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What is IQ OQ PQ and why do Manufacturers need it?

In manufacturing, the process of designing, testing, and validating equipment and systems is critical to ensuring quality, reliability, and compliance with regulations. One widely accepted method for achieving this is through the validation of IQ OQ PQ.

IQ, OQ, PQ stands for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). These are three distinct stages of validation that are carried out sequentially, and each stage involves specific tests and documentation to ensure that the equipment or system being validated meets the requirements and specifications for its intended use.

The IQ stage verifies that the equipment has been installed correctly and that all components are present and properly installed. This includes checking that the equipment is connected to the appropriate power supply, that it is grounded correctly, that all necessary connections have been made, and that the equipment has been calibrated and verified according to its technical specifications.

The OQ stage is where the equipment or system is tested to ensure that it operates according to its specifications under normal conditions. This stage involves testing the system's functionality, verifying that it meets the manufacturer's specifications and that it can perform the tasks for which it was designed. This includes testing things like control systems, alarms, and interlocks, as well as verifying that the system can operate within specific temperature, humidity, and pressure ranges.

The PQ stage is the final stage of the validation process and focuses on demonstrating that the equipment or system consistently produces the desired results under normal operating conditions. This stage involves running the equipment or system for an extended period while monitoring its performance and ensuring that it meets the requirements for its intended use.


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The Relevance of IQ OQ PQ in Manufacturing

IQ OQ PQ compliance provides a structured equipment and system validation approach that ensures quality, reliability, and compliance. By following the IQ OQ PQ approach, manufacturers can ensure that their equipment and systems operate and are installed correctly, that they meet the intended specifications, and that they are consistent and reliable over time.

In addition to ensuring quality and reliability, the use of IQ OQ PQ can also help manufacturers comply with regulatory requirements. Many regulatory agencies require manufacturers to provide evidence that their equipment and systems have been validated before they can be used in production. By using the IQ OQ PQ approach, manufacturers can demonstrate that they have taken the necessary steps to validate their equipment and systems and ensure that they meet regulatory requirements.

Therefore, the IQ OQ PQ process is implemented to:

  1. Create a documented record that demonstrates the correct installation of mechanical, piping, or IT systems and ensures they meet the design specifications. This process also confirms that the system or process yields consistent and reproducible results under varying loads.

  2. Prevent installation, operational, and performance errors from occurring.

  3. Ensure dependable system performance.

“Commissioning” vs the “IQ OQ PQ” Process

The primary purpose of commissioning is to test the engineering aspects of a new plant and ensure it is functioning correctly. This process involves all equipment in the manufacturing facility. On the other hand, the IQ OQ PQ process is distinct in several ways:

  • It only applies to equipment that has a direct or indirect impact on product quality and user safety, as well as the components within those systems that are product contact critical or operationally critical. This determination is made using system and component impact assessments, as well as risk management tools.

  • Regulatory authorities place particular emphasis on the IQ OQ PQ process when evaluating the medicines produced in the facility.

  • The IQ OQ PQ process is much more rigorous, requiring a focus on documentation.