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Test and Control Articles
Test and Control Article Characterization (Receipt, storage, mixing, characterization, reserve samples, documentation)
The identity, strength, purity, or other characterization that will define test or control articles will be determined and documented for each batch or lot. Test and control article identity, storage, handling, and use will be defined in the study protocol. The methods of synthesis, derivation, or fabrication of test articles will be documented by the sponsor and all essential information will be provided to the study director. Protocols will include reference to the location of such documentation. Control articles will be characterized by their labeling. Stability under conditions of use will be determined by the sponsor or testing facility either prior to study initiation or concomitantly according to written procedures (refer to Texas A&M Test and Control Article SOP).
Mixtures of Test and Control Articles
All test and control articles mixed with a carrier will be appropriately tested for uniformity of the mixture and periodically tested for concentration of the test or control article in the mixture. Stability of the mixture will be tested prior to study initiation or concomitantly according to written procedures.
Test article characterization must be performed in compliance with the GLP regulations. Laboratories analyzing test articles will be approved by Texas A&M’s QAU unless the sponsor selects a laboratory that has been inspected and approved by the sponsor in which case the sponsor will provide Texas A&M with an inspection report verifying GLP compliance.
Test and Control Article Storage
Test and control article storage containers will be labeled with the name, chemical abstract number or code, batch and/or lot number, expiration date (as applicable) and storage conditions. Test and control articles will be stored under conditions sufficient to maintain viability and stability. Records establishing traceability will be maintained from receipt of test and control articles to final disposition.
Reserve Samples of Test and Control Articles
Studies longer than four weeks in duration will have reserve samples of test and control articles retained for each batch or lot. Either Texas A&M or the sponsor will retain the reserve samples as agreed in writing and signed by both Texas A&M and the sponsor.