Installation qualification (IQ; German translation: Installationsqualifizierung) documents that the installation of production facilities, systems and equipment has been carried out in accordance with the previously approved plan, the manufacturer’s recommendations and/or the user requirements.

The most important aspects of IQ include:

• Examination of the documentation: All documents related to the installation must be complete and correct.
• Inspection of the systems: Execution of a physical inspection of devices and systems in order to confirm that they are properly installed.
• Compliance with standards: Confirmation that the installation complies with industry standards and legal requirements.
• User requirements specification and functional specification: Checking whether all specifications are met in accordance with the user requirements specification (translation into German: Lastenheft) and functional specification.
• Change tracking: Documentation of all changes made to the installation process compared to the approved design.

Installation qualification ensures that all installed devices and systems meet the requirements and specifications (German: Spezifikationen). This is an important step toward ensuring quality and safety in the manufacture of drugs.

If your pharmaceutical company has an upcoming GMP inspection by foreign authorities, we would be happy to support you with our language expertise. Contact us for a quote by e-mail or phone — our pharmaceutical interpreters and GMP translators ensure flawless communication.