ-IDX).
- QC-MAT-003 – Supplier Qualification Status Impact: Procurement ensures that purchasing activity reflects current supplier qualification status and prevents sourcing from unqualified or restricted suppliers.
- QC-CHG-002 – Impact & Risk Assessment: Procurement identifies and escalates changes affecting materials, suppliers, or supply conditions to enable required quality impact and risk assessments prior to implementation.
Procurement does not independently execute Quality Control acceptance or disposition decisions. All Quality Control determinations remain under the non-delegable authority of Quality Control Operations (QCO).
Supplier-related deviations, qualification gaps, or supply risks identified during Procurement activities are escalated through the Quality Event or Supplier Management processes in accordance with the enterprise Quality System.