For pharmaceutical companies and other industries that manufacture products, installation qualification (IQ) is an important part of the quality assurance process. It verifies that all equipment used in the production process has been installed correctly, meets the manufacturing specifications, and functions as designed. In this blog post, we'll break down what IQ is and how it works.
What is Installation Qualification?
Installation qualification is a type of document that confirms that a piece of equipment has been properly installed according to the manufacturer’s specifications and/or industry standards. It also ensures that safety requirements are met and that any potential risks or hazards are identified before using the equipment in production. This document serves as proof that the equipment was installed correctly and functions properly.
The IQ Process
The IQ process typically involves several steps:
1) Evaluation of the supplier's documentation - This includes reviewing any instructions provided by the vendor regarding installation, operation, maintenance, calibration, etc., to ensure they meet all applicable regulations and standards.
2) Inspection of the installation site – This includes verifying that all safety components are in place prior to beginning installation; checking for proper ventilation; inspecting electrical connections; ensuring there is adequate space for personnel to work safely around the equipment; confirming power sources are appropriate; etc.
3) Testing of installed equipment – Once installation is complete, tests should be conducted to ensure proper operation; these may include performance tests, functional tests with actual product being run through the system, or simulated product runs using dummy material. Tests should also be performed on any alarms or interlocks associated with the system to confirm their function as designed.
4) Documentation Review – The final step in IQ is reviewing all documents generated during testing for accuracy and completeness prior to filing them for recordkeeping purposes.
Installation Qualification (IQ) plays an integral role in ensuring quality control processes are followed when installing new pieces of equipment in a production facility. By evaluating supplier documentation, inspecting installation sites, testing installed equipment, and reviewing related documents, companies can be confident their installations meet all applicable standards while minimizing safety risks associated with improper setup or use of such systems. With an effective IQ process in place, manufacturers can rest assured their systems will operate optimally while complying with current regulations and industry best practices.
