Process definition
- Sequence
- Unit operations and material flows
- Controls
- Parameters, ranges and quality attributes
- Basis
- Studies, models and risk assessments
Keep the process connected as it changes.
Product lifecycle management (PLM) in Seal connects process definitions, site versions and supporting evidence. Carry development knowledge into executable protocols without losing what each site actually ran.
Explore this workflow
One process definition. A connected lifecycle.
Keep the recipe, the scientific rationale and each site’s execution connected—from process development to manufacturing, MSAT and CMC.
Versioned process definition
Keep the science behind each setting.
Configure the unit operations, materials, equipment requirements and parameter ranges together. Run development protocols against a named recipe version; connect each proposed control to its experiments, quality attributes and reviewed rationale.
Carry the definition and its evidence into the next study or site assessment, including what is not yet established.
Run the intended version at the intended site.
Configure the local protocol from the process definition: instructions, fields, calculations, material references and review steps. Retain actual lots, cell-bank lineage where relevant, equipment and results with the version used for the batch.
Transfer the selected structure to a receiving site, then assess local equipment, scale and material differences before use.
Site execution record
- Instructions
- Site version and approved workflow
- Actual use
- Materials, equipment and genealogy
- Execution
- Readings, exceptions and review
Follow a finding back to the process it concerns.
Compare campaign performance by process version and site. Keep deviations, continued process verification (CPV), material changes and comparability evidence linked to the affected operation. Assess the next revision without rewriting earlier executions.
Route the proposed change and required evidence to the responsible site and quality reviewers. Implementation remains an explicit decision.
Process change assessment
- Difference
- Changed setting, material or operation
- Impact
- Sites, studies and active work
- Evidence
- Trends, comparability and verification
Describe the process that the evidence actually supports.
Connect process descriptions, material controls, parameter justifications and validation summaries to their underlying versions. Keep the submitted baseline distinct from a working revision so regulatory authors can review what changed and which statements need attention.
Regulatory reviewers assess filing impact and applicable commitments. A new process proposal is not automatically an updated submission.
CMC source package
- Baseline
- Selected process and site versions
- Support
- Development and manufacturing evidence
- Change review
- Affected statements and commitments
Same product. Which process is each site using?
A proposed capture-step revision is ready for assessment. The development study, existing manufacturing record and receiving-site package are at different points in the lifecycle.
Capture operation / process family P-014
Development study
P014-PD- Process family
- P-014
- Proposed version
- v05
- Owner
- Process development
Development has proposed process v05 after a capture study. The proposal and supporting assessment are available; this is not an instruction to change routine manufacturing.
What follows
Review the development evidence, change rationale and applicability to the intended sites.
Prepare the impact review for process v05.
neil
Development has proposed v05. North’s completed batch keeps v04, and South’s v05 package is still under review. I would assess the two sites separately rather than treating the proposal as globally effective.
P-014 / v05 impact review
DraftThe proposal, historical execution and receiving-site readiness are three different records. Resolve each before implementation.
PD lead
Attach the capture study and reviewed rationale for proposed v05.
North site owner
Retain B-114’s v04 execution and scope any future change.
South MSAT lead
Complete the receiving-site applicability assessment and execution readiness review.
Keep the detail that matters.
A recipe carries its scientific basis.
Keep the study, risk assessment and quality response behind each proposed control.
Connect a parameter to the quality attributes it may affect without treating every parameter as critical. Preserve the rationale, uncertainty and applicable scale or material coverage alongside the setting.
Transfer the structure, then resolve the differences.
Reuse the process definition and record what must change at the receiving site.
Equipment, scale, materials, methods and local procedures can change the meaning of an instruction. Keep those differences explicit and route the agreed qualification, verification and training work before implementation.
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 integrationsBefore you get started.
No. The process definition can inform executable protocols, with fields, calculations, material references and review steps. Documents and external records remain part of the supporting evidence.
No. Define which system owns process control, source measurements, inventory and orders. Scope connections around the records and actions the workflow needs.
No. Reusing the definition reduces reconstruction, but the receiving site must assess differences and complete the required evidence, training and authorisation.