Installation Qualification confirms that the equipment is installed and configured in full compliance with the manufacturer's specifications. This includes:

• Inspection of the installation site and environmental conditions.
• Recording instruments' and control systems' data, including serial numbers and software versions.
• Installation and connection of auxiliary devices.
• Registration of all serial numbers, firmware versions, and calibration dates.
• Conducting an initial inspection to ensure compliance and check for any damage.

The IQ protocol covers equipment identification data, installation requirements, and operating conditions, as well as a checklist for verifying correct installation. The final report records all observations and results confirming that the equipment meets the specified requirements.

Operational Qualification verifies that the equipment's performance meets user requirements within the operating parameters specified by the manufacturer. This process includes identifying and testing equipment characteristics that may affect the quality of the final product.

• Testing the full operational range, including limit tests at the upper and lower boundaries.
• Simulating failure modes to verify the equipment's error detection and handling mechanisms.
• Testing the equipment's compatibility with other systems or devices it will interact with during operation.
• Testing equipment performance under various environmental conditions to assess its reliability under changing parameters (e.g., temperature, humidity).
• Verifying the integrity and accuracy of data generated by the equipment to ensure compliance with traceability and safety requirements.
• Performing sequential tests to validate the equipment's proper functioning within the sequence of operations in the production process.
• Conducting load tests, including maximum and variable loads, to evaluate the equipment's performance under different operating conditions.

The OQ protocol includes testing tasks, methodologies, and acceptance criteria that must be met for successful testing. The final report provides detailed results and conclusions about whether the equipment complies with the specified standards.

Performance Qualification verifies the equipment and its components under actual operating conditions, focusing on stability, accuracy, and reproducibility during analyses.

• Verification of operating conditions, including equipment limits, operating parameters, and input data.
• Preparation and analysis of data recorded during testing, calibration, and validation.
• Conducting tests to ensure the stability and accuracy of analysis results.
• Developing a plan and description of sampling methods for analysis.
• Applying data analysis methodologies to make scientific and risk-oriented decisions based on statistical information.
• Determining variability limits and developing action plans for the identification of non-conformities.
• Approval of the PPQ protocol by responsible departments such as the Quality Department.

The primary goal of Performance Qualification (PQ) is to ensure the stability and accuracy of analyses by monitoring equipment performance and documenting its operation over a specified period, guaranteeing consistent results.