Combination product QMS.

1One product should not become two disconnected records.

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.

A prefilled syringe, autoinjector, inhaler, drug-eluting device, wearable delivery system or co-packaged kit may cross organisational 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, as in Figure 1. 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 finished record traces into both the pharmaceutical batch history and the device design and production history without duplicating the product between quality systems, so a change, deviation, complaint or recall can traverse from either constituent to the complete affected population.

1.1Why teams choose Seal for combination products

Combination products are usually run across a pharmaceutical quality system and a device quality system, joined in packaging and reconciled by hand when a complaint or supplier notice arrives. Both constituents’ genealogy, the device revision, assembly, testing and events form one record under the finished product, and a design or process change is assessed across both before it is approved. A drug-lot or device-part question is answered from the product record, without translating between two systems.

2The approved configuration controls what may be built.

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 Superseded or incompatible parts cannot be selected simply because inventory exists.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.

Device components and drug-product materials may follow different supplier, sampling, inspection and change-notification controls, and the finished product depends on both. A component cannot be issued when its supplier, revision, lot status, expiry, storage or change state is unacceptable. A supplier change identifies the design outputs, processes, validations, inventory and active work orders that need assessment, and existing stock does not inherit approval for the new state.

3Constituent genealogy remains intact after assembly.

Drug substance, filled container, syringe barrel, stopper, needle, device body, spring, electronics and packaging can each have their own lot, serial, revision, supplier, status and acceptance history.

Configured checks verify each constituent at issue and assembly. Lot-controlled parts remain traceable to the finished lot. Serialised 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.

4Pharmaceutical execution and device assembly share one traveler.

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, labelling, 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.

Tools and fixtures are production equipment. Moulds, crimp tooling, assembly and test fixtures, gauges, software loaders, torque tools and vision recipes can determine finished performance, so their identity and version belong in the execution record. Seal checks qualification, calibration, maintenance, setup and program before use, and pre-use challenge checks become executable steps. An out-of-tolerance finding traces forward to every lot or serial tested or assembled during the assessment interval.

5Design controls remain connected to manufacturing reality.

Device and combination-product requirements, risks, design outputs, verification, validation, usability and transfer evidence establish why the manufactured configuration is acceptable.¹

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.

6Test essential performance and investigate events once.

Essential performance is a release requirement. The finished combination may need to demonstrate delivered volume, dose accuracy, injection time, activation force, break-loose force, leakage or software behaviour. Seal creates inspection and test work from the effective specification and sampling plan, with units, fixtures, methods, raw data, calculations and review 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 organisations may call an unexpected execution event a deviation; device organisations 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, shipments and complaints remain one population, and any required reporting or field-action assessment proceeds from the same evidence.

7Release, complaints and change cross both constituents.

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 4.² 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.

A complaint about dose delivery, leakage, activation, particulates, labelling or drug quality links to the lot or serial, both constituents, design revision, manufacturing and test history, distribution and retained samples, so 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 formulation, container closure, device part, tolerance, software, supplier, assembly process, test method, label or site can affect the other constituent and the finished combination. Seal maps dependencies before approval, across requirements, risks, design outputs, processes, validations, specifications, 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.

8Prove one unit from constituents through complaint.

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 implementation is ready when pharmaceutical, device, quality, engineering, laboratory and regulatory teams see one product history rather than reconcile two systems.