Test Article Characterization – A GLP Requirement

5 Key Points of Test Article Characterization (TAC)

Test Article Characterization
Good Laboratory Practices (GLP)

Identity

The name under which the article will be tested Include CAS number, lot or batch, if applicable

Composition

The list of ingredients making up the test article

Strength

The stated concentration of an active ingredient in a test article mixture

Purity

The fraction that is the active ingredient (relative to impurities), usually expressed as a percent

Stability

The duration for which the test article will remain undegraded under the storage conditions provided

Why is Test Article Characterization (TAC) necessary?

When a study is conducted according to the Good Laboratory Practices regulations (GLPs), providing characterization of the material to be tested (the test article) to the Testing Facility (MB Research) is required.

Do you have characterization of the test article (e.g., Certificate of Analysis, or similar)?

Yes – Please provide this to MB Research prior to study initiation (signing the protocol, beginning the experiment).

No –Select ‘no test article characterization’ on the Sponsor Request section of the MB Research protocol. No further action is necessary. Refer to the GLP Compliance section below.

If yes, was test article characterization/analysis performed according to Good Laboratory Practices (GLPs), Good Manufacturing Procedures (GMPs), or neither*?

 Please select GLP, GMP, or non-GLP/non-GMP on the Sponsor Request section of the protocol.

Does your TAC include all five of the following GLP-required parameters?

Yes – The study will be in complete GLP compliance. No further action is necessary.

No – Refer to the GLP Compliance section below.

Good Laboratory Practices (GLP) Compliance 


A GLP compliance exception statement appears in the study report when TAC –

(1) is not provided

(2) is not provided prior to study initiation (signing the protocol)

(3) does not include all five of the parameters, and/or

(4) is not performed according to GLPs

MB Research Labs is a contract GLP toxicology lab with over 45yrs of experience in chemical, consumer product and cosmetic safety assessment.

www.mbresearch.com

MB specializes in in vitro toxicology testing and development of alternatives to animal models for toxicological assessments.