PROD – Production Business Process
The Production (PROD) business process defines how approved manufacturing instructions and released materials are executed to produce finished product through controlled, traceable, and documented manufacturing operations.
Production Operating Model
The Production Operating Model below illustrates how production activities are performed from receipt of approved inputs through completion of executed batch records and transfer of statused output to downstream processes.
Master Manufacturing Record (MMR)
Pre-weighed and staged materials (Material Readiness)
Production schedule / work order
Line clearance, equipment setup, and readiness confirmation
Execution of blending, filling, or processing steps per MMR
Monitoring, checks, adjustments, and in-process controls
Contemporaneous documentation of executed steps and observations
Executed batch record
Manufactured product
Statused output for Packaging or Warehousing
Material weighing, kitting, and staging activities are performed upstream within the Material Readiness (MR) process family. Production begins only after receipt of approved instructions and released, staged materials.
Process Interfaces & Boundaries
- Upstream: Material Readiness (MR) – material weighing, kitting, and release
- Downstream: Packaging (PKG) or Warehousing (WH) – based on product disposition
- Governance: QMS defines quality system controls; Production executes GMP operations
Quality Control Requirements Executed During Production
Production (Manufacturing) is classified as a QC-Executing Domain. Production activities execute defined Quality Control Requirements in accordance with the Quality Control Requirements Index (QC-REQ-IDX) under the authority of Quality Control Operations (QCO).
- QC-ENV-002 – Production Environmental Conditions: Production maintains defined environmental controls necessary to preserve product integrity during manufacturing operations.
- QC-IPC-002 – In-Process Acceptance Criteria: Production executes and documents in-process controls in accordance with approved acceptance criteria.
- QC-IPC-004 – In-Process Deviation Response: Production identifies, documents, and escalates in-process deviations in accordance with defined response requirements.
Final product disposition and release decisions remain governed by the applicable QC-DISP requirements. Production executes in-process controls but does not independently determine final disposition outside defined authority.
Deviations or out-of-tolerance observations identified during Production activities are documented and managed through the Quality Event and CAPA processes in accordance with the Quality System.