Summary
- The problem
- PPQ evidence sits across manufacturing, laboratory and quality records, and the package is often assembled at the end. A finished campaign can look complete while a protocol exception still has no assessment.
- Seal’s approach
- The validation basis, PPQ protocol, execution records, reviewed results and exceptions are connected records. Each requirement is reviewed against the full evidence set, including missed steps and unsuccessful outcomes.
- What changes
- Review starts from open exceptions and evidence coverage rather than a batch count. Each conclusion traces to its evidence, and reviewed controls and residual risks carry into continued process verification.
- Where to start
- A PPQ protocol and one requirement whose supporting evidence is difficult to assemble. Book a demo.
From the validation basis to continued verification.
Coordinate process performance qualification (PPQ) as executable work: the protocol, readiness, campaign evidence and scientific conclusion stay connected.
New process knowledge informs the next assessment.
Start with the claim you need to support.
Record the product, process version, site and scale. Configure the PPQ protocol with its scientific sampling rationale, required process and quality evidence, acceptance criteria and planned analysis. Keep the development and characterisation basis attached.
Review prerequisite evidence and the protocol before execution. The selected campaign design needs its own justification.
PPQ protocol
- Scope
- Process, site, scale and campaign
- Requirements
- Sampling, criteria and analysis plan
- Readiness
- Facilities, equipment, methods and personnel
Capture the evidence where the work happens.
Run the protocol in Seal with attributable readings, material use, sample collections and exceptions. Connect historian and laboratory records to the relevant batch, phase and requirement. Reconcile missed, cancelled or replaced work against the original plan.
Retain the complete campaign population and original evidence, including unsuccessful outcomes, for scientific review.
Campaign execution
- Manufacturing
- Actual parameters and interventions
- Laboratory
- Samples, methods and reviewed results
- Exceptions
- Departures, missing evidence and impact
Make the conclusion traceable—not just the report.
Review requirement coverage, protocol exceptions and statistical conclusions together. Keep the dataset, exclusions, analysis version and assumptions with each calculation. Distinguish a passing result from sufficient evidence for the overall process claim.
Prepare the report from the reviewed record set. Authorised reviewers decide the conclusion and any remaining commitments.
Validation review package
- Traceability
- Requirement → evidence → conclusion
- Statistics
- Dataset, method, assumptions and outputs
- Decision
- Exceptions, limitations and approval
Carry the knowledge into routine manufacture.
Connect continued process verification to the process version, quality measures and residual risks established during validation. Define the monitoring population, review rules, responsibilities and response to signals or process changes.
New evidence can prompt reassessment or further qualification work. Preserve the original validation conclusion and its basis.
Continued verification plan
- Monitor
- Process and quality measures
- Interpret
- Version-aware populations and signals
- Respond
- Review, investigation and change assessment
The campaign finished. The evidence is not yet complete.
This example PPQ package has recorded execution, reviewed laboratory results and an open protocol exception. A completed batch count does not settle the validation conclusion.
PPQ-014 / evidence review
Protocol exception
PPQ014-EX- Exception
- EX-014
- Issue
- Planned sampling time missed
- Impact assessment
- Open
EX-014 concerns a missed planned sampling time. The exception remains open. The package contains no approved assessment of its effect on the evidence or campaign conclusion.
What follows
Assess the missing evidence and any justified additional work before finalising the conclusion.
Execution and reviewed laboratory results are present, but EX-014 has no completed impact assessment. I would put that sampling exception and the evidence-population check at the front of the review.
PPQ-014 / review agenda
DraftThe package is ready for a focused evidence review, not a claimed validation approval. Resolve the sampling exception and verify coverage.
Validation lead
Assess EX-014 and determine whether additional evidence is needed.
Manufacturing reviewer
Confirm the campaign records and executed process versions.
QC reviewer
Reconcile required samples and reviewed results.
What the validation record keeps.
Why teams choose Seal for process validation
A process validation report is usually assembled from manufacturing, laboratory and quality systems after the last batch of the campaign. Seal connects the validation basis, protocol, execution records, results and exceptions, so each requirement is reviewed against its evidence as it arrives.
Reviewed controls and residual risks carry directly into continued process verification, and a later process change starts from the evidence that supported the original conclusion.
Sampling has a reason.
Retain the scientific basis for the selected batches, locations, times and measurements.
The design should address variability and the intended claim. Do not replace a justified campaign design with a universal batch-count rule. Preserve changes to sampling and their effect on the interpretation.
Exceptions stay in the evidence.
A missed sample, a replaced run or an unsuccessful result remains part of the campaign record.
Record each departure against the requirement it affects, with its impact assessment and any justified additional work. Replacement work keeps its link to the original plan. Assessing an exception and approving the campaign conclusion are separate decisions.
A conclusion keeps its analysis.
A statistical conclusion needs the dataset and method behind it.
Keep the selected population, exclusions, assumptions, analysis version and outputs with each calculation, including analyses run in your existing statistical tools. A passing result is not the same as sufficient evidence for the overall process claim; authorised reviewers decide that.
Continue with the same process knowledge.
Carry reviewed controls, residual risks and monitoring commitments into continued process verification.
Define what will be monitored, which population and methods apply, and how signals trigger review. Future changes or new evidence can prompt reassessment without replacing the original PPQ record.
Connected to the surrounding work.
Keep specialised systems where they belong. Agree the source of each record, the permitted actions and the reconciliation at each handoff.
Explore integrationsAQuestions and answers
Does a fixed number of batches establish validation?
No. The campaign and sampling design need a scientific justification for the process and intended claim. Batch count alone does not establish process performance.
Can we retain our statistical tools?
Yes. Keep the selected dataset, analysis version, exclusions, assumptions and diagnostics linked to the protocol and reviewed conclusion.
Is an open exception always a failed campaign?
Not automatically. The authorised team assesses its significance and the adequacy of the evidence. Preserve the exception and decision; do not silently mark it resolved.