Test substances tracking

The movement of the test substance during the course of a Held residue study must be tracked to assure that the integrity of the test substance is maintained [40 CFR 160.185(a)(10)]. The COC can be accomplished in a number of ways. In the simplest situation, every person signs their name on a piece of paper that accompanies the test substance when they handle the test substance. Eventually the COC will list the names of all those who handled the test substance during the course of the study. Shipment, receipt, weighing, and final disposition of the test substance container must all be tracked and promptly recorded if an unbroken COC is to be present at the end of the trial. The completed COC becomes an essential part of the field residue trial record. 

For FieldNotes, the general log for the test substance will automatically track usage for each application at all sites. When the same container of test substance is used for several studies, the data will appear to be atypical. If QA is auditing individual study data, the numbers will not seem to be accurate for a particular study. QA must be made aware when one container is used for different studies during the audit. Consequently, sending a separate container of test substance for each trial and/or study is recommended in order to facilitate tracking during the audit. 

For example, the requirements for tracking the receipt and use of the test substances and test animals are the same. The need for the calibration of the test equipment, storage, and archives are the same. 

I am going to start the discussion by tracking a test chemical from its arrival in the laboratory to its final archiving and storage. However, as you will see, the required analyses are not limited to analysis of the test substance. 

Some procedures for detection and determination of the damage caused by autoxidation are aimed at the determination of rather indefinite substances for example, the ASTM D-4625-92 standard test for fuel stability on storage consists of tracking the amount of insoluble gums formed by oxidation at a slightly elevated temperature . 

December 30 The U.S. Olympic Committee releases results showing that seven top American athletes—six track and field athletes and a cyclist—had tested positive for banned substances the previous summer. 

Toxicity test procedures Sample toxicity must be tracked to assess if the substance responsible has degraded over time. Tighter concentration intervals may be required in order to detect smaller incremental changes in toxicity. 

If the toxicant has been identified, i) use chemical specific analysis for tracking the sources, and ii) evaluate the effects of the treatment plant on altering the toxicant. This approach involves testing the source streams for the toxicant using chemical-specific analysis. Chemical specific analysis should also be conducted on the combined influent and effluent streams to assess the effects of the ETP on the substance responsible for toxicity. Effluent residence times must be considered to ensure the same batch of water from the influent and effluent is analyzed (U.S. EPA, 1989). Once the source of the toxicant(s) has been identified, the SI could go further into the process to identify sub-component streams, or the TRE could proceed to a TTE for the source stream(s). 

When TLC is used to track a specified impurity in the drug substance, it is likely to be applied to the subsequent drug product method. A plate must be prepared to show that required levels of LOD and LOQ can be achieved for the specified impurity in the presence of excipients. This is known as a spiking experiment. The specified impurity is prepared and spiked into the vial of the drug product at different levels, then applied to the TLC plate to ensure it can be extracted to meet the requirement of LOD and LOQ. If no specified impurities are being tracked by TLC, this validation test can be excluded. 

Specifications—methods, tests, limits, rationale, validation Batch tracking—drug substance and product... 

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