Checklist: Combination Product Disposition, Device Constituent Addendum

This is a ready-to-use addendum checklist. It does not replace the general batch disposition package review; it adds the device-constituent items a drug-only checklist does not ask for. Complete it alongside checklist: batch release disposition package review for any drug-led or biologic-led combination product. Mark each item Pass, Fail, or NA, record the evidence reference, and route any Fail per your deviation procedure before the disposition authority signs. Replace every <<FILL: ...>> placeholder. A filled specimen follows.

How to use this addendum

Complete one addendum per batch, tied to the same disposition record as the general package checklist.
A Fail on any item here blocks release exactly as a Fail on the drug side does; the device constituent is not a lesser check.
The reviewer confirming device items should be able to read a functional test result, not only a drug cGMP record; name the qualified reviewer in the header.
If the product is device-led rather than drug-led, confirm with Regulatory Affairs which base quality system and disposition framework actually applies before using this addendum.

Field	Entry
Product / combination product configuration	`<<FILL: e.g. prefilled autoinjector, drug-led>>`
Batch / lot number	`<<FILL>>`
Device-constituent reviewer	`<<FILL: name, qualification>>`
Review date	`<<FILL>>`
Linked disposition record	`<<FILL: disposition record ID>>`

Section D: Device constituent

#	Item	Evidence reference	Basis
D1	Device functional/performance testing complete for this batch (dose accuracy, actuation force, injection time, as applicable) and within qualified range	`<<FILL>>`	21 CFR Part 4
D2	Device component lots used in this batch identified, with supplier qualification and incoming-inspection records current	`<<FILL>>`	21 CFR Part 4 / supplier qualification SOP
D3	No open device-attributable complaint, deviation, or CAPA implicates a component lot or process step used in this batch	`<<FILL>>`	Complaint handling / CAPA system
D4	Assembled combination product configuration matches the design output referenced in the marketing application	`<<FILL>>`	Design history file / design output record
D5	Container-closure and delivery-system integrity confirmed for this batch where applicable (e.g. seal integrity, needle-shield function)	`<<FILL>>`	Container closure integrity program
D6	Any device-side out-of-specification or atypical result closed with a documented impact assessment before this checklist is signed	`<<FILL>>`	21 CFR 211.192 (by cross-reference)

Disposition conclusion for this addendum

Field	Entry
All Section D items Pass or NA with documented reason	`<<FILL: Yes/No>>`
Any Fail resolved with a signed batch-impact assessment before release	`<<FILL: Yes/No/N/A>>`
Device-constituent reviewer sign-off	`<<FILL: name, signature, date>>`

Filled specimen

Header. Product: prefilled autoinjector, biologic-led combination product. Batch: AIX-2026-0091. Device-constituent reviewer: M. Oyelaran, device quality engineer. Review date: 2026-09-30. Linked disposition record: DISP-2026-1144.

#	Item	Pass / Fail / NA	Evidence reference
D1	Device functional testing	Pass	Functional test report FT-2026-0091, actuation force and dose accuracy within range for 32 of 32 sampled units
D2	Component traceability	Pass	Spring lot SPR-2026-118, supplier CoA and incoming inspection IR-4471 on file
D3	No open device-attributable event	Pass	CAPA log reviewed, no open item references this batch, lot, or line
D4	Matches design output	Pass	Configuration confirmed against design output record DHF-AIX-003, rev. 4
D5	Container-closure / delivery-system integrity	Pass	Needle-shield function test NSF-2026-0091, 100% pass
D6	No unresolved device OOS/atypical	NA	No atypical result recorded for this batch

Conclusion: all Section D items Pass or NA. Device-constituent reviewer sign-off: M. Oyelaran, signed, 2026-09-30. Disposition proceeds using both this addendum and the general disposition package checklist.

Common findings this addendum prevents

A batch released on drug-side results alone, with no device functional test result ever entering the disposition package.
Device component lot traceability maintained separately from the batch record and never actually checked at disposition.
A device-attributable complaint trend recognized by Quality but never cross-checked against the batch being dispositioned.
The assembled product’s configuration drifting from the design output referenced in the marketing application, with no one dispositioning against the current design output record.

How to adapt this addendum

Tailor Section D’s functional-test item (D1) to the actual device type: an inhaler checks dose uniformity and actuation count differently than an autoinjector checks actuation force and injection time.
If the combination product is co-packaged rather than single-entity, add an item confirming the packaging-step reconciliation between the two constituent manufacturing histories.
Route this addendum to the same disposition record ID as the general package checklist so an inspector sees one linked file, not two disconnected reviews.