Certified Pharmaceutical GMP Professional Practice

What is the primary purpose of Installation Qualification (IQ)?

1. To validate a process in commercial manufacturing

2. To provide evidence that equipment operates in accordance with design specifications

3. To ensure that equipment and premises are installed per design specification and GMP

4. To assess performance consistency in long-term operations

The correct answer is: To ensure that equipment and premises are installed per design specification and GMP

The primary purpose of Installation Qualification (IQ) is to ensure that equipment and premises are installed per design specifications and Good Manufacturing Practices (GMP). This process is a crucial part of the validation life cycle, which typically follows a series of systematic steps to guarantee that any equipment or facility is set up correctly before it begins to be used in production. During the IQ phase, verification is conducted to confirm that the installation aligns with the intended design, which includes checking that the equipment is properly configured and set up according to the documented installation specifications. Additionally, adherence to GMP guidelines during installation is assessed to prevent risks associated with improper setup that could compromise the quality of products manufactured later. This step is foundational because if the installation is faulty or does not meet specifications, subsequent qualifications and validations, such as Operational Qualification (OQ) and Performance Qualification (PQ), may not yield valid or reliable results. Therefore, ensuring that everything is correctly installed and complies with established standards is essential for maintaining quality assurance in pharmaceutical manufacturing.