BENCH – Bench & Pilot Execution Business Process
The Bench (BENCH) business process governs the controlled execution of bench-scale, pilot, and development activities conducted to generate process knowledge, support method development, and inform GMP manufacturing without producing commercial product.
Bench Operating Model
The Bench Operating Model below illustrates how experimental and pilot activities are planned, executed, documented, and evaluated while maintaining segregation from GMP manufacturing and commercial product streams.
Approved study or protocol objectives
Authorized materials and reagents
Bench-scale equipment and tools
Definition of objectives, scope, and execution controls
Controlled experimental or pilot-scale processing activities
Recording of parameters, outcomes, and deviations
Evaluation of outcomes to inform development or manufacturing decisions
Experimental data and observations
Development reports or summaries
Inputs to process development or change control
Materials, intermediates, or products generated through Bench activities are not released for commercial use and are maintained under controlled segregation from GMP manufacturing streams.
Process Interfaces & Boundaries
- Upstream: Development planning, process improvement initiatives, and investigation needs
- Downstream: Process Development, Change Control, and GMP Manufacturing (as knowledge inputs only)
- Governance: QMS defines documentation, segregation, and authorization controls; BENCH executes approved studies
Quality Control Requirements Supported by Bench Execution
Bench Execution is classified as a QC-Enabling Domain when supporting GMP-relevant activities. Bench activities generate data and technical inputs that support 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-ANL-001 – Analytical Method Suitability: Bench activities evaluate and document method suitability prior to GMP application.
- QC-ANL-002 – Instrument & System Suitability: Bench execution verifies analytical and experimental system readiness where applicable.
- QC-ANL-003 – Measurement Uncertainty Impact: Bench data generation considers measurement variability when informing GMP decisions.
- QC-IPC-001 – Critical Process Parameter Governance: Bench findings impacting critical parameters are documented and escalated.
- QC-IPC-003 – Process Monitoring & Trending: Bench-generated data contributing to process understanding is recorded and traceable.
Bench execution does not independently establish GMP acceptance criteria or make disposition decisions. All Quality Control determinations remain under defined QC authority.
Findings, deviations, or observations from Bench activities that may impact GMP processes are evaluated through change control, investigation, or quality event pathways in accordance with the enterprise Quality System.