Combination products. One release across two quality systems.

A combination product can contain a drug, biologic, and device in one physical product, one package, or one intended therapeutic system. Manufacturing must preserve the genealogy and controls of each constituent while proving that the finished combination performs as intended.

Seal joins product configuration, drug or biologic lots, device components, assembly, filling or packaging, essential performance, inspections, quality events, design changes, and release. The finished record can be traced into both the pharmaceutical batch history and the device design and production history without duplicating the product between quality systems.

A prefilled syringe, autoinjector, inhaler, drug-eluting device, wearable delivery system, or co-packaged kit may cross organizational and system boundaries. Drug operations track formulation and batch. Device operations track parts, revisions, suppliers, assembly, and acceptance. Packaging may create the first record where the constituents appear together.

Seal makes the combination product the common parent. Each finished unit or lot retains the drug or biologic source, device bill of material and revision, assembly and packaging execution, inspections, test results, labels, and disposition.

The relationship is not a document attachment. A change, deviation, complaint, or recall can traverse from either constituent to the complete affected population.

The approved configuration defines constituent parts, drug or biologic presentation, device components and revisions, software or firmware where applicable, packaging, labels, specifications, assembly steps, test methods, and release requirements.

Seal maintains those elements as governed records with effectivity and approval. The executable manufacturing record resolves the exact configuration for the product, market, site, and date. Superseded or incompatible parts cannot be selected simply because inventory exists.

The FDA definition of combination-product types includes products physically combined, co-packaged, or intended for use together under defined circumstances. The operating model must therefore represent relationships beyond a conventional material bill.

Drug substance, formulated bulk, filled container, cartridge, syringe barrel, stopper, needle, device body, spring, adhesive, electronics, packaging, and other components can each have lot, serial, revision, supplier, status, storage, and acceptance history.

Seal verifies each constituent at issue and assembly. Lot-controlled parts remain traceable to the finished lot. Serialized parts remain traceable to the finished unit. Pooled, split, reworked, replaced, or scrapped populations retain their transformations and reason.

Backward tracing from a complaint identifies the exact drug lot, device part lots or serials, configuration, assembly line, tools, operators, tests, and packaging. Forward tracing from a supplier notice identifies every in-process, released, distributed, returned, or destroyed unit affected.

Some products join constituents during filling; others during final assembly or co-packaging. The electronic traveler must represent pharmaceutical controls, discrete assembly, and the handoff between them.

Seal can execute material dispensing, filling, stoppering, inspection, assembly, torque or force steps, software loading, labeling, packaging, and reconciliation in one controlled route. Each step checks eligible material, part revision, equipment, tool, fixture, user qualification, prerequisite, and acceptance state.

Measurements can enter from balances, filling equipment, vision systems, force or torque testers, electrical testers, or controlled manual observation. The record preserves source data and the decision made from it.

Device and combination-product requirements, risks, design outputs, verification, validation, usability, and transfer evidence establish why the manufactured configuration is acceptable.

Seal's Medical Device blueprint manages that design-control traceability. Commercial manufacturing references the released outputs rather than recreating them in a batch record. A critical dimension, assembly tolerance, essential performance test, or label requirement can trace back to the approved requirement and risk control that established it.

Production data closes the loop. Nonconformance, complaint, test yield, and process trend can identify a design or risk signal. The affected requirement, drawing, specification, test, process, and released population remain connected through change control.

Device components and drug-product materials may follow different supplier, sampling, certificate, inspection, test, and change-notification controls. The finished product depends on both.

Seal maintains approved supplier and manufacturer relationships, part or material revisions, incoming lots, certificates, inspection or test results, deviations, and disposition. A component cannot be issued when its supplier, revision, lot status, expiry, storage, or change state is unacceptable.

Supplier changes can identify every design output, process, validation, inventory population, active work order, and regulatory obligation requiring assessment. Existing stock does not automatically inherit approval for the new state.

Molds, nests, crimp tooling, assembly fixtures, gauges, test fixtures, software loaders, torque tools, vision recipes, and other production aids can determine finished performance. Their identity and version belong in the execution record.

Seal checks qualification, calibration, maintenance, setup, program or recipe, cleaning where applicable, and current allocation before use. Pre-use or challenge checks become executable steps. An out-of-tolerance finding traces forward to every lot or serial tested or assembled during the assessment interval.

Tool changes and repairs remain linked to the validation and first product population produced afterward.

The finished combination may need to demonstrate delivered volume, dose accuracy, injection time, activation force, break-loose force, leakage, occlusion response, connectivity, software behavior, or other product-specific performance.

Seal creates inspection and test work from the effective specification and sampling plan. Units, serials, samples, fixtures, methods, programs, raw data, calculations, acceptance, failures, and review remain connected to the finished population.

A failure cannot be reduced to a final pass rate. The system retains the failed unit, failure mode, original result, investigation, retest or replacement rationale, disposition, and impact on the sampled population.

Pharmaceutical organizations may call an unexpected execution event a deviation; device organizations may call a component or unit failing requirements a nonconformance. Combination-product operations need both meanings without creating parallel investigations for the same event.

Seal begins with the affected object and process context. The event can classify pharmaceutical process deviation, nonconforming product, laboratory OOS, design issue, supplier issue, or multiple concerns while sharing containment, investigation, risk, disposition, CAPA, and change links.

Affected drug lots, device parts, serials, work orders, tests, shipments, and complaints remain one population. Required reporting or field-action assessment can proceed from the same evidence.

The final release record resolves requirements from the drug or biologic constituent, device constituent, assembly and packaging process, essential performance, labels, quality events, and applicable market configuration.

FDA's CGMP guidance for combination products explains the application of applicable CGMP requirements to combination products under 21 CFR part 4. Seal does not replace regulatory determination; it makes the configured control strategy executable and reviewable.

QA sees which required evidence is complete, which exceptions affect disposition, and which configuration the lot or unit actually represents. Release changes finished-product eligibility without erasing constituent statuses or histories.

A complaint may describe dose delivery, leakage, device activation, particulate, packaging, labeling, drug quality, usability, software, or an adverse event. Triage needs the complete product configuration and history.

Seal links the complaint to lot or serial, drug and device constituents, design revision, manufacturing and test history, distribution, prior events, and retained samples. Investigation can compare similar units by component lot, line, tool, process version, or drug batch.

Field action and recall scope can traverse either direction. A drug-lot issue finds every combined unit containing it. A device-part issue finds every unit assembled with the affected revision or lot. Returned-product analysis feeds results back into complaint, risk, CAPA, and change records.

A change to drug formulation, container closure, device part, material, tolerance, software, supplier, assembly process, test method, package, label, or site can affect the other constituent and the finished combination.

Seal maps dependencies before approval: products, requirements, risks, design outputs, process definitions, validations, specifications, methods, suppliers, inventory, active work, stability, labels, submissions, and training. The change plan identifies which evidence must be generated and which populations may use the new state.

Effectivity remains explicit. Historical lots and serials retain their actual configuration, while new production can only select the approved combination of constituent versions.

A combination-product implementation should trace one representative lot or serial from approved configuration and constituent receipt through assembly, testing, packaging, release, distribution, complaint, returned-product analysis, and change impact.

Exercise a wrong part revision, failed essential-performance test, out-of-tolerance fixture, drug-lot deviation, component supplier change, rework, label correction, and complaint. The system is ready when pharmaceutical, device, quality, engineering, laboratory, and regulatory teams see one product history rather than reconcile two systems.