Qualifying and Optimizing GC Instruments and Methods in High-Throughput Regulated Laboratories

Three key areas of focus for qualifying and optimizing instruments and methods in high-throughput, fast-paced regulated laboratories are: 1) Staying compliant with instrumentation qualifications, 2) Ensuring lab personnel are properly trained to perform methods and understand their purpose and intent, and 3) Making sure methods are easy to follow and contain all the pertinent information. This talk provides a high-level overview of installation, operation, and performance qualifications for GC instrumentation. It reviews FDA 483 observations that are still commonly found today. The key properties to be evaluated for GC instrumentation and the importance of choosing the right test samples are discussed.

Ignoring these key areas can be time-consuming and interrupt the flow of lab production. For example, often leaving out seemingly inconsequential information can lead to investigations and having to re-run methods. That’s why it is important to understand fundamental GC operation and theory when interpreting compendial methods and to write methods that clearly convey the purpose and intent of the method. Specific details such as vendors and part numbers for consumables like syringes, septa and injection liners, and details on sample preparation are necessary.

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