RECORDREFERENCE OUTLINE

Test Item Characterisation Record

Characterisation record establishing what was actually administered: identity, strength, purity and composition determined before dosing, stability for the dosing formulation at the concentrations used rather than the neat substance, homogeneity verified with sampling positions named, the vehicle and control article characterised too, plus accountability and reserve samples. Maps to 21 CFR Part 58 and the OECD GLP Principles.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
21 CFR Part 58OECD GLP Principles
DOCUMENT TYPE
Record
LAST UPDATED
August 2026
PURPOSE

A nonclinical safety study is evidence about a substance. If the identity, strength, purity, composition and stability of what was actually administered are not established, the study is evidence about something unknown, and no rigour downstream repairs that. The characteristic failure is characterising the neat substance thoroughly and the dosing formulation not at all, so recorded dose and delivered dose diverge invisibly.

What's Inside

✓Identity, strength, purity and composition with the analytical methods named and the determination dates recorded
✓Stability of the neat test item, covering the storage conditions and the period the study actually spans
✓Stability of the dosing formulation at the concentrations used, held separately from the neat item
✓Homogeneity verification with sampling positions named, because suspensions separate between preparation and the moment of dosing
✓Vehicle and control article characterisation, so the comparator the whole study rests on is itself defined
✓Receipt, storage, distribution and return accountability, reconciling what arrived against what was actually administered
✓Reserve sample retention with the quantity, storage conditions and retention period all stated explicitly

How to Use It

1Characterise before dosing; work done after the in-life phase describes the material as it is now, not as administered
2Establish stability for the formulation at the concentrations actually used, not only for the neat substance in its container
3Verify homogeneity and name the sampling positions, or recorded dose and delivered dose diverge with nothing to detect it
4Characterise the vehicle and the control article too, because an undefined comparator undermines the comparison the study rests on
5Reconcile accountability against the dosing records, since an unexplained shortfall is a question about the study, not the store
6Set the reserve sample quantity so a later question can actually be answered, rather than merely so a sample exists
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Identity, Strength, Purity and Composition
2Stability
3Dosing Formulation Verification
4Vehicle and Control Article
5Receipt, Storage, Distribution and Return
6Reserve Samples
REGULATORY CONTEXT

21 CFR Part 58 and the OECD GLP Principles require characterisation of test, control and reference items — identity, strength, purity, composition and stability — and verification of dosing formulations for concentration, homogeneity and stability. Neither specifies which methods characterise your substance adequately, how long stability must be demonstrated for your study, or what reserve quantity suffices; those determinations belong to the study director and the sponsor. The record structure is SPEQ practitioner synthesis.

MAPPED STANDARDS
21 CFR Part 58OECD GLP Principles
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