Process validation

The process itself is proven on the new asset: Stage 1 design carried into Stage 2 process performance qualification, with computerised systems validated under GAMP 5 and cleaning and environmental baselines established.

Purpose

Demonstrate the manufacturing process is reproducible and in a state of control on the qualified asset.

Work performed

• Carry Stage 1 process design knowledge into a Stage 2 process validation plan
• Execute process performance qualification (PPQ) batches against pre-defined criteria
• Validate computerised systems (GAMP 5) and establish cleaning and environmental-monitoring baselines
• Compile the PPQ report and confirm the process is in a state of control

Who is involved

• Process/validation engineers and manufacturing science (MSAT)
• Quality Assurance approving the plan, batches, and PPQ report
• QC laboratory, CSV, and cleaning-validation SMEs

What quality owns

• Approval of the process validation plan, PPQ protocol, and acceptance criteria
• The disposition of PPQ batches and the state-of-control conclusion

What engineering owns

• Equipment and utility performance supporting the validated process
• Support to resolve process/equipment issues arising in PPQ

What operations owns

• Execution of the PPQ batches under routine, representative conditions
• The trained operators and procedures the validated process depends on

Management decisions

• Commitment of API/material and schedule to the PPQ campaign
• Acceptance of PPQ outcomes and authorisation toward commercial supply

Deliverables

• Process validation plan and PPQ protocol
• Executed PPQ batch records and the PPQ summary report
• CSV, cleaning-validation, and monitoring baseline records

Evidence to retain

• The approved PPQ protocol and summary report
• Cleaning-validation and monitoring baselines that anchor Stage 3

Common risks

• PPQ run before Stage 1 knowledge is adequate, risking a failed campaign
• Cleaning or monitoring baselines set too thin to support routine limits
• CSV not complete, so data supporting PPQ is not trustworthy

Gate criteria to advance

• A process validation plan carrying Stage 1 knowledge into Stage 2
• PPQ batches executed and meeting pre-defined criteria
• CSV, cleaning validation, and monitoring baselines established

Expensive if deferred

• Stage 1 process understanding — thin design knowledge shows up as a failed, costly PPQ campaign
• Cleaning and monitoring baselines — retrofitting them delays commercial release

Business effect

PPQ is the gate to commercial supply; a process not shown to be in control cannot lawfully ship, and a failed PPQ campaign is a direct schedule and cost hit.

Greenfield vs brownfield

A technology transfer or brownfield line may run a confirmatory PPQ leveraging the sending site’s knowledge; a greenfield process is validated from first principles on a brand-new asset.