Analytical Instrument Qualification vs System Suitability Testing

Analytical Instrument Qualification (AIQ) and system suitability testing (SST) are both important processes in the pharmaceutical industry that ensure the accuracy, reliability, and consistency of analytical instruments used for testing drug products. However, there are some key differences between these two processes.

1. Purpose:

- AIQ: The primary purpose of AIQ is to establish documented evidence that an instrument is suitable for its intended use and can consistently produce accurate and reliable results.

- SST: The main purpose of SST is to verify that an analytical system (instrument, method, and sample preparation) is capable of providing reliable and consistent results for a specific analysis or test.

2. Scope:

- AIQ: AIQ focuses on the qualification of individual instruments, including their hardware, software, and associated components. It ensures that the instrument meets predefined acceptance criteria for various parameters such as accuracy, precision, linearity, sensitivity, etc.

- SST: SST evaluates the overall performance of an analytical system by assessing its ability to meet predefined acceptance criteria for a specific analysis or test. It includes checking parameters such as resolution, peak symmetry, retention time reproducibility, limit of detection/quantification, etc.

3. Timing:

- AIQ: AIQ is typically performed during the installation phase of a new instrument or after any major modifications or upgrades to an existing instrument.

- SST: SST is performed on a routine basis before starting any analysis or test to ensure that the analytical system is in a state of control and capable of producing accurate and reliable results.

4. Documentation:

- AIQ: AIQ requires comprehensive documentation including protocols, test results, calibration certificates, maintenance records, etc., which serve as evidence that the instrument has been qualified according to established standards.

- SST: SST also requires documentation but focuses more on recording specific parameters related to the analysis being performed. These records help demonstrate that the system was suitable for use during a particular analysis.

5. Regulatory requirements:

- AIQ: AIQ is a regulatory requirement in the pharmaceutical industry, and guidelines such as USP <1058> provide recommendations for the qualification of analytical instruments.

- SST: SST is not explicitly required by regulations but is considered a best practice to ensure the reliability and accuracy of analytical results. It is often included in method validation protocols and Good Laboratory Practices (GLP) guidelines.

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Resource Person: Ershad Moradi

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