USFDA Guidelines for Equipment Qualification

Process Validation is conducted to ensure consistent delivery of quality products meeting its predetermined specifications/requirements and quality characteristics. This enables to ensure the complete safety & efficacy of medical device.

IQ, OQ, PQ protocols are methods for demonstrating that equipment being used or installed will offer a high degree of quality assurance such that production processes will consistently manufacture products that meet quality requirements.

Installation Qualification (IQ)

Newly installed or modified equipment must first be validated to determine if it’s capable of producing the desired results through Design Qualification (DQ)—a protocol defined as the documented verification of a proposed design’s ability to meet the requirements it needs to fulfill.

Operational Qualification (OQ)

Operational qualification (OQ) is performed after meeting each protocol of IQ. OQ’s purpose is to determine that equipment performance is consistent with the user requirement specification within the manufacturer-specified operating ranges. In action, this means identifying and inspecting equipment features that can impact final product quality.

Performance Qualification (PQ)

The final step of qualifying equipment is PQ. In this phase, the qualification and validation team verify and documents that the user requirements are verified as being met. These user requirements should include the normal operating range required (as defined and signed off on by QA and verified in the DQ). Once you've qualified the equipment, you can develop each process required for each product. Then, once each process is fully developed, it can be validated.



IZiel’s Onshore-Offshore Model works with 1 Onsite Member supported by a team of 3-4 engineers from our Technical Center in India. Typically, the data is collected, evaluated and evidence is developed from the process design stage throughout production. Our Model enables the company to complete the project faster and in a cost-effective manner.



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