Record: GLP Test and Control Article Characterization and Accountability

This is a ready-to-use record for demonstrating that a GLP study’s test and control articles were characterized, stored, distributed, and, where applicable, mixed with a carrier, in accordance with 21 CFR 58 Subpart F. It is the front-of-study evidence that answers an inspector’s most basic question: how do you know the animals received what the report says they received. Replace every <<FILL: ...>> placeholder with your own specifics and file it with the study archive. A filled specimen follows. Verify each cited regulation against the current source before you rely on it.

Document control header

Field	Entry
Study number	`<<FILL>>`
Test article name / code	`<<FILL>>`
Control/vehicle article name / code	`<<FILL>>`
Record number	`<<FILL: REC-ID>>`
Retention	Filed with the study archive per 21 CFR 58.190/58.195

1. Characterization (58.105)

Field	Test article	Control/vehicle article
Batch/lot number	`<<FILL>>`	`<<FILL>>`
Identity confirmed by	`<<FILL: method, e.g. HPLC/MS against reference standard>>`	`<<FILL>>`
Strength / purity / composition	`<<FILL>>`	`<<FILL>>`
Certificate of analysis reference	`<<FILL>>`	`<<FILL>>`
Stability protocol reference	`<<FILL>>`	`<<FILL>>`
Stability confirmed for the study’s storage/use period	Yes / No, with data reference	Yes / No, with data reference
Re-analysis schedule (if stability is time-limited)	`<<FILL>>`	`<<FILL>>`

2. Handling: storage, distribution, and identification (58.107)

Field	Entry
Storage conditions specified	`<<FILL: temperature, light, humidity as applicable>>`
Storage location and access control	`<<FILL>>`
Receipt record reference	`<<FILL>>`
Distribution log reference (batch to dosing event)	`<<FILL>>`
Identification method preserved through distribution	`<<FILL: labeling scheme confirmed at each transfer point>>`

Date	Action	Quantity	From / to	Person	Batch confirmed
`<<FILL>>`	Receipt	`<<FILL>>`	Vendor to Test Article Storage	`<<FILL>>`	Yes/No
`<<FILL>>`	Distribution to dosing area	`<<FILL>>`	Storage to `<<FILL: room/area>>`	`<<FILL>>`	Yes/No
`<<FILL>>`	Return of unused material	`<<FILL>>`	`<<FILL>>` to Storage	`<<FILL>>`	Yes/No

3. Mixtures with a carrier, if applicable (58.113)

Field	Entry
Carrier used	`<<FILL: feed / drinking water / dosing vehicle>>`
Nominal concentration	`<<FILL>>`
Uniformity testing method and result	`<<FILL>>`
Periodic concentration verification schedule and results	`<<FILL>>`
Stability of the mixture confirmed for the in-use period	Yes / No, with data reference
Not applicable (no carrier mixture used)	`<<FILL: check if N/A>>`

Acceptance criteria

Every batch used in the study has a characterization record and a stability determination covering its actual storage and use period.
Storage conditions match the specification and access is controlled and logged.
Distribution is traceable batch by batch from receipt to the dosing event, with identity preserved at every transfer.
Where a carrier mixture is used, uniformity, concentration, and stability of that specific mixture are analytically confirmed, not assumed from the nominal formulation.
No gap exists between the batch characterized and the batch actually administered.

References

21 CFR 58.105, Test and control article characterization. 21 CFR 58.107, Test and control article handling. 21 CFR 58.113, Mixtures of articles with carriers.

Confirm the current version of each reference before issue.

Filled specimen (excerpt)

Field	Entry
Study number	TX-2026-031
Test article batch	TAX-0472-B, purity 99.6% by HPLC against USP reference standard, CoA CoA-2026-0472
Stability	Confirmed stable for 90 days at 2-8°C protected from light per stability protocol STAB-TAX-04; study duration 42 days, within the confirmed window
Carrier mixture	0.5% methylcellulose suspension; uniformity confirmed by triplicate HPLC assay at top, middle, bottom of the batch (RSD 2.1%, within the 5% acceptance limit); concentration re-verified weekly through the dosing period, all results within 95-105% of nominal

Common inspection findings this record prevents

A reported dose that rests on a nominal concentration with no analytical confirmation of what was actually in the dosing preparation.
A characterization record for one batch while a different, unrecorded batch was actually used in the study.
No documented storage or distribution chain, so identity cannot be traced from receipt to dosing.
A carrier mixture assumed homogeneous with no uniformity data.

How to adapt this record

Set your study number and article identifiers in the header.
If your study uses more than one test or control article batch across its duration, add a row per batch and confirm each has its own characterization and stability basis.
Pair with the GLP Study Plan, which should reference this record rather than repeating its content.
Confirm every regulation cited against the current published version before issue.