SALES – Sales Business Process
The Sales (SALES) business process governs the controlled intake, validation, documentation, and management of customer requirements, commitments, and communications to ensure all commercial agreements align with approved GMP capabilities, specifications, and Quality System controls.
Sales Operating Model
The Sales Operating Model below illustrates how customer requests and commitments are evaluated, validated, approved, and documented prior to execution within GMP manufacturing and quality operations.
Customer inquiries and requests
Commercial and technical requirements
Proposed specifications and claims
Controlled customer communications aligned to approved internal information
Collection, validation, and approval of customer product specifications
Risk assessment, capability validation, and pricing development
Creation and maintenance of PMAs, SOWs, and governing agreements
Approved customer specifications
Executable commercial agreements
Controlled commitments supporting GMP execution
Sales activities establish binding commitments that directly impact GMP manufacturing, testing, labeling, and packaging. No customer commitment may exceed approved internal capabilities or bypass Quality System controls.
Process Interfaces & Boundaries
- Upstream: Market engagement and customer inquiries
- Downstream: Procurement, Material Readiness, Production, Packaging, and Quality – execution of approved commitments
- Governance: QMS defines commitment review, approval, and escalation rules; Sales executes controlled customer engagement
Controls Embedded in Sales Execution
Sales execution incorporates controls to ensure customer-facing commitments are accurate, traceable, and fully aligned with approved GMP capabilities and Quality Control requirements.
- Controlled customer communications regarding quality, specifications, and capabilities
- Validation and approval of customer product specifications
- Cross-functional feasibility and RFQ risk assessment
- Formal control of PMAs, SOWs, and commercial agreements
- Defined rules of engagement, authority limits, and escalation pathways
Misaligned commitments, specification gaps, or unauthorized customer communications identified during Sales activities are documented and escalated through Quality Event, change control, or contract review processes in accordance with the enterprise Quality System.